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Trial registered on ANZCTR


Registration number
ACTRN12618000174280
Ethics application status
Approved
Date submitted
25/09/2017
Date registered
5/02/2018
Date last updated
7/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effectiveness of video narratives on medication understanding and use self-efficacy among stroke patients
Scientific title
Investigating the effectiveness of health belief constructs incorporated as video narratives on medication understanding and use self-efficacy among stroke patients.
Secondary ID [1] 292762 0
None
Universal Trial Number (UTN)
U1111-1201-3955
Trial acronym
MyStrokeStory
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Stroke 304555 0
Condition category
Condition code
Stroke 303879 303879 0 0
Ischaemic
Stroke 303880 303880 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized controlled trial between 2 groups ( 1 control arm and 1 intervention arms) which would like to evaluate the effectiveness of narrative videos about patient and doctor stories influencing medication understanding and use self-efficacy among stroke patients. The informed and consented patients would be selected according to inclusion and exclusion criteria and follow randomization process.
The control arm receives the usual care treatment by the hospital healthcare providers and written information about recurrent stroke, and it's medication management whereas the intervention arm receives standard care treatment, written information about recurrent stroke and its management and a video narrative from a neurologist and patient story in Malay or English. The video from a neurologist provides his point of view regarding stroke patients. Whereas the videos of a stroke patient depict his illness story and how he overcomes his challenges. Further queries regarding their medication or treatment would be documented and would be politely informed to refer to their physicians and hospital management to maintain internal validity. This intervention aims to enhance self-efficacy via health belief constructs and self-empowerment characteristics to control stroke risk factors leading to recurrent stroke.
The videos would be shown personally using a tablet or mobile device by the researcher himself at baseline, 1st, 3rd and 6th month of study during clinic hours only. Whereby outcome measures are done 1st, 3rd, 6th and 12th month. A 6 month non intervention as retention period would be applied to evaluate sustainability of intervention. The videos would not be shared online to maintain external validity.
Intervention code [1] 299206 0
Treatment: Other
Comparator / control treatment
The intervention has been modified to a narrative video from a healthcare provider and patients. The patients are randomized to control arm (receiving no videos), intervention arm (receiving a narrative video).
Control group
Active

Outcomes
Primary outcome [1] 303489 0
Primary outcome: changes in medication understanding and use self-efficacy measured using validated MUSE (medication understanding and use self-efficacy questionnaire). This is a composite primary outcome.
Timepoint [1] 303489 0
Timepoint: Baseline, 1st, 3rd,6th and 12th month of study duration.
Primary outcome [2] 304495 0
Recurrent stroke events.
Timepoint [2] 304495 0
Baseline, 1st,3rd,6th and 12th month of study duration.
Secondary outcome [1] 339060 0
Secondary outcome 1: changes in medication adherence using validated (MARS) medication adherence rating scale


Timepoint [1] 339060 0
Baseline, 1st, 3rd,6th and 12th month of study duration
Secondary outcome [2] 339061 0
Secondary outcome 2: changes in stroke knowledge using validated (SKT) stroke knowledge test
Timepoint [2] 339061 0
Baseline, 1st, 3rd,6th and 12th month of study duration
Secondary outcome [3] 339062 0
Secondary outcome 3: changes in belief about medicine using validated (BMQ) belief about medicine questionnaire
Timepoint [3] 339062 0
Baseline, 1st, 3rd,6th and 12th month of study duration
Secondary outcome [4] 339063 0
Secondary outcome 4: Stroke risk factor blood parameter control (blood pressure, fasting serum glucose, total cholestrol, INR), This is a composite secondary outcome.
Timepoint [4] 339063 0
Baseline, 1st, 3rd,6th and 12th month of study duration

Eligibility
Key inclusion criteria
Inclusion criteria
1) Patient with definitive diagnosis of stroke (MRI/MRA,CT, CT angiography- confirmed diagnosis by neurologist).
2) Patient aged 18 years and above
3.Patient on antithrombotics and any stroke preventative medications (e.g. statins, hyperglycaemic agents, antihypertensive agents.
4) Patients who are able to converse, read and write in Malay or English.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1) Patient with stroke due to accident, external or unexplained causes.
2) Patient with cognitive impairment and/or disorientation (MMSE score < 24)
3) Patient who depends help from caregivers to take their medications.
4) Patient with anxiety and/or depression (PHQ-9 score > 4)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An allocator generates sequence concealed in opaque white envelopes for the executer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization technique with randomly mixed block sizes of two, four, and six.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
a)Based on a similar setting from previous study, mean adherence score with Morisky Medication Adherence Scale was estimated to be 6 in the control group and 7 in the intervention group, giving a mean difference of 1 (SD = 2). Using these values, a sample of at least 170 subjects was required.

