ANZCTR - Registration

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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]

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

Condition category

Condition code

Stroke

Ischaemic

Stroke

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]

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]

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]

Timepoint: Baseline, 1st, 3rd,6th and 12th month of study duration.

Primary outcome [2]

Recurrent stroke events.

Timepoint [2]

Baseline, 1st,3rd,6th and 12th month of study duration.

Secondary outcome [1]

Secondary outcome 1: changes in medication adherence using validated (MARS) medication adherence rating scale

Timepoint [1]

Baseline, 1st, 3rd,6th and 12th month of study duration

Secondary outcome [2]

Secondary outcome 2: changes in stroke knowledge using validated (SKT) stroke knowledge test

Timepoint [2]

Baseline, 1st, 3rd,6th and 12th month of study duration

Secondary outcome [3]

Secondary outcome 3: changes in belief about medicine using validated (BMQ) belief about medicine questionnaire

Timepoint [3]

Baseline, 1st, 3rd,6th and 12th month of study duration

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

19/03/2018

Actual

Date of last participant enrolment

Anticipated

19/06/2018

Actual

Date of last data collection

Anticipated

19/06/2019

Actual

Sample size

Target

240

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Klang Valley

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Medicine and Health Sciences, Monash University, Malaysia

Address [1]

Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

MEDICAL RESEARCH AND ETHICS COMMITTEE (MREC)

Ethics committee address [1]

Secretariat of National Institutes of Health (NIHSEC)
c/o Institute for Health Management
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

08/05/2017

Approval date [1]

07/07/2017

Ethics approval number [1]

NMRR-15-851-24737

Ethics committee name [2]

Monash University Human Research Ethics Committee (MUHREC)

Ethics committee address [2]

Wellington Rd, Clayton VIC 3800, Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

29/05/2017

Approval date [2]

12/06/2017

Ethics approval number [2]

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

Ms Jamunarani Appalasamy

Address

School of Medicine and Health Sciences, Monash University, Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia

Country

Malaysia

Phone

+60123253775

Fax

jhamunaa2@gmail.com

Contact person for public queries

Name

Jamunarani Appalasamy

Address

School of Medicine and Health Sciences, Monash University, Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia

Country

Malaysia

Phone

+60123253775

Fax

jamuna.appalasamy@monash.edu

Contact person for scientific queries

Name

Jamunarani Appalasamy

Address

School of Medicine and Health Sciences, Monash University, Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia

Country

Malaysia

Phone

+60123253775

Fax

jamuna.appalasamy@monash.edu

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effectiveness of culturally tailored video narratives on medication understanding and use self-efficacy among stroke patients.	2018	https://dx.doi.org/10.1097/MD.0000000000010876
Embase	An evaluation of the video narrative technique on the self-efficacy of medication understanding and use among post-stroke patients: A randomized-controlled trial.	2020	https://dx.doi.org/10.2147/PPA.S253918

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically