Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Experimental Study

Nanyang Technological University

Status: Enrolling

Conditions: Psychological Well-Being; Stroke; Psychosocial Functioning

Treatments: Behavioral: Pre-Post ARCH Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06596551

IRB-2023-00-355

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Pre-Post ARCH Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Pre-Post ARCH Intervention