Therefore, based on potential outcome measures, the required sample size 170 patients are taken into consideration to achieve a power of 90 % and significance level of 5 % when testing a two tailed hypothesis of inequality of means. Keeping a 15 % attrition rate the sample size was inflated so at least 100 patients were needed in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9229 0
Malaysia
State/province [1] 9229 0
Klang Valley

Funding & Sponsors
Funding source category [1] 297396 0
University
Name [1] 297396 0
School of Medicine and Health Sciences, Monash University, Malaysia
Address [1] 297396 0
Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor
Country [1] 297396 0
Malaysia
Primary sponsor type
University
Name
School of Medicine and Health Sciences, Monash University, Malaysia
Address
Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor
Country
Malaysia
Secondary sponsor category [1] 297582 0
None
Name [1] 297582 0
None
Address [1] 297582 0
None
Country [1] 297582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298495 0
MEDICAL RESEARCH AND ETHICS COMMITTEE (MREC)
Ethics committee address [1] 298495 0
Secretariat of National Institutes of Health (NIHSEC)
c/o Institute for Health Management
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur
Ethics committee country [1] 298495 0
Malaysia
Date submitted for ethics approval [1] 298495 0
08/05/2017
Approval date [1] 298495 0
07/07/2017
Ethics approval number [1] 298495 0
NMRR-15-851-24737
Ethics committee name [2] 298690 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 298690 0
Wellington Rd, Clayton VIC 3800, Australia
Ethics committee country [2] 298690 0
Australia
Date submitted for ethics approval [2] 298690 0
29/05/2017
Approval date [2] 298690 0
12/06/2017
Ethics approval number [2] 298690 0
Monash University Human Research Ethics Committee (MUHREC), Australia – (ID 9640)

Summary
Brief summary
The National Health and Morbidity Survey (NHMS) in 2011, estimated prevalence of stroke was 0.3% among Malaysians. However, stroke patients who are Asians such as Malaysians, were reported to be generally younger whereby stroke onset for Malaysians were with the mean age of 41.5±8.8 years. Up to 35% of all people who experience a transient ischemic attack (TIA, or mini-stroke) will proceed to another stroke within weeks or months. In Malaysia, an estimated of 40,000 acute stroke cases are recorded yearly and a history of stroke or TIA hospitalization contributed 23% of the risk factors to a recurrent stroke. A recent study reported that 38% of non-adherence to prescribed medications contributed to the prevalence of stroke in Malaysia. There were some effort done by Malaysian government to encourage community responsiveness to detect stroke symptoms and enhance awareness to a stroke patient’s need such as FAST acronym and website of stroke information based on Malaysian perspectives. However there is still a need to control stroke risk factors to reduce stroke burden in Malaysia. A summary of a few studies suggested that illness perceptions, knowledge and awareness, treatment beliefs, attitude are linked to self-efficacy which is a predictor to medication taking behavior such as understanding and using medication. In addition, a personalized treatment warrants a better disease management outcome which involve active communication and behavioral changes additional to counseling session were found to be more promising compared to the conventional practice with only patient education and counseling. However, these studies have shown mixed significant results which involved various style of delivery and facilities which varied across culture, setting, sample and study outcomes. Hence, this is the first study in Malaysia which would be observing the possibilities of patient care led by interactive videos emphasizing on personalized learning and guided by healthcare providers. The alternate hypothesis: There is a significant improvement of medication understanding and use self-efficacy observed in the intervention group who was given a personalized video intervention. The null hypothesis: There is no significant improvement of medication understanding and use self-efficacy observed in the intervention group who was given a personalized intervention.



Trial website
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 77274 0
Ms Jamunarani Appalasamy
Address 77274 0
School of Medicine and Health Sciences, Monash University, Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia
Country 77274 0
Malaysia
Phone 77274 0
+60123253775
Fax 77274 0
Email 77274 0
jhamunaa2@gmail.com
Contact person for public queries
Name 77275 0
Ms Jamunarani Appalasamy
Address 77275 0
School of Medicine and Health Sciences, Monash University, Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia
Country 77275 0
Malaysia
Phone 77275 0
+60123253775
Fax 77275 0
Email 77275 0
jamuna.appalasamy@monash.edu
Contact person for scientific queries
Name 77276 0
Ms Jamunarani Appalasamy
Address 77276 0
School of Medicine and Health Sciences, Monash University, Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia
Country 77276 0
Malaysia
Phone 77276 0
+60123253775
Fax 77276 0
Email 77276 0
jamuna.appalasamy@monash.edu

No information has been provided regarding IPD availability
Summary results
No Results