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Original Article
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Suebsarn Ruksakulpiwat, RN, MMed
Department of Medical Nursing, Faculty of Nursing, Mahidol University, Bangkok 10700, ailand.
Intervention Enhancing Medication Adherence in
Stroke Patients: An Integrative Review
ABSTRACT
Objective: is review aimed to systematically identify and analyze randomized controlled trials (RCTs) reported
in the literature that were related to interventions targeted at enhancing medication adherence in stroke patients.
Materials and Methods: e Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
system was applied to present the process ow, including study identication, screening, exclusion, and inclusion.
e PubMed electronic database was searched, and the reference lists of relevant studies were reviewed from 2015
until 2020 to identify relevant RCTs.
Results: e results identied nine relevant RCTs, which included a medication-taking reminder mobile application
(Medisafe), health empowerment interventions, telehealth education, and motivational interviews as the medication
adherence enhancement interventions that have been most oen used in the past ve years. Furthermore, these
RCTs mainly aimed to improve patients’ medication adherence, physical activity, and clinical outcome, such as
blood pressure and high-density lipoprotein cholesterol.
Conclusion: is integrative review has implications for the heightened recognition of the necessity for interventions
aimed at enhancing patients’ adherence to their medication, and that could be applied in clinical practice.
Keywords: Integrative Review; Medication Adherence Intervention; Stroke; Nurse (Siriraj Med J 2021; 73: 429-444)
Corresponding author: Suebsarn Ruksakulpiwat
E-mail: suebsarn25@gmail.com
Received 23 November 2020 Revised 26 January 2021 Accepted 28 January 2021
ORCID ID: https://orcid.org/0000-0003-2168-5195
http://dx.doi.org/10.33192/Smj.2021.57
INTRODUCTION
Stroke is a leading cause of mortality and disability
globally.
1
In 2016, there were 5.5 million deaths and
116.4 million Disability-Adjusted Life Years (DALYs)
lost due to stroke. Although age-standardized mortality
rates have signicantly fallen from 1990 to 2016, the
stroke burden remains high.
2
Patients with a history
of stroke have a risk of recurrence, ranging from 1.8%
within one month to 43% within 5 years.
1
e mortality
rate in the beginning stage of recurrent stroke is 56.2%,
which is higher than for the rst stroke.
1
Hence, critical
improvements in the secondary prevention of stroke are
required to decrease these risks, and there is a particular
need to reduce the severity and mortality from stroke.
3,4
Adherence to stroke medication is considered critical to
preventing the recurrence of stroke
5
, but is oen sub-
optimal in many stroke survivors. Antihypertensive
therapy, cholesterol reduction with statins, antiplatelet
agents, or the treatment of atrial brillation with oral
anticoagulants are all instances of evidence-based secondary
stroke prevention medication.
6
Previous research has
stated that management in combination with preventive
medication could reduce the recurrence of ischemic
events by about 75%.
7,8
However, approximately 50% of
chronic disease patients do not adhere to their medical
therapy
9,10
, and this lack of adherence to medication
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dramatically impacts their health outcomes.
11
In the United
States, general medication nonadherence is estimated
to be responsible for roughly 125,000 deaths per year,
at least 10% of hospitalizations, 23% of nursing-home
admissions
11
, and a substantial increase in morbidity
and mortality.
12-14
For stroke patients, a previous study
showed that about one-third of stroke survivors are
considered to be nonadherent to their medication.
15
Various interventions have been proposed and
implemented to enhance patient adherence to medication,
such as behavior therapy and the dissemination of
information materials related to the importance of
medication adherence.
16-20
Moreover, a previous study
suggested that utilizing functional interventions in daily
practice and management for both professionals and
patients could be most promising for facilitating greater
medication adherence.
21
Nevertheless, research, including
stroke patients’ preferences for medication adherence
intervention, is profoundly lacking. A literature review
was conducted on this subject, but we found no reported
studies in which stroke patients were participants among
the ve meta-analyses and systematic reviews that we
found and that covered 217 innovative studies.
9,11,14,18
Therefore, it was decided to perform an integrative
review to identify and analyze medication adherence
interventions in stroke patients. Specically, it was decided
to concentrate on summarizing these studies and the eect
of dierent medication adherence interventions on the
medication adherence of stroke patients. e following
questions were identied to drive this integrative review:
1) What kinds of interventions and theoretical
frameworks used for medication adherence interventions
in stroke patients are reported across studies?
2) What eects do the dierent types of interventions
have on the medication adherence of stroke patients?
MATERIALS AND METHODS
Identication of relevant studies
In this review, the PubMed electronic database
was searched, and the reference lists in relevant studies
were reviewed to identify randomized controlled trials
(RCTs) reporting interventions for enhancing medication
adherence in stroke patients. e following combined
search terms were utilized: (Stroke OR cerebrovasc*
disorders OR cerebrovasc* disease OR cerebrovasc*
accident OR brain isch?emi* OR isch?emi* cerebral
attack OR brain attack OR intracranial h?emorrhage*
OR CVA) AND (Medication Adherence OR Medication
Nonadherence OR Medication Noncompliance OR
Medication Persistence OR Medication Compliance
OR Medication Non-Compliance). e detailed search
strategy is shown in Table 1. e search phrases were used
according to the fundamental guidelines of the database.
Moreover, the authors reviewed the reference lists of the
relevant literature, and one additional article was identied.
e Preferred Reporting Items for Systematic Reviews
and Meta-Analyses (PRISMA)
22
system was applied for
the process ow, including the identication, screening,
exclusion, and inclusion of the literature studies (Fig 1).
e inclusion criteria, as well as exclusion criteria for
eligible studies, are shown in Table 2.
Study selection
First, the researcher screened the titles and abstracts
of the qualied studies. Subsequently, the full text was
also assessed to decide whether or not it was relevant to
the present study. Inclusion criteria were implemented
to guarantee that only studies considered relevant to the
study objective were included. Similarly, exclusion criteria
were utilized to screen out literature not aliated with
a review (Table 2). A literature review paper matrix was
designed (Supplementary Table 1), which included the
following data for each study: references, countries, and
duration of intervention, target population, sample size,
problem and purpose, theoretical framework, intervention
details, medication adherence measures (reliability,
validity), methodological problems, key ndings, and
implications.
