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NCT Number: NCT06596551

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

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Personal Satisfaction Psychological Well-Being Psychosocial Functioning Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore

Location status: Recruiting

Location contact

Gwen Chan, MBBS

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-Post ARCH Intervention

Behavioral

Stroke dyads, consisting of a survivor and primary family caregiver, will engage in a 4 weekly, 1.5 hour experiential dyadic sessions, totalling 6 hours of participation. In Week 1, dyads acknowledge the losses occurring after the stroke to normalize feelings of grief and sadness and find comfort within the familial space. In Week 2, dyads interpret their post-stroke losses within the framework of their existing knowledge for managing adversities (strengths, resources, and values) and identify changes that are most meaningful to them. In Week 3, dyads set specific, measurable, and achievable goals to actualize the meaningful changes identified in Week 2. Finally in Week 4, dyads bring together their individually derived strengths from the previous sessions to culminate into strengthened dyadic bonds. The exercise will also encourage participants to expand beyond the dyadic space to seek support from their communities, social networks and care services that are available to them.

Primary outcomes

  1. Change in well-being from baseline (patient)

    Time frame: 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.

  2. Change in well-being from baseline (caregiver only)

    Time frame: 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.

  3. Change in post-stroke reintegration from baseline (patient only)

    Time frame: 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.

  4. Change in caregiver burden from baseline (caregiver only)

    Time frame: 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.

  5. Change in self-efficacy from baseline (patient only)

    Time frame: 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 outcomes

  1. Changes in dyadic relationship interactions from baseline

    Time frame: 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.

  2. Change in spiritual well-being from baseline

    Time frame: 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).

  3. Change in anxiety and depression symptoms from baseline

    Time frame: 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.

  4. Changes in perception of social support from baseline

    Time frame: 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

  5. Change in resilience from baseline

    Time frame: 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.

  6. Change in hope from baseline

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andy HY Ho, PhD, EdD

CONTACT

[email protected]

+65 6316 8943

Shaik Muhammad Amin, MSc

CONTACT

[email protected]

+65 94797633

Sponsors and collaborators

Lead sponsor

Nanyang Technological University

Other

Collaborators

  • Tan Tock Seng Hospital

Registry information

Official study title

Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Evaluation of Psychosocial Recovery in First-Time Stroke Survivors and Family Caregivers

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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