Resilience-Building Intervention for Older Informal Caregivers
2026年7月14日 更新者：Vivien Xi WU, PhD、National University of Singapore
Community-Based Resilience-Building Intervention for Older Informal Caregivers: Protocol for a Cluster Randomized Feasibility Trial
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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ruochen Feng
- 电话号码：+6566012756
- 邮箱：rfeng@nus.edu.sg
研究联系人备份
- 姓名：Vivien Xi Wu
- 邮箱：vivien.wu@nus.edu.sg
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Multicomponent Resilience-building Program
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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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.
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有源比较器：AI Chatbot and Telephone Follow-up Group
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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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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无干预：Usual Practice
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment Rate
大体时间：From date of randomization until the date of first session of the intervention, assessed up to 2 months.
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Proportion of eligible participants who provide informed consent and complete baseline assessment.
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From date of randomization until the date of first session of the intervention, assessed up to 2 months.
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Participant Retention Rate
大体时间：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.
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Proportion of enrolled participants who complete the post-intervention (T1) and 3-month follow-up (T2) assessments.
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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.
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Intervention Adherence
大体时间：Throughout the 8-week intervention period.
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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.
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Throughout the 8-week intervention period.
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Intervention Acceptability
大体时间：Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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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
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Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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AI Chatbot Usability
大体时间：Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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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.
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Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Psychological Resilience
大体时间：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.
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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.
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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.
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Intrinsic Capacity
大体时间：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.
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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.
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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.
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Health Self-Efficacy
大体时间：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.
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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.
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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.
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Social Isolation
大体时间：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.
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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.
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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.
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Caregiver burden
大体时间：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.
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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.
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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.
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Resource Awareness and Navigation
大体时间：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.
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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.
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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.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Exploratory digital engagement outcomes
大体时间：Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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Assessed using AI chatbot usage analytics, including interaction time, frequency, query categories and click-through rates for recommended resources.
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Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
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Intracluster Correlation Coefficient for Future Trial Planning
大体时间：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.
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Estimated for key feasibility and exploratory outcome measures to inform sample size calculation and design considerations for a future definitive cluster randomized controlled trial.
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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.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年3月31日
研究完成 (估计的)
2027年3月31日
研究注册日期
首次提交
2026年6月30日
首先提交符合 QC 标准的
2026年7月14日
首次发布 (实际的)
2026年7月17日
研究记录更新
最后更新发布 (实际的)
2026年7月17日
上次提交的符合 QC 标准的更新
2026年7月14日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- NUS-IRB-2023-889
- A-8001599-00-00 (其他赠款/资助编号：National University Health System Seed Grant)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.