RESULTS
Search results and description of the studies
Fig 1 shows that 25 references were classied throughout
the initial search (one was included through a list of
references searched because of the study’s relevance
23
), of
which 17 articles were excluded in the title and abstracts
screening phase by following the inclusion and exclusion
criteria (Table 2), leaving 9 articles that qualied for the
full-text screening.
Table 3 shows the included RCTs, which were
published between 2015 and 2018 and were conducted
in 4 countries, namely China (n = 3), United States (n
= 3), Pakistan (n = 2), and New Zealand (n = 1). e
research duration reported varied across the studies
(from the enrollment to the nal assessment of one
participant), whereby 4 studies were performed over 3
months, 3 studies had a duration of between 3 months
and 6 months, and 2 RCTs involved studies over more
than 6 months. e target populations in the included
studies were individuals with stroke, including ischemic
stroke (n = 5), non-specied subtypes of stroke (n = 3),
hemorrhagic stroke (n = 1), transient ischemic attack
(n = 1), and hypertensive patients (n = 1), which were
Ruksakulpiwat.
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TABLE 1. Search strategies.
Database Search Search String
PubMed 1 (((((((("Stroke"[MeSH Terms] OR "Stroke"[Text Word] OR
"cerebrovascular"[All Fields]) AND ("disease"[MeSH Terms] OR
"disorders"[Text Word])) OR "cerebrovascular"[All Fields]) AND
("disease"[MeSH Terms] OR "disease"[Text Word])) OR
"cerebrovascular"[All Fields]) AND ("accidents"[MeSH Terms] OR
"accident"[Text Word])) OR ("brain"[MeSH Terms] OR "brain"[Text
Word])) AND (("cerebrum"[MeSH Terms] OR "brain"[MeSH Terms]
OR "cerebral"[Text Word]) AND ("attack"[All Fields] OR "attacked"[All
Fields] OR "attacker"[All Fields] OR "attacker s"[All Fields] OR
"attackers"[All Fields] OR "attacking"[All Fields] OR "attacks"[All
Fields]))) OR "Stroke"[MeSH Terms] OR ("intracranial"[All Fields] OR
"intracranially"[All Fields]) OR ("Stroke"[MeSH Terms] OR "CVA"[Text Word])
2 ("medication adherence"[MeSH Terms] OR Medication
Adherence[Text Word]) OR ("medication adherence"[MeSH Terms]
OR Medication Nonadherence[Text Word]) OR ("medication
adherence"[MeSH Terms] OR Medication Noncompliance[Text Word])
OR ("medication adherence"[MeSH Terms] OR Medication Persistence[Text
Word]) OR ("medication adherence"[MeSH Terms] OR Medication
Compliance[Text Word]) OR ("medication adherence"[MeSH Terms]
OR Medication Non-Compliance[Text Word])
3 1 AND 2
TABLE 2. Study criteria.
Inclusion Exclusion
1 Adult patients (18 years or older) Stroke as a complication
2 Diagnosis of stroke (including ischemic stroke, Studies including children or adolescents under
hemorrhagic stroke, or transient ischemic attack) 18 years old, adults living in a nursing home, or the
hospital who received the assistance with the medication
adherence intervention
3 A randomized controlled trial aimed at Conference proceedings, abstracts, protocol, pilot study,
improving medication adherence published from and review articles
January 1, 2015, to December 31, 2020
4 Described in the English language Targeted only caregivers of stroke patients
5 Included an outcome measure of medication
adherence such as adherence to combination
therapy guide, elicitation of compliance and
adherence behaviors questionnaire, medication
adherence rating scale, medication event
monitoring system, or patient medication
adherence questionnaire
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included because of the study relevance from the bibliography
search. e most commonly reported control and the
experimental group sample sizes were >50 to 100 (n = 3).
Interventions enhancing medication adherence in stroke
patients
Intervention and purpose
Medication-taking reminder mobile applications
(e.g., Medisafe), health empowerment interventions,
telehealth education, and motivational interviews are
the medication adherence enhancement intervention
that has been most oen used in the past ve years.
Nevertheless, Medisafe has never been used in stroke
patients before.
23
Furthermore, this review found that
interventional studies mainly aim to improve medication
adherence, physical activity, and clinical outcomes (blood
pressure, high-density lipoprotein cholesterol, etc.).
23-31
eoretical framework
In this review, the theory of health empowerment
24
,
self-ecacy theory
24
, guidelines for the secondary prevention
of ischemic stroke and transient ischemic attack
25,26
, the
health belief model
27,30
, and social cognitive theory
30
were
applied to guide the interventions for enhancing medication
adherence in stroke patients (Table 3), while 4 out of the
9 RCTs did not specify a theoretical framework.
23,28,29,31
e health belief model (2 out of 2) and guidelines for the
secondary prevention of ischemic stroke and transient
ischemic attack (2 out of 2) were identied as the most
prominent and signicant determinants of medication
adherence compared to the other frameworks. Only 1
study used the social cognitive theory as a framework,
and medication adherence and blood pressure as the
clinical outcomes in this study were signicantly improved
aer the intervention.
30
Regarding the theory of health
Fig 1. Flow chart diagram displaying the selection method of qualied studies.
Ruksakulpiwat.
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TABLE 3. Overall characteristics of the included studies.
