Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06596551
Enrollment
60
Registered
2024-09-19
Start date
2024-03-01
Completion date
2026-09-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Well-Being, Psychosocial Functioning, Stroke

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.

Interventions

BEHAVIORALPre-Post ARCH Intervention

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.

Sponsors

Tan Tock Seng Hospital
CollaboratorOTHER
Nanyang Technological University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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-interventionThe 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-interventionThe 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-interventionThe 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-interventionThe 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-interventionThe 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

MeasureTime frameDescription
Changes in dyadic relationship interactions from baselineParticipants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-interventionThe 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 hope from baselineParticipants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-interventionThe 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.
Change in spiritual well-being from baselineParticipants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-interventionThe 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 baselineParticipants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-interventionThe 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 baselineParticipants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-interventionThe 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 baselineParticipants will be assessed at four time points: [T1] baseline; [T2] immediately post-intervention; [T3] 3 months post-intervention; and [T4] 6 months post-interventionThe 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.

Countries

Singapore

Contacts

Primary ContactAndy HY Ho, PhD, EdD
andyhyho@ntu.edu.sg+65 6316 8943
Backup ContactShaik Muhammad Amin, MSc
shaikmuh002@e.ntu.edu.sg+65 94797633

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026