Investigating the effectiveness of video narratives on medication understanding and use self-efficacy among stroke patients

• Register: ANZCTR
• Last refreshed on: 12 November 2018
• Main ID: ACTRN12618000174280
• Date of registration: 05/02/2018
• Prospective Registration: Yes
• Primary sponsor: School of Medicine and Health Sciences, Monash University, Malaysia
• 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.
• Date of first enrolment: 19/03/2018
• Target sample size: 240
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12618000174280.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Malaysia

Contacts

• Name: Ms Jamunarani Appalasamy

• Name: Ms Jamunarani Appalasamy

Key inclusion & exclusion criteria

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.

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)

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Stroke;
Stroke

Stroke - Haemorrhagic

Stroke - Ischaemic

Intervention(s)

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.

Primary Outcome(s)

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

Recurrent stroke events.
[Baseline, 1st,3rd,6th and 12th month of study duration.
]

Secondary Outcome(s)

Secondary outcome 4: Stroke risk factor blood parameter control (blood pressure, fasting serum glucose, total cholestrol, INR), This is a composite secondary outcome.
[Baseline, 1st, 3rd,6th and 12th month of study duration]

Secondary outcome 2: changes in stroke knowledge using validated (SKT) stroke knowledge test[ Baseline, 1st, 3rd,6th and 12th month of study duration
]

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


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

Secondary outcome 3: changes in belief about medicine using validated (BMQ) belief about medicine questionnaire[ Baseline, 1st, 3rd,6th and 12th month of study duration
]

Secondary ID(s)

None

Source(s) of Monetary Support

School of Medicine and Health Sciences, Monash University, Malaysia

Ethics review

Status: Approved
Approval date:
Contact:

MEDICAL RESEARCH AND ETHICS COMMITTEE (MREC)

Status: Approved
Approval date:
Contact:

Monash University Human Research Ethics Committee (MUHREC)