Variables Count
Year
2018
23,27,29,31
4
2017
26
2
2016
24,25
1
2015
28,30
2
Countries
China
25-27
3
United States
23,24,31
3
Pakistan
29,30
2
New Zealand
28
1
Duration of intervention
0 – 3 months
23,27,29,30
4
> 3 – 6 months
24,25,31
3
> 6 – 12 months
26,28
2
Target population
#
Ischemic stroke
24-27,30
5
Non-specied subtype of stroke
28,29,31
3
Hemorrhagic stroke
24
1
Transient ischemic attack
31
1
Hypertension*
23
1
Theoretical Framework
##
Unspecied
23,28,29,31
4
Health Belief Model
27,30
2
Guidelines for the Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack
25,26
2
The theory of health empowerment
24
1
Social Cognitive Theory
30
1
Self-efcacy Theory
24
1
Medication adherence measures
The 8-item Morisky medication adherence scale (MMAS-8)
23,29,30
3
The 4-item Morisky medication adherence scale (MMAS-4)
24
1
Modied health behavior scale
25
1
The proportion of medication-taking was compared between the control and intervention groups
26
1
The Health Promoting Lifestyle Prole II
27
1
The Tablets Routines Questionnaire (TRQ)
31
1
Asking whether (in the past seven days) participants had taken all of their medication as prescribed. 1
Moreover, patients were asked to indicate the number of doses/pills missed, if they just forgot (yes/no),
the reason for the missed dose(s), and to provide detail if side effects were noted
28
Sample (n)
Control (C) Experimental (E) C E
0 – 25
31
0 – 25
31
1 1
> 25 – 50
25
> 25 – 50
25
1 1
> 50 – 100
27,29,30
> 50 – 100
27,29,30
3 3
> 100 – 200
24,28
> 100 – 200
24,28
2 2
> 200 – 300
23
> 200 – 300
23
1 1
> 300
26
> 300
26
1 1
#One study may consist of > 1 target populations
##One study may apply > 1 theoretical framework
*is study was included through other resources because of the study's relevance
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empowerment and self-ecacy theory, although there
was no statistical dierence in medication adherence
between the intervention and control groups in the studies
that used these frameworks, other components, such as
self-ecacy in illness management and self-management
behaviors, were reported to be statistically signicant.
24
Medication adherence measurements
Six studies used dierent medication adherence report
scales with acceptable reliability and validity to measure
the medication adherence, while the other 3 RCTs did not
provide this information (Table 3). e 8-item Morisky
medication adherence scale (MMAS-8) (reliability: α =
0.83, validity: 93% sensitivity, 53% specicity) (n = 3) was
oen used to evaluate the medication adherence
23,29,30
,
followed by the 4-item Morisky medication adherence
scale (MMAS-4) (reliability: α = 0.55, average item-test
correlation: 0.65) (n =1)
24
, modied health behavior
scale (content validity index: 0.85, reliability: α = 0.878,
the split-half reliability: 0.801) (n = 1)
25
, and the Health
Promoting Lifestyle Prole II scale (reliability: α = 0.853,
split-half reliability: 0.781, test-retest reliability: 0.845)
(n = 1)
27
, respectively.
DISCUSSION
Although the prevalence of stroke is on the rise
globally, medication can help prevent future strokes, and
hence medication adherence is critical for preventing future
strokes. However, the medication adherence rate is not at a
satisfactory level.
28,29
e present integrative review found
that medication-taking reminder mobile applications,
such as Medisafe, have, to the best of our knowledge,
not yet been used to improve medication adherence
and clinical outcome in stroke patients.
23
Although the
literature review revealed a previous interventional study
that proposed the use of short message service (SMS)
reminders to improve patients’ medication adherence,
there were limitations reported with this system; for
example, SMS messages may not be received by patients
if they provide an incorrect contact phone number, and
also, as SMS is a one-way communication system, there
is no guarantee that patients will rigorously comply with
the treatment.
32,33
e use of reminders can though,
provide a solution for some patients, mostly those with
unintentional nonadherence, such as patients willing to
take medicine but who may forget or miss the proper
time.
34
e research explained that 22% - 73% of patients
in diverse populations regularly reported forgetting to take
medication, which is the most frequently cited reason for
nonadherence in a number of studies.
35-44
Accordingly, a
simple intervention such as Medisafe seems to perform
well in daily practice and is comfortable for both patients
and healthcare professionals to handle and adapt this
intervention to prevent instances of nonadherence to
medication.
e included studies’ key strengths, namely for the
RCTs, in this review, need to be reported. First, in this
integrative review, a total of 9 RCTs were included. ese
studies had followed the design principles for randomized
controlled trials, including randomly assigning participants
to each group to ensure an equal chance of participation
(minimized selection bias and sampling error). Moreover,
RCTs display a higher degree of condence in causal
relationships than other research designs, thus increasing
such a study’s internal validity.
45-48
Furthermore, the previous literature suggested
that dropout rates can be expected to be less than 15%
to 20% for RCTs.
49
In this review, 7 out of the 9 RCTs
showed dropout rates of <20%, with the reasons and
time of dropping out varying, including during the
intervention (e.g., dead, declined to continue) and during
the study assessment period (e.g., lost to follow-up). e
dropout rate is an essential issue because it can threaten
a study’s’ internal validity (e.g., by changing the random
composition of the groups and their equivalence), external
validity (e.g., by decreasing the generalizability of the RCT
ndings to only those who remained in the study), and
statistical validity (e.g., by diminishing the sample size
and the statistical power to detect dierences between
the intervention and control groups). Accordingly, most
RCTs in this review seemed to have minimized these
threats as acceptable dropout rates were reported.
50,51
However, another 2 RCTs had dropout rates of 39.38%.
28
and 26.32%
31
, so improving the retention rates by following
the appropriate guideline for additional investigation is
required.
Nevertheless, there were also some limitations found
in the included RCTs in this review that need to be noted.
Self-reporting, the generalizability of the ndings, and
study recruitment issues need to be considered. First, 6
of the RCTs used various dierent medication adherence
report scales with the reliability and validity reported,
while the other 3 RCTs used medication adherence report
scales without reporting the reliability and validity. Most
of the included medication adherence reported scales
in this review showed acceptable reliability and validity.
However, most of them involved self-reporting, which is
simple, inexpensive, and practically useful in the clinical
setting, but is subject to certain limitations, such as being
susceptible to errors, with the increase in time between
visits particularly needing to be considered as this can
threaten the study’s internal validity.
52
On the other hand,
Ruksakulpiwat.
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direct methods of measuring medication adherence, such
as measuring medication concentration in the blood or
urine and detecting biological markers in the blood, have
several disadvantages too, such as typically being expensive
and labor-intensive. Nevertheless, in some situations,
this approach is practical; for instance, evaluating the
serum level of antiepileptic drugs (phenytoin, valproic
acid).
52
In summary, there is no gold standard to measure
medication adherence
53,54
, and the choice may depend on
the research objective, funding, study population, and
setting. Researchers need to consider the measurement
carefully, and importantly, any error or bias that threatens
the study validity should be minimized.
