Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Experimental Study
- Conditions
- StrokePsychological Well-BeingPsychosocial Functioning
- Interventions
- Behavioral: Pre-Post ARCH Intervention
- Registration Number
- NCT06596551
- Lead Sponsor
- Nanyang Technological University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pre-Post ARCH Intervention Pre-Post ARCH Intervention Participants will receive the ARCH intervention, a 4-weekly, 6-hour, strength-based dyadic programme that integrates psychoeducation, psychosocial support, and self-compassion practices to encourage and inspire families recovering from a first-time stroke. Specific intervention components include family education, facilitated dyadic communication and mindful self-compassion practices. Weekly therapeutic objectives build upon each other to provide affected families with the necessary means to process the trauma of experiencing a stroke and learning to live amidst multiple post-stroke losses.
- Primary Outcome Measures
Name Time Method Change in well-being from baseline (patient) 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) 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) 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) 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) 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.
- Secondary Outcome Measures
Name Time Method 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 The Dyadic Relationship Scale (DRS) utilizes a 4-point scale to measure both the patient and the family caregiver's perspectives on the positive and negative aspects of their dyadic interactions.
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 The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) is a 12-item questionnaire that utilizes a 4-point scale to measure overall spiritual well-being and it's components on three sub-scales (faith, meaning and peace).
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 The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that utilizes a 4-point scale to measure symptoms of psychological distress in non-psychiatric clinical settings.
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 The Lubben Social Network Scale 6 (LSNS-6) is a 6-item questionnaire that utilizes a 6-point scale to assess social networks, available social support and screen for social isolation
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 The Brief Resilience Scale (BRS) is a 6-item questionnaire that utilizes a 5-point scale to assess an individual's perceived ability to bounce back or recover from stress.
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 The Herth Hope Index (HHI) is a 12-item questionnaire that utilizes a 4-point scale to measure hope in clinical settings with terminally ill adults.
Trial Locations
- Locations (1)
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore