Clinical trial NCT06596551: Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Experimental Study
Official title: Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Evaluation of Psychosocial Recovery in First-Time Stroke Survivors and Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Psychological Well-Being
Psychosocial Functioning
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: Tan Tock Seng Hospital
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post single arm study design will measure psychosocial health outcomes before and again after the intervention is implemented. This study design is adopted for the purposes of a pilot investigation to observe if the ARCH intervention can have temporary effects or no effects on psychosocial health outcomes.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in well-being from baseline (patient)
timeFrame: 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
measure: Change in well-being from baseline (caregiver only)
timeFrame: 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
measure: Change in post-stroke reintegration from baseline (patient only)
timeFrame: 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
measure: Change in caregiver burden from baseline (caregiver only)
timeFrame: 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
measure: Change in self-efficacy from baseline (patient only)
timeFrame: 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
Secondary outcomes:
measure: Changes in dyadic relationship interactions from baseline
timeFrame: 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
measure: Change in spiritual well-being from baseline
timeFrame: 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
measure: Change in anxiety and depression symptoms from baseline
timeFrame: 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
measure: Changes in perception of social support from baseline
timeFrame: 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
measure: Change in resilience from baseline
timeFrame: 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
measure: Change in hope from baseline
timeFrame: 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
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
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