ISupport-Malaysia: an Online Psychoeducational Intervention Program for Informal Dementia Caregivers in Malaysia - a Pilot Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sunway University
- Enrollment
- 70
- Locations
- 4
- Primary Endpoint
- Recruitment Feasibility
Study Overview
Brief Summary
The general objective of this pilot feasibility study is to implement the pilot randomised controlled trial (RCT) and evaluate the feasibility of its methods and procedures for iSupport-Malaysia intervention. Another objective is to assess the acceptability and preliminary impacts of the iSupport-Malaysia web-based intervention on the psychological well-being of informal caregivers (ICs) of persons living with dementia (PLWDs) in Malaysia, compared to iSupport-Malaysia eBook.
The main questions this pilot study aims to answer are:
- How feasible is it to implement iSupport-Malaysia as an accessible resource for ICs of PLWD in Malaysia?
- Does the use of iSupport-Malaysia lead to a reduction in caregiver burden among the ICs of PLWD in both web and eBook conditions?
- Does the use of iSupport-Malaysia lead to improvements in psychological well-being (e.g. reduced depression, anxiety, stress; and increased quality of life) among the ICs of PLWD in both web and eBook conditions?
- What are the perceptions of ICs of PLWD on the usability, satisfaction and perceived usefulness of the modules in iSupport-Malaysia?
To answer these research questions:
Seventy ICs of PLWD who met the study criteria will be recruited from the geriatric facilities of three hospitals, as well as via social media and referrals from elderly care centres.
Eligible participants will sign an informed consent form, and be randomly assigned to the intervention (iSupport-Malaysia web program) or active comparison group (iSupport-Malaysia eBook) using stratified block randomisation.
In both arms, participants are required to complete at least 10 out of 23 lessons within 3 months.
Outcome measures will be administered online at baseline, 1-month and 3-month follow-up.
Feasibility outcomes will also be measured. Upon completion of the program, ICs in the experimental group will be invited for in-depth interviews via an online teleconferencing platform.
Expected outputs:
A free, adaptive web-based iSupport-Malaysia in the local Malay language. iSupport-Malaysia can facilitate self-directed training in public and private dementia services, integrate into caregiver training programs, and promote self-directed public education on dementia care.
Detailed Description
BACKGROUND
Informal caregivers (ICs) refer to family members who provide unpaid physical and psychological care to their relatives affected by chronic illnesses, including dementia. Caregiving responsibilities often include assisting in activities of daily living (ADLs) of the PLWD, managing medication, as well as providing emotional support to the PLWDs. A recent systematic review revealed that Malaysian ICs of PLWD often experienced moderate to high burden in their caregiving roles due to not knowing how to manage the BPSDs; aside from limited psychosocial support, awareness and education (Mohd Razi et al., 2023).
While face-to-face dementia caregiver training programs have shown benefits, their implementation in low- and middle-income countries (LMICs) faces challenges due to limited awareness, funding, and infrastructure (Pot et al., 2019). Hence, internet-based caregiver interventions may offer a solution to reach more caregivers and increase service coverage. With internet users comprising 96.0% of the total population in Malaysia (98.1% in urban, 89.1% in rural; Department of Statistics, 2022), an online intervention is deemed suitable in the Malaysian context.
To the best of the authors' knowledge, only two interventional studies have been published locally for ICs of PLWD. Hence, the current iSupport study might be one of the first local research studies to evaluate the feasibility, acceptability and preliminary impacts of a digital intervention program on the psychological well-being of ICs of PLWD in Malaysia.
RELATED WORK (PHASE 1 STUDY)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The participants are aware of the intervention they receive (web program or eBook).
Nonetheless, site investigators involved in recruitment are blinded to the randomisation sequence. The data analyst will also be blinded to the intervention assigned to the participants, as all participants' data are labelled using universal subject IDs that do not distinguish between groups of participants. Data collection of baseline and post-intervention assessments will be self-administered online by the participants and remain anonymous. Hence, researchers have no influence over the outcomes of the study.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 years and older, any gender
- •Able to understand written Malay language
- •A self-reported caregiver of person living with any form of dementia (defined by a score of ≥ 2 on the AD8)
- •Provide unpaid care to the PLWD for at least 6 months at the time of recruitment
- •Experience some extent of psychological distress, such that they should experience some levels of subjective burden (defined by a score of ≥ 4 on the 1-item burden scale ranging from 1 to 10), OR some symptoms of depression OR anxiety (defined by a score of ≥ 8 on either the 'depression' or 'anxiety' subscales of HADS)
- •Regular internet user, defined as using the internet at least twice a week.
Exclusion Criteria
- •Already participated in Phase 1 iSupport-Malaysia studies (focus groups, usability testing)
- •Where another family member in the same household has participated/ currently participating in the iSupport study
- •Have limited comprehension of written Malay language
- •Do not have access to a device with an internet connection (e.g. mobile phone, tablet, laptop, desktop) more than twice a week
- •Unable or unwilling to provide written informed consent
Arms & Interventions
iSupport-Malaysia Web-Based Intervention
Access to the online, web-based version of iSupport-Malaysia throughout the 3-month study period. The 23 lessons will be arranged under the 5 modules in the same way as the original iSupport manual. Each lesson will be delivered in bite-sized knowledge, using engaging videos, interactive quizzes with feedback, and reflection exercises. Each lesson will take an average of 10-20 minutes to complete. At the end of each lesson, a completion batch will be given. The lesson plan can be personalised by the caregivers themselves according to individual needs. Caregivers will also have the option to receive a course completion certificate if they successfully completed all 23 lessons in the program.
Additionally, in each lesson, participants are encouraged to post comments in response to the prompt questions, and also reply to others' comments.
Intervention: iSupport-Malaysia Web-Based Intervention (Behavioral)
iSupport-Malaysia eBook
Receive the Malay-translated, culturally adapted version of the 'iSupport for Dementia' manual in PDF format throughout the 3-month study period. This eBook is approximately 275 pages long, containing comprehensive text-based details for the 5 modules and 23 lessons. The modules and lessons are similar to the iSupport-Malaysia web-based program. Each lesson includes at least one case 1 scenario(s) presented in a quiz format. Some lessons offer additional worksheets for caregivers to reflect on their own caregiving experiences and apply the strategies learned to their caregiving journey. A completion batch is given at the end of each lesson. The lesson plan can be personalised by the caregivers themselves according to individual needs.
Intervention: iSupport-Malaysia eBook (Behavioral)
Outcomes
Primary Outcomes
Recruitment Feasibility
Time Frame: Screening
Percentage of ICs who meet the eligibility criteria among all the screened ICs of PLWD.
Randomisation Feasibility
Time Frame: Baseline
Percentage of ICs who agree to randomisation among all eligible ICs.
Retention Rates
Time Frame: 3 months
Percentage of participants retained until the end of the study in both arms.
Program Engagement Rate
Time Frame: 3 months
Percentage of ICs who comply to the treatment protocol in both arms.
Secondary Outcomes
- Hospital Anxiety & Depression Scale (HADS), Malay version(Baseline, 1 month, 3 months)
- Perceived Stress Scale (PSS-10), Malay version(Baseline, 1 month, 3 months)
- Zarit Burden Interview (ZBI), Malay version(Baseline, 1 month, 3 months)
- WHO Quality of Life, Brief Version (WHOQOL-BREF), Malay version(Baseline, 1 month, 3 months)
Investigators
Ken Joey Loh
Clinical Psychologist & PhD Candidate
Sunway University