Clinical trial NCT06883708: Feasibility & Preliminary Impacts of an Online Psychoeducational Program (iSupport-Malaysia) for Informal Dementia Caregivers
Official title: iSupport-Malaysia: An Online Psychoeducational Intervention Program for Informal Dementia Caregivers in Malaysia - A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Subjective Burden
Caregiver Wellbeing
Feasibility Pilot Study
Keywords: informal caregivers
dementia
caregiver support
internet-based intervention
psychoeducation
Lead sponsor: Sunway University
Sponsor class: OTHER
Collaborators: name: Sarawak General Hospital
name: Sarawak Heart Centre
name: University of Malaya
name: University Malaya Medical Center, Selangor
First posted: 2025-03-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental parallel between-group design with two arms
Primary purpose: SUPPORTIVE_CARE

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:

1. How feasible is it to implement iSupport-Malaysia as an accessible resource for ICs of PLWD in Malaysia?
2. Does the use of iSupport-Malaysia lead to a reduction in caregiver burden among the ICs of PLWD in both web and eBook conditions?
3. 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?
4. 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)

The investigators have obtained permission from the WHO to culturally adapt "iSupport for Dementia"© into the local Malaysian context. Upon professional translation of all texts in the generic iSupport into the local Malay language, all content in the eBook has been adapted into short educational videos. These videos, interactive quizzes, and reflection exercises were then hosted on a Learning Management System (LMS) platform, creating the iSupport-Malaysia web-based intervention program.

The first two web prototypes were evaluated critically by conducting focus groups and usability testing sessions with stakeholders (healthcare professionals, formal and informal caregivers of PLWD). Feedback obtained from these sessions was used to improve the content and user interface of the web prototype. Content validation was also performed via quantitative and qualitative appraisals, as well as fidelity checks by the program authors from the WHO.

At the time of writing, the Phase 1 study data collection has been completed. The current study protocol focuses on the Phase 2 Pilot Feasibility Study.

METHODOLOGY

STUDY DESIGN:

This is an experimental pilot feasibility study adopting mixed-methods, two-arm parallel randomised controlled design.

Eligible ICs of PLWD will be randomised (1:1 ratio) into either: (1) iSupport-Malaysia web-based intervention; or (2) iSupport-Malaysia eBook.

Web intervention group will be given access to the iSupport-Malaysia website throughout the study period. The eBook comparison group will be provided with iSupport-Malaysia eBook throughout the study period. After the intervention ends, both groups will receive access to both the website and eBook.

Study duration per participant is 3 months. Assessments on psychological wellbeing are administered pre-measurement (t0), first follow-up (t1, 1 month after t0), and second follow-up (t2, 3 months after t0). Data will be collected online via secured REDCap platform.

RANDOMISATION:

Stratified block randomisation will be used to randomly assign eligible, consented participants to either the web intervention or eBook condition.

First, participants will be stratified by gender (male or female); and relationship of the IC to the PLWD (child or non-child).

Then, participants will be randomised with 1:1 allocation using a block size of 2.

To prevent researcher bias, the randomisation tables for each striatum will be prepared by an independent researcher not involved in participant recruitment. The same independent researcher will provide the group allocation of the participants upon obtaining the enrolment list.

SAMPLE:

Study population:

All informal caregivers (ICs) who are currently taking care of a person living with dementia (PLWD). The ICs of PLWD included in this study are all self-reported adult family caregivers for dementia persons from Universiti Malaya Medical Centre (UMMC), Sarawak General Hospital (SGH), Sarawak Heart Centre (SHC), caregivers' support groups (online/ offline), and elderly care centres around the nation.

Sampling method:

Convenient sampling will be used for in-person recruitment at geriatric facilities at hospital sites (UMMC, SGH and SHC).

Volunteer sampling will be used for online recruitment from caregivers' support groups (online social media/ offline), and elderly care centres around the nation.

Sample size:

For a two-armed pilot trial, several rules of thumb have provided an estimation of the total sample size to range between 20 and 70.

Whitehead et al. (2016) recommended a sample size of 25 per treatment arm to achieve a power of 90%, two-sided significance of 0.05, and a small standardised effect size (0.1 \< σ \< 0.3).

Conservatively considering a dropout rate of 40% in this pilot study, a total of 70 ICs of PLWD will be recruited (35 per treatment arm).

DATA COLLECTION:

1. Screening Procedure:

   Hospital Sites: Site investigators at respective hospital sites will approach ICs of PLWD at the clinic waiting area or geriatric wards to explain the iSupport study. Interested ICs will fill up the pen-and-paper screening questionnaires on the spot.