Second, the generalizability of the RCTs’ ndings
should also be considered as a limitation since most of
the RCTs were carried out in a specic unit and specic
stroke population. For example, Wan et al.’s study
25
performed RCTs in 3 units of 2 major hospitals, thus
limiting the generalizability of the ndings to the whole
population. Moreover, another study included only
patients diagnosed with mild ischemic stroke, while
severe stroke patients were excluded, which could have
led to selection bias, thus limiting the generalizability of
the results.
27
Finally, study recruitment issues also need to be
mentioned as a limitation of the included RCTs. With
the ongoing development of technology, more people can
now access the internet; however, some people still cannot
or do not. In this regard, one study recruited participants
entirely online
23
, citing literature that indicated that
more than 50% of patients use the internet for medical
information.
23
Hence, the signicant improvement in
medication adherence or other related outcomes in
either the control or intervention group may have been
due to the interventional design itself or extraneous
variables, like information obtained from the internet,
and so this study’s results may not be generalizable
to other populations with dierent sociodemographic
characteristics, such as those who cannot access the
internet.
LIMITATIONS
ere are several limitations in this integrative review
itself to note. First, the researcher searched only the
PubMed electronic database and relevant bibliographies,
which could possibly lead to a limitation of this study’s
ndings and generalizability. Additionally, this review’s
primary purpose was to systematically identify and
analyze reported randomized controlled trials (RCTs) for
interventions aimed at enhancing medication adherence
in stroke patients. erefore, the researcher solely included
RCTs involving a medication adherence intervention.
As it included only one type of study design, this may
lead to a limitation of the research ndings. In any
further study, it is suggested that other types of study
design that involve this kind of intervention should be
included, such as quasi-experimental studies, which may
increase the integrative review’s uniqueness. Moreover,
since the researcher did not include studies from the
“gray” literature, such as conference proceedings or
abstracts, this may introduce a publication bias. Finally,
only English-language studies were included. Because of
this, RCTs reported in other languages that also aimed
to improve medication adherence in stroke patients may
have been missed and hence omitted.
CONCLUSION
Medication adherence can lead to diminished
healthcare service use, improved patient quality of life, and
decreased healthcare expenses.
55-57
e present integrative
review has implications for the heightened recognition
of the necessity of interventions aimed at enhancing
patients’ adherence to their medication, and that could
be applied in clinical practice. For example, there is the
possibility of using medication-taking reminder mobile
applications (such as Medisafe) to improve medication
adherence and clinical outcomes among stroke patients,
yet this innovation has never been used before among
stroke patients. In the future, health care providers may
utilize this innovation to promote high-quality stroke
care in clinical practice. A previous systematic review
revealed that four studies used such a reminder system,
three of which reported a signicant positive impact on
medication adherence.
18
One study into the medication
adherence of HIV patients receiving message reminders
found a signicant dierence in favor of those receiving
message reminders.
18
Likewise, one asthmatic study
found that the adherence rate of asthma patients who
received daily message reminders was higher than those
who were not reminded.
58
erefore, the use of Medisafe
appears to be a potential tool for assisting medication
adherence in patients with stroke, albeit some questions
arise as an outcome of this integrative literature review
related to its use, specically: 1) Can Medisafe improve
medication adherence in stroke patients? 2) Can Medisafe
improve clinical outcomes, such as blood pressure, in
stroke patients?
Funding: is research received no specic grant from
any funding agency in public, commercial, or not-for-
prot sectors.
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Conict of Interests: ere are no conicts of interest
to declare.
Supplementary Material: Supplementary materials
(Supplementary Table 1) related to this article can
be accessed by contacting the corresponding author
(suebsarn25@gmail.com).
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21. Van Dulmen S, Sluijs E, Van Dijk L, De Ridder D, Heerdink R,
Bensing J, et al. Furthering patient adherence: a position paper
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22. Liberati A, Altman D, Tetzla J, Mulrow C, Gøtzsche P, Ioannidis
J, et al. e PRISMA statement for reporting systematic reviews
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23. Morawski K, Ghazinouri R, Krumme A, Lauenburger JC, Lu Z,
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24. Sit JW, Chair SY, Choi KC, Chan CW, Lee DT, Chan AW, et al.
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trial. Clin Interv Aging 2016;11:1441-50.
25. Wan LH, Zhang XP, Mo MM, Xiong XN, Ou CL, You LM,
et al. Eectiveness of Goal-Setting Telephone Follow-Up on
Health Behaviors of Patients with Ischemic Stroke: A Randomized
Controlled Trial. J Stroke Cerebrovasc Dis 2016;25(9):2259-70.
26. Su Q, Li C, Long F, Chen B, Wan Z, Wu Y, et al. Eects of a
health promotion program on medication adherence to antiplatelet
therapy among ischemic stroke patients in Hainan Province,
China. Vascular 2017;25(3):242-8.
27. Wan LH, Zhang XP, You LM, Ruan HF, Chen SX. e Ecacy
of a Comprehensive Reminder System to Improve Health
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McPherson K, et al. Improving Adherence to Secondary
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29. Kamal AK, Khalid W, Muqeet A, Jamil A, Farhat K, Gillani
Ruksakulpiwat.
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30. Kamal AK, Shaikh Q, Pasha O, Azam I, Islam M, Memon AA,
et al. A randomized controlled behavioral intervention trial
to improve medication adherence in adult stroke patients with
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study. BMC Neurol 2015;15:212.
31. Sajatovic M, Tatsuoka C, Welter E, Colon-Zimmermann K,
Blixen C, Perzynski AT, et al. A Targeted Self-Management
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33. Chiaranai C. Patient Reminder Program: An Eective Technology
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34. Wroe AL. Intentional and unintentional nonadherence: a
study of decision making. J Behav Med 2002;25(4):355-72.
35. Odegard PS, Gray SL. Barriers to medication adherence in
poorly controlled diabetes mellitus. Diabetes Educ 2008;34(4):
692-7.
