Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Evaluation of Psychosocial Recovery in First-Time Stroke Survivors and Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in well-being from baseline (patient)
研究概览
简要总结
The ARCH programme is a novel, strength-based, dyadic, multicomponent psychosocial intervention that blends together psychoeducation, psychosocial support and self-compassion practices to aid first-time stroke survivors and their family caregivers with their psycho-socio-emotional and spiritual challenges following discharge from in-patient care. A pre-post experimental design with a feasibility and acceptability assessment is adopted to evaluate and refine the ARCH intervention in promoting wellbeing, self-compassion, independence, quality of life, hope, resilience, self-efficacy and dyadic mutuality.
详细描述
Objective
The current study utilizes the empirical foundations of psychosocial recovery in first-time stroke dyads to pilot test the Aspirational Rehabilitation Coaching for holistic Health (ARCH) programme. The core objectives of this study is to 1) critically assess the pre-post effects in participants' psycho-socio-emotional and spiritual wellbeing and 2) qualitatively evaluate the feasibility and acceptability of the intervention in addressing post-stroke psychosocial challenges.
Methods: For this pilot study a total of 30 survivor-caregiver dyads (N=60; 30 survivors, 30 caregivers) will be recruited directly through referrals from the collaborating hospital. The proposed sample size reflects the approximate or working number of qualitative interviews at which one could expect to be reach theoretical saturation (Morse, 2000). Participants above the ages of 21 years, recovering from their first stroke at mild to moderate degree of severity, discharged from inpatient care at no later than 3 months, clinically assessed to have cognitive capacities to engage in and complete the research study, with language capabilities in English or Mandarin and one identified primary family caregiver over the age of 21 will be recruited for this study. Consenting family dyads will undergo a 4-week dyadic intervention that integrates psychoeducation, psychosocial support, and self-compassion practices. The rationale for the intervention components was based on an in-depth analysis of the psychosocial needs and challenges of stroke survivors and family caregivers reported in the international literature, and the lived experiences of post-stroke loss, coping strategies and recovery needs of Singaporean first-time stroke survivors and family caregivers. Quantitative measurements will be taken at baseline [time point 1 (T1)], immediately after the intervention [T2], 3 months [T3] and 6 months [T4] post-intervention. The qualitative assessment of feasibility and acceptability will be conducted at post intervention [T2].
Significance: The absence of tailored, family-centered support in current stroke rehabilitation practices suggest that more and more individuals are left to their own devices in navigating this psychologically, socially, and emotionally devastating health event. Dyads participating in this study will experience, for the first time ever, a rehabilitative programme that is solely focused in providing them the comfort and support in managing their unique psycho-socio-emotional and spiritual challenges post-stroke. Results from this study hope to inform the large stroke community and eventually find advocate for the ARCH intervention to become a part of standard clinical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21 years and above
- •Recovering from their first stroke at mild to moderate degree of severity
- •Discharged from inpatient care at no later than 3 months,
- •Clinically assessed to have cognitive capacities to engage in and complete the research study,
- •Language capabilities in English or Mandarin, and
- •One identified primary family caregiver aged 21 years and above with similar language capabilities.
排除标准
- •Families with survivors suffering from aphasia,
- •Being too ill to participate,
- •Experiencing moderate to severe cognitive impairment, and
- •With family caregivers who are not interested to participate.
结局指标
主要结局
Change in well-being from baseline (patient)
时间窗: Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention
The 7-item short version of the Warwick Edinburgh Mental Well-being Scale (SWEMWBS) is a measure of mental well-being. Participants will be assessed on a 5-point scale.
Change in well-being from baseline (caregiver only)
时间窗: Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention
The 8-item short version of the WHOQOL-100 and the WHOQOL-BREF, that assesses four domains of quality of life (psychological, physical, social, and environmental). Participants will be assessed on a 5-point scale.
Change in post-stroke reintegration from baseline (patient only)
时间窗: Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention
The Modified Reintegration to Normal Living Index (mRNLI) is a 11-item questionnaire that evaluates reintegration to normal living after incapacitating illness or trauma on a 4-point scale.
Change in caregiver burden from baseline (caregiver only)
时间窗: Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention
The Zarit Burden Interview Short (ZBI-Short) is a 12-item questionnaire that assesses caregiver burden on a 4-point scale.
Change in self-efficacy from baseline (patient only)
时间窗: Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention
The General Self-Efficacy Scale (GSES) is a 10-item questionnaire that utilizes a 4-point scale to measure perceived self-efficacy is areas of goal setting, effort investment, persistence in face of barriers and recovery from setbacks.
次要结局
- Changes in dyadic relationship interactions from baseline(Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention)
- Change in spiritual well-being from baseline(Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention)
- Change in anxiety and depression symptoms from baseline(Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention)
- Changes in perception of social support from baseline(Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention)
- Change in resilience from baseline(Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention)
- Change in hope from baseline(Participants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-intervention)
研究者
Andy Hau Yan Ho, PhD, EdD
Professor
Nanyang Technological University