Community-Based Resilience-Building Intervention for Older Informal Caregivers: Protocol for a Cluster Randomized Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Recruitment Rate
研究概览
简要总结
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:
- Can older caregivers be successfully recruited and retained in the study?
- Is the program feasible and acceptable to deliver in community settings?
- Does the program show potential to improve resilience among older caregivers?
Researchers will compare:
- an intervention group receiving an 8-week multicomponent resilience-building intervention delivered through alternating in-person and online sessions at participating Active Ageing Centres and through Telegram group video calls. The program includes psychoeducation, peer support group, and access to an artificial intelligence (AI) chatbot developed to support caregivers.
- an active control group receiving access to the AI chatbot and weekly telephone follow-up only.
- a control group continuing their usual caregiving routine.
Participants will:
- Be assigned to 1 of the 3 study groups based on the Active Ageing Centre they attend.
- Complete self-reported questionnaires before the intervention (T0, baseline), immediately after the intervention (T1, post-intervention), and 3 months later (T2, follow-up).
- Some participants may also be invited to participate in focus group discussions after the 8-week intervention period as part of a process evaluation to explore their experiences, perceived usefulness of the intervention components, barriers and facilitators to participation, and recommendations for refinement.
Findings from this pilot study will help refine the intervention and study procedures of a larger future trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be aged 60 to 85 years;
- •Reside in the community;
- •Be attending a participating Lions Befrienders Active Ageing Centre;
- •Be able to communicate in English or Mandarin;
- •Have an Abbreviated Mental Test (AMT) score of 8 or above;
- •Self-identify as an informal caregiver providing unpaid care to a family member, friend, or other individual;
- •Provide care to a care recipient with impairment in at least one activity of daily living, as assessed using the Older Americans Resources and Services Activities of Daily Living (OARS-ADL) scale;
- •Have at least weekly contact with the care recipient.
排除标准
- •Have severe visual or hearing impairment that would prevent participation in study activities;
- •Have a known diagnosis of dementia or other severe cognitive impairment;
- •Have a known diagnosis of a severe psychiatric disorder that may impair study participation (e.g., psychotic disorders);
- •Have an AMT score below 8;
- •Provide care primarily to grandchildren or children under 18 years of age, rather than to an adult with functional impairment.
结局指标
主要结局
Recruitment Rate
时间窗: From date of randomization until the date of first session of the intervention, assessed up to 2 months.
Proportion of eligible participants who provide informed consent and complete baseline assessment.
Participant Retention Rate
时间窗: 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.
Proportion of enrolled participants who complete the post-intervention (T1) and 3-month follow-up (T2) assessments.
Intervention Adherence
时间窗: Throughout the 8-week intervention period.
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.
Intervention Acceptability
时间窗: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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
AI Chatbot Usability
时间窗: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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.
次要结局
- 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.)
- 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(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(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(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(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.)
研究者
Vivien Xi WU, PhD
Assistant Professor
National University of Singapore