36. Walker EA, Molitch M, Kramer MK, Kahn S, Ma Y, Edelstein S,
et al. Adherence to preventive medications: predictors and
outcomes in the Diabetes Prevention Program. Diabetes Care
2006;29(9):1997-2002.
37. Bartlett JA. Addressing the challenges of adherence. J Acquir
Immune Dec Syndr 2002;29:S2-S10.
38. Roberts KJ. Barriers to and facilitators of HIV-positive patients’
adherence to antiretroviral treatment regimens. AIDS Patient
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39. Wu J-R, Moser DK, Lennie TA, Burkhart PV. Medication
adherence in patients who have heart failure: a review of the
literature. Nurs Clin North Am 2008;43(1):133-53.
40. Nair KV, Belletti DA, Doyle JJ, Allen RR, McQueen RB, Saseen
JJ, et al. Understanding barriers to medication adherence in
the hypertensive population by evaluating responses to a
telephone survey. Patient Prefer Adherence 2011;5:195.
41. Oltho CM, Hoevenaars JG, van den Borne BW, Webers CA,
Schouten JS. Prevalence and determinants of non-adherence to
topical hypotensive treatment in Dutch glaucoma patients.
Graefes Arch Clin Exp Ophthalmol 2009;247(2):235.
42. Bregnballe V, Schiøtz PO, Boisen KA, Pressler T, astum M.
Barriers to adherence in adolescents and young adults with
cystic brosis: a questionnaire study in young patients and
their parents. Patient Prefer Adherence 2011;5:507.
43. Lawson EF, Hersh AO, Applebaum MA, Yelin EH, Okumura
MJ, von Scheven E. Self-management skills in adolescents
with chronic rheumatic disease: a cross-sectional survey.
Pediatr Rheumatol Online J 2011;9(1):35.
44. Zelikovsky N, Schast AP, Palmer J, Meyers KE. Perceived
barriers to adherence among adolescent renal transplant
candidates. Pediatr Transplant 2008;12(3):300-8.
45. Kamal AK, Shaikh QN, Pasha O, Azam I, Islam M, Memon
AA, et al. Improving medication adherence in stroke patients
through Short Text Messages (SMS4Stroke)-study protocol
for a randomized, controlled trial. BMC Neurol 2015;15(1):157.
46. Kendall J. Designing a research project: randomised controlled
trials and their principles. EMJ. 2003;20(2):164.
47. Chan A-W, Tetzla JM, Gøtzsche PC, Altman DG, Mann H,
Berlin JA, et al. SPIRIT 2013 explanation and elaboration:
guidance for protocols of clinical trials. BMJ (Clinical research
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48. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC,
Devereaux P, et al. CONSORT 2010 explanation and elaboration:
updated guidelines for reporting parallel group randomised
trials. Int J Surg 2012;10(1):28-55.
49. Cramer H, Haller H, Dobos G, Lauche R. A systematic review
and meta-analysis estimating the expected dropout rates in
randomized controlled trials on yoga interventions. Evid Based
Complement Alternat Med 2016;2016.
50. Dixon LJ, Linardon J. A systematic review and meta-analysis
of dropout rates from dialectical behaviour therapy in randomized
controlled trials. Cogn Behav er 2020;49(3):181-96.
51. Higgins JP, omas J, Chandler J, Cumpston M, Li T, Page MJ,
et al. Cochrane handbook for systematic reviews of interventions.
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53. Wagner J, Justice A, Chesney M, Sinclair G, Weissman S,
Rodriguez-Barradas M. Patient-and provider-reported adherence:
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54. Alcoba M, Cuevas MJ, Perez-Simon M-R, Mostaza J-L, Ortega L,
de Urbina JO, et al. Assessment of adherence to triple antiretroviral
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levels of indinavir. J Acquir Immune Dec Syndr 2003;33(2):
253-8.
55. Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact
of medication adherence on hospitalization risk and healthcare
cost. Med Care 2005:521-30.
56. Simpson SH, Eurich DT, Majumdar SR, Padwal RS, Tsuyuki
RT, Varney J, et al. A meta-analysis of the association between
adherence to drug therapy and mortality. BMJ 2006;333(7557):15.
57. Roebuck MC, Liberman JN, Gemmill-Toyama M, Brennan TA.
Medication adherence leads to lower health care use and costs
despite increased drug spending. Health A (Millwood) 2011;
30(1):91-9.
58. Strandbygaard U, omsen SF, Backer V. A daily SMS reminder
increases adherence to asthma treatment: a three-month
follow-up study. Respir Med 2010;104(2):166-71.
Volume 73, No.3: 2021 Siriraj Medical Journal
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438
SUPPLEMENTARY TABLE 1. e literature review paper matrix.
References, Target
Problem & Theoretical
Medication Methodological
countries, population,
Purpose Framework
Intervention details adherence measures problems: Threats Key Findings Implications
and duration sample size (reliability, validity) to study validity
of RCTs (n)* (Critical Analysis)
(1)
1
The United
States
3 months
(2)
2
The United
States
6 months
Hypertensive
Experimental
(E): 209
Control (C): 202
Note: the author
included
hypertensive
patients because
it is the most
relevant study;
Medisafe never
used in stroke
patients.
- Dropout rate
of 12%
Ischemic stroke,
Hemorrhagic
stroke
E: 105
C: 105
- Dropout rate
of 16.7%
- Medication non-
adherence estimates
for 50% of uncon-
trolled hypertension.
Smartphone
applications (apps)
that aim to improve
adherence are
broadly available but
have not been
rigorously evaluated.
- This study aimed
to determine if the
Medisafe smartphone
application increases
self-reported
medication adherence
and blood pressure
control.
- After a stroke,
self-management is
a challenge because
of multifaceted care
needs and complex
disabling consequences
that further barrier
patient participation.
Unspecied
(Study
protocol
provided)
- The theory
of health
empowerment
- Self-efcacy
Theory
E: In this group,
participants were guided
to download and use the
Medisafe application,
including medication-
taking reminder alerts,
adherence reports, and
optional peer support.
