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| ID | Type | Description | Link |
|---|---|---|---|
| A-8001599-00-00 | Other Grant/Funding Number | National University Health System Seed Grant |
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| Name | Class |
|---|---|
| Lions Befrienders Service Association (Singapore) | UNKNOWN |
| FlocCare Pte. Ltd | UNKNOWN |
| National University Health System, Singapore | OTHER |
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The goal of this pilot study is to test whether a newly developed resilience-building program is feasible and acceptable for older adults who provide unpaid care to people with functional impairment in the community. The program was developed based on earlier research with older caregivers, existing scientific evidence, and feedback from key stakeholders.
The main questions this study aims to answer are:
Researchers will compare:
Participants will:
Findings from this pilot study will help refine the intervention and study procedures of a larger future trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent Resilience-building Program | Experimental | 8-week multicomponent resilience-building intervention comprising alternating weekly in-person and online sessions. Key components include: 1) psychoeducation; 2) peer support group sharing; and 3) access to an AI chatbot for caregiving support. |
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| AI Chatbot and Telephone Follow-up Group | Active Comparator | Access to the AI chatbot trained using local official health education and caregiving support resources, with weekly telephone follow-up calls to guide chatbot use and address technical difficulties. |
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| Usual Practice | No Intervention | Participants in the control arm will not receive the intervention or access to the AI chatbot during the study period until the last follow-up assessment. They will continue their usual caregiving routine and existing care practices as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent Resilience-building Program | Behavioral | Participants in the intervention group will receive the THRIVE program, an 8-week multicomponent resilience-building intervention developed based on prior participant need assessment, empirical evidence on resilience theory and caregiver resilience interventions, and stakeholder input. The intervention aims to strengthen psychological resilience among older informal caregivers. The format will be alternating in-person and online sessions conducted weekly over 8 weeks. In-person sessions will be held at participating Active Ageing Centres, while online sessions will be conducted through Telegram group video calls. Each 1.5-hour session will include: 1) psychoeducation; 2) peer support group sharing; and 3) an AI chatbot trained using local official resources. Sessions will be delivered by the same trained facilitator using a standardized intervention protocol. An independent observer will complete a fidelity checklist during each session to assess adherence to the protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Proportion of eligible participants who provide informed consent and complete baseline assessment. | From date of randomization until the date of first session of the intervention, assessed up to 2 months. |
| Participant Retention Rate | Proportion of enrolled participants who complete the post-intervention (T1) and 3-month follow-up (T2) assessments. | Assessed from the first session of the intervention to Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point. |
| Intervention Adherence | Participant adherence to intervention activities, including attendance at in-person and online sessions, completion of telephone follow-up calls, and engagement metrics with the AI chatbot. | Throughout the 8-week intervention period. |
| Intervention Acceptability | Participant acceptability of the intervention will be assessed using a post-intervention satisfaction survey and qualitative feedback collected through focus group discussions to explore participants' experiences, perceived usefulness of the intervention, barriers and facilitators to participation, and recommendations | Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. |
| AI Chatbot Usability | Usability of the AI chatbot will be assessed using the Simplified System Usability Scale (SUS). The SUS consists of 10 items rated on a 5-point Likert scale. Responses are converted to produce a total score ranging from 0 to 100, with higher scores indicating better perceived usability. | Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Resilience | Assessed using the Connor-Davidson Resilience Scale (CD-RISC-25) to explore preliminary trends in intervention effects on resilience. The CD-RISC-25 consists of 25 items, with total scores ranging from 0 to 100. Higher scores indicate greater psychological resilience. | Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory digital engagement outcomes | Assessed using AI chatbot usage analytics, including interaction time, frequency, query categories and click-through rates for recommended resources. | Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. |
| Intracluster Correlation Coefficient for Future Trial Planning |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruochen Feng | Contact | +6566012756 | rfeng@nus.edu.sg | |
| Vivien Xi Wu | Contact | vivien.wu@nus.edu.sg |
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The decision regarding sharing of de-identified individual participant data has not yet been finalized. Data sharing will be considered following study completion, taking into account participant consent, ethical and regulatory requirements, institutional policies, and the potential risk of participant re-identification due to the relatively small sample size and specific study population.
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This study uses a 3-arm parallel cluster randomized design. Participating Active Ageing Centres will be randomly assigned to one of three groups: the THRIVE intervention group, the active control group, or the usual care control group.
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Group allocation will be coded using neutral labels (e.g., Group A, Group B, and Group C) throughout data management and analysis. Due to the nature of the intervention, participants and intervention facilitators cannot be masked to group allocation. As all outcomes are assessed using self-reported questionnaires, outcome assessor masking is not applicable. Data analysts will remain masked to group allocation until the primary feasibility and outcome analyses have been completed and documented. Unmasking will occur only after the analysis plan has been finalized and all primary analyses have been conducted.
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| AI Chatbot and Telephone Follow-up Group | Behavioral | Participants will receive access to the same AI chatbot trained using information from local official health education and caregiving support resources. Participants will also receive weekly telephone follow-up calls from the research team over the 8-week study period. The telephone follow-ups aim to: 1) encourage use of the AI chatbot; 2) address any technical difficulties encountered during chatbot use; and 3) gather participants' feedback and experiences using a standardized telephone follow-up guide. All telephone calls will be audio-recorded and reviewed by the research team for fidelity monitoring to ensure consistency of delivery across participants. |
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| Intrinsic Capacity | Intrinsic capacity will be assessed using the World Health Organization (WHO) Integrated Care for Older People (ICOPE) screening tool to explore preliminary trends in intervention effects on intrinsic capacity. The tool assesses six domains of intrinsic capacity. Each domain is scored as 1 if no impairment is identified and 0 if impairment is present, yielding a total score ranging from 0 to 6, with higher scores indicating better intrinsic capacity. | Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point. |
| Health Self-Efficacy | Health self-efficacy will be assessed using the Self-Rated Abilities for Health Practices Scale (SRAHP). The SRAHP consists of 28 items assessing self-perceived ability to perform health-promoting behaviours across four domains: exercise, nutrition, responsible health practices, and psychological well-being. Total scores range from 0 to 112, with higher scores indicating greater health self-efficacy for health-promoting practices. | Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point. |
| Social Isolation | Social isolation will be assessed using the Social Isolation Scale (SIS). The SIS consists of 6 items assessing the size and quality of participants' social relationships and social connectedness. Total scores range from 6 to 30, with higher scores indicating lower levels of social isolation (greater social connectedness) and lower scores indicating greater social isolation. | Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point. |
| Caregiver burden | Caregiver burden will be assessed using the 4-item Zarit Burden Interview (ZBI-4). The ZBI-4 consists of 4 items assessing the perceived impact of caregiving on the caregiver's time, stress, strain, and uncertainty. Total scores range from 0 to 16, with higher scores indicating greater caregiver burden. | Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point. |
| Resource Awareness and Navigation | This outcome will be assessed using a study-specific 2-item questionnaire developed for this pilot study. The questionnaire evaluates participants' awareness of caregiving support services and confidence in accessing caregiving support when needed. Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Total scores range from 2 to 10, with higher scores indicating greater awareness and confidence in accessing caregiving support resources. | Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point. |
Estimated for key feasibility and exploratory outcome measures to inform sample size calculation and design considerations for a future definitive cluster randomized controlled trial. |
| Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point. |