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.
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
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
Parallel
iSupport-Malaysia Web-Based Intervention
BehavioraliSupport-Malaysia web-based intervention is a website version of the culturally adapted "iSupport for Dementia" into the Malaysia context (in local Malay language). The 23 lessons is arranged under the 5 modules in the same way as the original iSupport manual. Each lesson is delivered in bite-sized knowledge, using engaging videos, interactive quizzes with feedback, and reflection exercises. Each lesson takes an average of 10-20 minutes to complete. At the end of each lesson, a completion batch is 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 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.
iSupport-Malaysia eBook
BehavioraliSupport-Malaysia eBook is the Malay-translated, culturally adapted version of the "iSupport for Dementia" manual in PDF format. 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. The main lesson content is delivered in text-based format. 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.
Recruitment Feasibility
Percentage of ICs who meet the eligibility criteria among all the screened ICs of PLWD.
Randomisation Feasibility
Percentage of ICs who agree to randomisation among all eligible ICs.
Retention Rates
Percentage of participants retained until the end of the study in both arms.
Program Engagement Rate
Percentage of ICs who comply to the treatment protocol in both arms.
Zarit Burden Interview (ZBI), Malay version
Caregiver subjective burden will be measured using Zarit Burden Interview (ZBI), Malaysia validated version (in Malay language). The ZBI is a 22-item self-report questionnaire that measures subjective burden in caregivers. Items are rated on a 5-point scale from 0 (never) to 4 (almost always). Total scores range from 0 to 88, with higher scores indicating greater subjective burden. The total scores are categorised into: 0-20 (little or no burden), 21-40 (mild to moderate burden), 41-60 (moderate to severe burden), and 61-88 (severe burden). Nonetheless, the validation study in Malaysia suggested a score of 22 as the suitable cut-off score for M-ZBI scale in the local population. At this cut-off, the M-ZBI demonstrated 70.8% sensitivity and 69.2% specificity for detecting burden among Malaysian caregivers (Shim et al., 2018). Changes in subjective burden will be assessed by M-ZBI total scores from baseline to 1-month and 3-month follow-ups.
Hospital Anxiety & Depression Scale (HADS), Malay version
The HADS measures symptoms of anxiety and depression through total scores obtained on its respective 7-item subscales, using a 4-point scale each (Snaith \& Zigmond, 1986). Subscale scores range from 0-21, with higher scores indicating more severe anxiety or depression. The Malaysia-validated version in Malay language will be administered. Changes in symptoms of depression and anxiety will be assessed by the HADS-D and HADS-A subscale scores from baseline to 1-month and 3-month follow-ups.
Perceived Stress Scale (PSS-10), Malay version
The 10-item PSS aims at assessing the extent to which an individual appraises life events as stressful (Cohen et al., 1983). This questionnaire requires the participants to rate the degree to which their lives had been unpredictable, uncontrollable and overloading for the past month. The items were designed on a five-point Likert scale, from 0 (never) to 4 (very often). Item responses will be summed after reverse-scoring four items, yielding a total score for perceived stress. The Malaysia-validated version in Malay language will be administered. Changes in perceived stress will be assessed by PSS-10 total scores from baseline to 1-month and 3-month follow-ups.
WHO Quality of Life, Brief Version (WHOQOL-BREF), Malay version
The WHOQOL-BREF assesses quality of life (QoL) through scores on four domains: physical health, psychological, social relationships and environment (The WHOQOL Group, 1998). Participants will be required to answer two general questions on overall QoL and health satisfaction; as well as 24 specific questions assessing physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Their experiences over the past two weeks will be rated on 5-point scale. This 26-item instrument will produce transformed scores from 0-100, with higher scores representing better QoL. The Malaysia-validated version in Malay language will be administered. Changes in quality-of-life scores will be assessed by WHOQoL-BREF total scores from baseline to 1-month and 3-month follow-ups.
System Usability Scale (SUS), Malay version
The System Usability Scale (SUS) (Brooke, 1996) will be used to evaluate the usability of iSupport-Malaysia web-based program. Each statement in the questionnaire will be rated on a 5-point Likert scale of 0 (strongly agree) to 4 (strongly disagree). Total scores range from 0 to 40, and will be multiplied by 2.5 to convert the scores to 0-100. Higher scores indicate better usability of a website. The Malaysia-validated version in Malay language will be administered. Here, the SUS will be administered to the web-based intervention group upon study completion. A total score of 68 and above would indicate above average usability score of our iSupport-Malaysia web version of the intervention.
Ascertain Dementia 8-item (AD8), Malay version
Ascertain Dementia 8-item (AD8) (Galvin et al., 2005) is a brief informant-based questionnaire used to screen for cognitive impairment and dementia. It consists of 8 questions that are answered by a reliable informant, such as a family member or close friend of the patient being evaluated. The informant will rate changes in the patient's memory, problem-solving abilities, orientation, daily activities, and adaptive functioning compared to a few years ago. Each item is answered by selecting one of the three options: "Yes, A Change", "No, No Change", or "N/A, Don't Know". The final score is the sum of the number of items answering "Yes, A Change". Total score ranges from 0 to 8, with higher scores indicating greater cognitive impairment. The Malaysia-validated version in Malay language will be administered. At screening, the cut-off score of 2 and above indicates that the care recipient has cognitive difficulties.
Sociodemographic Data
General information about the ICs will be obtained: age, gender, ethnicity, religion, occupation, job status, educational level, marital status, relationship to the PLWD, average hours of care per week, and living arrangements (whether they are staying with the PLWD under the same roof). Specific information about the care-recipients' characteristics and illness-related information of the PLWD will also be obtained: age, gender, existence of official diagnosis, type of dementia, and time since diagnosis.
Program Acceptability
A series of semi-structured interviews will be conducted with participants from the iSupport web-based intervention group, evaluating aspects such as: 1) motivation to participate; 2) user experience and barriers; 3) satisfaction with content, interface design and features; 4) program endorsement; and 5) any inconvenience / harm related to the study procedure (e.g. too many questionnaires, reasons for dropping out). Thematic analysis will be used to code the transcripts and derive themes.
Click on the lead sponsor to view all of their trials.
Sunway University
Lead sponsor
Sarawak General Hospital
Collaborator
Sarawak Heart Centre
Collaborator
University of Malaya
Collaborator