C: N/A
Randomly assigned
The author attempted to
enroll at least 390 patients
to have 80% power to
detect a 5 mmHg. the
difference in systolic blood
pressure between
treatment arms, with an
α of 0.05 (even with a
20% loss to follow up or a
standard deviation of up to
17 mm Hg)
E: Usual care (the
ambulatory rehabilitation
schedule) + small group
sessions (establish a
partnership with the nurse
facilitator for stroke self-
management to begin
personal goal setting and
action planning) +
The 8-item Morisky
medication adherence
scale (MMAS-8)
Reliability:
Chronbach's alpha
0.83
Validity:
(93% sensitivity,
53% specicity)
The 4-item Morisky
medication adherence
scale (MMAS-4)
Reliability: Chronbach's
alpha 0.55
Average item-test
correlations: 0.65
- The recruitment was per-
formed entirely online, in
which the literature showed
that more than 50% of pa-
tients use the internet for
medical information. These
RCT results may not be
generalizable to other
populations of individuals
with poorly controlled hy-
pertension, who may have
different sociodemographic
and comorbidity character-
istics than the patients in
our study participants.
- The researcher used
home blood pressure
monitors to evaluate blood
pressure outcomes, in
which different participant
may measure their blood
pressure differently. This
can threaten internal
validity (measurement).
- Self-management
behavior was assessed
using self-report. This
might have led to over-
reporting of what was seen
as desired behavior by the
participants.
- The baseline
characteristics between
- After 12 weeks, the
mean (SD) score on the
MMAS improved by 0.4
(1.5) among intervention
participants and remained
unchanged among controls
(between-group difference:
0.4; 95% CI, 0.1-0.7; P =
0.01). ˄
- After 12 weeks, the mean
(SD) systolic blood
pressure decreased by 10.6
(16.0) mm Hg among
intervention participants
and 10.1 (15.4) mm Hg
among controls (between-
group difference: −0.5; 95%
CI, −3.7 to 2.7; P = 0.78). ≠
- Medication adherence. ≠
- Self-efcacy in illness
management 3-month and
6-month. ˄
- Self-management
behaviors at all follow-up
time points. ˄
- Patients randomized
to use a smartphone
application had a small
improvement in self-
reported medication
adherence among
poorly controlled
hypertension patients
but no change in
systolic blood pressure
than controls. Hence,
its advantage and
other mobile health
interventions on clinical
outcomes remain to be
established.
- The recruitment
method should be
improved.
- The way of blood
pressure measuring
should be improved.
Stroke patient
empowerment
intervention could be
combined into the
ambulatory rehabilitation
phase. It would
become more plausible
for continuing
professional support
Ruksakulpiwat.
Original Article
SMJ
Volume 73, No.3: 2021 Siriraj Medical Journal
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439
SUPPLEMENTARY TABLE 1. e literature review paper matrix. (Continue)
(3)
3
China
6 months
Ischemic stroke
E: 40
C: 40
- Dropout rate
of 12.1%
- This study aimed
to investigate the
effects of the Health
Empowerment
Intervention for
Stroke Self-manage-
ment (HEISS) on
stroke patients'
self-efcacy, self-
management
behavior, and
functional recovery.
- Adopting healthy
behaviors is critical
for secondary stroke
prevention. However,
compliance often
decreases with time
after hospital
discharge, yet few
studies have
investigated programs
promoting long-term
adherence to health
behaviors.
- This research
proposed to evaluate
the effectiveness of
a guideline-based,
goal-setting telephone
follow-up program for
patients with ischemic
stroke.
Guidelines
for the
Secondary
Prevention
of Ischemic
Stroke and
Transient
Ischemic
Attack
biweekly telephone
follow-up calls (encourage
and commend participants
on their actions for positive
changes and to provide
problem-solving skills to
overcome any perceived
barriers that participants
encountered).
C: Usual care only.
Randomly assigned
E: The intervention group
consisted of predischarge
education and three
goal-setting follow-up
sessions conducted by
telephone.
C: The control group
gained the usual stroke
education, including freely
available educational
brochures on
understanding stroke and
cutting stroke risk.
Randomly assigned
(internal consistency
reliability)
Validity: good
sensitivity and
moderate specicity in
identifying nonadherent
individuals
Modied health
behavior scale
Content validity
index: 0.85
Cronbach’s α
(reliability): 0.878
The split-half
reliability: 0.801
(a measure of internal
consistency — how
well the test
components contribute
to the construct that's
being measured)
those who have completed
data collection and those
who have dropped-out
were nearly similar.
The intervention's effects
might be overestimated
if dropped out cases had
better outcome measures
or vice versa.
- The information
regarding health behaviors
and medication adherence
was self-reported, so
memory errors and
expectation bias may have
inuenced the result.
- The study was carried
in 3 units of 2 major
hospitals, limiting the
generalizability of ndings
to the whole population.
- Eleven patients
meeting the inclusion
criteria declined to
participate, suggesting that
better recruitment methods
are expected.
- Six months after
discharge, patients in the
intervention group
exhibited signicantly
higher medication
adherence than patients
in the control group. ˄
- Physical activity, nutrition,
low-salt diet adherence,
blood pressure monitoring,
smoking abstinence,
unhealthy alcohol use,
and modied Rankin Scale
(mRS). ≠
to aid stroke patients
in understanding
responsibility for and
participating in stroke
self-management in a
home setting.
The intervention
improved only
medication adherence
at six months post-
discharge. These
results indicate a
need for more
effective strategies to
help stroke patients
achieve guideline-
recommended targets
for health behaviors
References, Target
Problem & Theoretical
Medication Methodological
countries, population,
Purpose Framework
Intervention details adherence measures problems: Threats Key Findings Implications
and duration sample size (reliability, validity) to study validity
of RCTs (n)* (Critical Analysis)
Volume 73, No.3: 2021 Siriraj Medical Journal
https://he02.tci-thaijo.org/index.php/sirirajmedj/index
440
SUPPLEMENTARY TABLE 1. e literature review paper matrix. (Continue)
(4)
4
China
1 year
(5)
5
China
3 months
Ischemic stroke
E: 613
C: 574
- Dropout rate
of 6.9%
Ischemic stroke
E: 80
C: 78
- Dropout rate
of 9.2%
- Antiplatelet is the
treatment of the rst
choice for long-term
secondary prevention
of vascular events.