   Other Sites: Investigators will post and circulate the study advertisement in English and Bahasa Malaysia on social media (caregivers' support groups on Facebook and WhatsApp), and elderly care centres contacts. Interested ICs will scan the QR code on the study poster to register their interest. Then, the investigator will contact the ICs and send a secured REDCap link to the online screening questionnaire.

   The screening questionnaires include: i) Brief demographic questionnaire assessing the inclusion \& exclusion criteria; ii) Ascertain Dementia 8-item (AD8), Malay version; iii) 1-item burden scale; iv) Hospital Anxiety \& Depression Scale (HADS), Malay version.
2. Informed Consent Procedure:

   Hospital Sites: Eligible ICs will be given the physical information sheet to read and ask questions about the study. If they agree to participate, they will sign the hardcopy informed consent form.

   Other Sites: Eligible ICs will be sent (via email or WhatsApp) the PDF version of the information sheet to read and ask questions about the study. If they agree to participate, they will insert their digital signature and return the signed consent form to the investigator. Once the signed consent form is downloaded to the investigator's password-protected personal computer, the investigator will delete the consent form copy from the email and WhatsApp chat (to protect participants' privacy in the event of data breach).

   Consented participants will be told that they will receive their group allocation, secured questionnaire links and further instructions via email.

   Ineligible participants will not be invited to join the study. Nonetheless, the investigator will offer them the generic English version of the "iSupport for Dementia" eBook, and also an option of whether they would like to receive the culturally adapted version of iSupport eBook in Bahasa Malaysia after study closure. They will also be encouraged to speak to their healthcare providers and seek support from local dementia associations.
3. Baseline Measurement and Group Allocation:

   The enrolment list will be given to the independent researcher doing the randomisation, who shall then revert back to the P.I. about the group allocation of each consented participant.

   P.I. will email consented participants to inform them about their group allocation, and attach the secured link to complete the baseline questionnaires via REDCap.

   Participants can reach out to the investigator via phone, WhatsApp or email if they have any questions.
4. Procedure of Intervention:

   According to their group allocation, participants will receive access to either the iSupport-Malaysia website or the iSupport-Malaysia eBook throughout the study period.

   At 1 month and 3 months after randomisation, participants will be emailed secured links to complete the 1-month and 3-month follow-up assessments on REDCap.

   Finally, at the end of the 3-month intervention, selected participants from the web group will be invited to a virtual semi-structured interview (via Zoom) to gather their user experience and insights until data saturation is reached.
5. Treatment Compliance Protocol:

To ensure consistent 'dosage' and treatment effect, participants in both groups are encouraged to: i) use the iSupport at least once a week; ii) complete a minimum of 10 lessons at the end of the 3-month intervention program.

Email or WhatsApp reminders will be sent once per fortnight to encourage continuous usage.

Intervention adherence will be monitored during the 1-month and 3-month follow-up, where participants will be asked to self-report: i) whether they have used the iSupport every week for the past 1 month/ 3 months; ii) the average duration spent on iSupport every week; and iii) the total number of lessons completed in 1 month / 3 months respectively.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: Screening
measure: Randomisation Feasibility
timeFrame: Baseline
measure: Retention Rates
timeFrame: 3 months
measure: Program Engagement Rate
timeFrame: 3 months
Secondary outcomes:
measure: Zarit Burden Interview (ZBI), Malay version
timeFrame: Baseline, 1 month, 3 months
measure: Hospital Anxiety & Depression Scale (HADS), Malay version
timeFrame: Baseline, 1 month, 3 months
measure: Perceived Stress Scale (PSS-10), Malay version
timeFrame: Baseline, 1 month, 3 months
measure: WHO Quality of Life, Brief Version (WHOQOL-BREF), Malay version
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
measure: System Usability Scale (SUS), Malay version
timeFrame: 3 months
measure: Ascertain Dementia 8-item (AD8), Malay version
timeFrame: Screening
measure: Sociodemographic Data
timeFrame: Screening, baseline
measure: Program Acceptability
timeFrame: 3 months
Locations:
city: Kota Samarahan
country: Malaysia
facility: Sarawak Heart Centre
state: Sarawak
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Subang Jaya
country: Malaysia
facility: Sunway University
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: University Malaya Medical Centre, Selangor
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Sunway University
name: Ken Joey Loh, MPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunway University
name: Alvin Lai Oon Ng, DPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loh KJ, Ng ALO, Chia YC, Lee WL, Mohan D, Renganathan E. Caring for people living with dementia and their informal caregivers: Current perspectives in Malaysia. Malays Fam Physician. 2024 Dec 27;19:69. doi: 10.51866/cm.674. eCollection 2024.