Resilience-Building Intervention for Older Informal Caregivers

Официальное название

Community-Based Resilience-Building Intervention for Older Informal Caregivers: Protocol for a Cluster Randomized Feasibility Trial

Обзор

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.

Вмешательства

• Поведенческое Multicomponent Resilience-building Program
  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
• Поведенческое AI Chatbot and Telephone Follow-up Group
  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-

Первичные конечные точки

• Recruitment Rate [Срок оценки: From date of randomization until the date of first session of the intervention, assessed up to 2 months.]
• Participant Retention Rate [Срок оценки: 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 [Срок оценки: Throughout the 8-week intervention period.]
• Intervention Acceptability [Срок оценки: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.]
• AI Chatbot Usability [Срок оценки: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.]

Вторичные конечные точки (6)

• Psychological Resilience [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07712744 · NUS-IRB-2023-889 · A-8001599-00-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