Although ischemic
stroke patients are
still at signicant
risk for recurrence;
roughly one-third
of stroke survivors
will have a recurrent
vascular event within
ve years.
- This RCT proposes
to evaluate a health
promotion program
on medication
adherence to
antiplatelet therapy
among ischemic
stroke patients.
- The health behaviors
of hypertensive stroke
patients in China
are not satisfactory.
Because unimodal
programs were
inefcient for improving
blood pressure
control in stroke
patients, recent efforts
are directed at multi-
modal interventions.
Guidelines
for the
Secondary
Prevention
of Ischemic
Stroke and
Transient
Ischemic
Attack
Health
Belief Model
E: The daily 30 minutes of
training sessions for three
days aimed to develop
patients' awareness and
improve their medication
adherence. The physicians
called the patients at one,
three, and six months
after hospital discharge
to monitor progress and
offer secondary prevention
guidance.
C: Usual stroke
management programs.
Randomly assigned
E: Usual care + face-to-
face and telephone health
belief education, a patient
calendar handbook, and
weekly automated short-
message services.
C: Usual care only
(health education during
hospitalization, a stroke
prevention handout,
follow-up by doctors
The proportion of
medication-taking was
compared between the
control and intervention
groups.
Reliability: N/A
Validity: N/A
The Health Promoting
Lifestyle Prole II
Cronbach’s α
(reliability): 0.853
The split-half
reliability: 0.781
Test-retest reliability:
0.845
- The data collected are
self-reported; participants
likely over or underrated
their skills and knowledge
when responding to
survey items.
- No reliability and
validity of medication
adherence measurement
were reported.
- The program is
considered proper only
for patients diagnosed
with mild ischemic stroke.
Severe stroke patients
were excluded; this can
lead to selection bias.
- Health behavior informa-
tion was self-reported and
subject to expectation bias
(Hawthorne effect).
- After a one-year follow-up,
the proportion of patients
who took the antiplatelet
therapy increased
signicantly in the
intervention group,
reaching 73.2%, with a
pre-post difference be-
tween two arms of 22.9%
(P < 0.01). ˄
- The proportion of patients
with an awareness of
antiplatelet therapy
signicantly increase
(24.4%, P < 0.01). ˄
- Medication adherence. ˄
- Better health behaviors
for physical activity,
nutrition, low-salt diet. ˄
- Decreased systolic blood
pressure and increased
blood pressure control
rate. ˄
The health
promotion program
showed a positive
impact on awareness
of and adherence to
antiplatelet therapy,
which can be scaled
up to other
resource-limited areas.
At three months,
the Comprehensive
Reminder System's
use based on the
Health Belief Model
produced a positive
outcome of most
health behaviors and
blood pressure control.
Continued
implementation of this
intervention protocol
Ruksakulpiwat.
References, Target
Problem & Theoretical
Medication Methodological
countries, population,
Purpose Framework
Intervention details adherence measures problems: Threats Key Findings Implications
and duration sample size (reliability, validity) to study validity
of RCTs (n)* (Critical Analysis)
Original Article
SMJ
Volume 73, No.3: 2021 Siriraj Medical Journal
https://he02.tci-thaijo.org/index.php/sirirajmedj/index
441
SUPPLEMENTARY TABLE 1. e literature review paper matrix. (Continue)
(6)
6
New Zealand
12 months
Unspecied
(excluding
subarachnoid
hemorrhage)
E: 119
C: 115
- Dropout rate
of 39.38%
- This study aimed
to test the effect of a
Health Belief Model
Comprehensive
Reminder System
on health behaviors
and blood pressure
control in
hypertensive ischemic
stroke patients after
the occurrence and
hospital discharge.
- The literature shows
that stroke recurrence
rates are high
(20%–25%) and have
not declined over the
past three decades.
- This study aimed
to examine the
effectiveness of
motivational
interviewing (MI)
for reducing stroke
recurrence.
Medication adherence
and lifestyle change
will be measured.
Unspecied
at the outpatient
department, and telephone
follow-up by nurses at one
week and one month after
discharge).
Randomly assigned
E: The intervention group
received four motivational
interview sessions at 28
days, 3, 6, and 9 months
post-stroke. Sessions
were audio-recorded.
The primary interview was
administered face-to-face;
subsequent interviews
were conducted by
telephone.
C: Usual care only.
Randomly assigned
- Asking whether (in the
past seven days) they
had taken all of their
medication as pre-
scribed.
- Patients were asked
to indicate the number
of doses/pills missed,
if they just forgot (yes/
no), the reason for the
missed dose(s), and
to provide detail if side
effects were noted.
Reliability: N/A
Validity: The validity of
self-reports was cross-
checked with electronic
medication dispense
records where available,
which suggests accurate
reporting.
- Although medication
adherence measured by
self-reports is inexpensive
and straightforward, and
validated for use in clinical
settings, it may have led
to an overestimation of
adherence.
- The motivational
interview's nature was
not plausible to blind
participants, which may
have inuenced self-report
outcomes.
- Self-reported
medication adherence
at six months and nine
months post-stroke. ˄
- The change measures
blood pressure and
cholesterol. ≠
is guaranteed to
determine the
long-term effect.
Motivational interview
(MI) developed self-
reported medication
adherence. Other
effects were
nonsignicant, though
in the direction of
a treatment effect.
Additional research is
required to determine
whether MI leads to
improvement in other
essential functioning
(e.g., caregiver
burden).
References, Target
Problem & Theoretical
Medication Methodological
countries, population,
Purpose Framework
Intervention details adherence measures problems: Threats Key Findings Implications
and duration sample size (reliability, validity) to study validity
of RCTs (n)* (Critical Analysis)
Volume 73, No.3: 2021 Siriraj Medical Journal
https://he02.tci-thaijo.org/index.php/sirirajmedj/index
442
SUPPLEMENTARY TABLE 1. e literature review paper matrix. (Continue)
(7)
7
Pakistan
3 months
Unspecied
(stroke) +
coronary artery
disease
E: 99
C: 98
- Dropout rate
of 9.64%
- Medications can
diminish stroke risk
by 30% and
Myocardial Infarction
(MI) by 15%.
Nevertheless,
adherence, even in
developed countries,
is only around 50%.
Health-based
procedures can be an
inexpensive and
efciently accessible
tool to increase
compliance and
bridge the
communication gap
between health care
providers and users.
- This RCT aimed to
develop and examined
the effectiveness of
a tailored health
information
technology-driven
intervention: "Talking
Prescriptions" to
increase medication
adherence in
patients.
Unspecied E: This group received
daily Interactive Voice
Response (IVR) call
services regarding spe-
cic statin and antiplatelet,
daily tailored medication
reminders for statin and
antiplatelet, and weekly
lifestyle modication mes-
sages.
C: N/A
Randomly assigned
The 8-item Morisky
medication adherence
scale (MMAS-8)
Reliability: (α = 0.83)
Validity: (93%
sensitivity, 53%
specicity)
- Medication adherence
was assessed using self-
report; this might have led
to overreporting.
- This RCT did not study
the effect of an intervention
on improving patient
clinical outcomes targeted
for future larger-scale
clinical trials.
The 8-item Morisky
medication adherence
scale. ≠
A phone-based
medication adherence
program was possible
in settings with high
volume clinics and
low patient
knowledgeability.
Due to limited
follow-up, the program
did not achieve any
statistically signicant
differences in
adherence behavior
as self—reported by
the MMAS-8 Scale.
Ruksakulpiwat.
References, Target
Problem & Theoretical
Medication Methodological
countries, population,
Purpose Framework
Intervention details adherence measures problems: Threats Key Findings Implications
and duration sample size (reliability, validity) to study validity
of RCTs (n)* (Critical Analysis)
Original Article
SMJ
Volume 73, No.3: 2021 Siriraj Medical Journal
https://he02.tci-thaijo.org/index.php/sirirajmedj/index
443
SUPPLEMENTARY TABLE 1. e literature review paper matrix. (Continue)
(8)
8
Pakistan
2 months
(9)
9
The United
States
6 months
Ischemic stroke
E: 83
C: 79
- Dropout rate
of 19%
Unspecied
(stroke) +
Transient
Ischemic Attack
E: 14
C: 14
- Dropout rate
of 26.32%
- Mobile technology's
effectiveness in
improving medication
adherence via
customized Short
Messaging Service
(SMS) reminders for
stroke has not been
tested in low resource
areas.
- This study aimed to
test the effectiveness
of SMS on developing
medication adherence
in stroke survivors.
- Stroke is the leading
cause of disability,
death, and health
resource use among
Americans. Self-
management is a
caring procedure that
allows individuals to
solve problems as
they arise, practice
new health behaviors,
and gain emotional
stability. Although
several articles support
self-management
training for stroke
survivors, there is
limited data specic
to young African
Americans men.
- Health Belief
Model
- Social
Cognitive
Theory
Unspecied
E: Usual care +
received reminder SMS
for two months that
contained personalized,
prescription tailored daily
medication reminder(s),
and twice-weekly health
information SMS.
C: Usual care only.
Randomly assigned
E: Participants obtain
self-management training,
delivered in 1 individual
and 4 group sessions
(over three months).
C: Usual care only.
Randomly assigned
The 8-item Morisky
medication adherence
scale (MMAS-8)
Reliability: (α = 0.83)
Validity: (93%
sensitivity, 53%
specicity)
The Tablets Routines
Questionnaire (TRQ)
Reliability: N/A
Validity: N/A
- Medication adherence
was assessed using
self-report; this might
have led to overreporting.
- Participants who only
have a telephone can
participate in this study.
Those who do not have
may underrepresent, and
this leads to selection
bias.
- Small sample size,
limited duration, and
research staff were not
blind to the intervention
assignment.
- Using a one-time
blood pressure
assessment, including
the possibility of elevation
when a measurement is
done in a clinical setting
(white-coat hypertension)
and underdetection
(masked hypertension).
- The mean medication
adherence score ˄
- The mean diastolic blood
pressure ˄
- Medication adherence ≠
- High-density lipoprotein
cholesterol ˄
- Glycosylated
hemoglobin ˄
- Systolic blood pressure ˄
The SMS intervention
seems possible for
clinical use in stroke
survivors for improving
adherence. Further
investigations are
needed to report on
meaningful biologic
outcomes like
recurrent stroke,
death, and disability.
The intervention was
not capable of
engaging all patients.
Qualitative ndings
suggest that while
the group format was
highly acceptable,
aspects of the program
might be improved.
More sessions might
have been
accommodating,
supporting telephone
attendance for those
with travel or logistic
difculties.
References, Target
Problem & Theoretical
Medication Methodological
countries, population,
Purpose Framework
Intervention details adherence measures problems: Threats Key Findings Implications
and duration sample size (reliability, validity) to study validity
of RCTs (n)* (Critical Analysis)
Volume 73, No.3: 2021 Siriraj Medical Journal
https://he02.tci-thaijo.org/index.php/sirirajmedj/index
444
SUPPLEMENTARY TABLE 1. e literature review paper matrix. (Continue)
- This study
proposed to compare
a self-management
intervention
(TargetEd
MAnageMent
Intervention [TEAM])
versus treatment as
usual (TAU) to reduce
stroke risk in African
American (AA) men.
RCTs Randomized Controlled Trials
N/A Not applicable
*Final analyzed
˄
Outcome signicantly improved aer the intervention
˅
Outcome signicantly worsened aer the intervention
≠ Outcome unchanged aer the intervention
REFERENCES
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2. Sit JW, Chair SY, Choi KC, et al. Do empowered stroke patients perform better at self-
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7. Kamal AK, Khalid W, Muqeet A, et al. Making prescriptions "talk" to stroke and heart attack
survivors to improve adherence: Results of a randomized clinical trial (e Talking Rx Study).
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8. Kamal AK, Shaikh Q, Pasha O, et al. A randomized controlled behavioral intervention trial to
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9. Sajatovic M, Tatsuoka C, Welter E, et al. A Targeted Self-Management Approach for Reducing
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Ruksakulpiwat.
References, Target
Problem & Theoretical
Medication Methodological
countries, population,
Purpose Framework
Intervention details adherence measures problems: Threats Key Findings Implications
and duration sample size (reliability, validity) to study validity
of RCTs (n)* (Critical Analysis)
