Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Experimental Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNanyang Technological University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Pre-Post ARCH Intervention
BehavioralStroke 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Pre-Post ARCH InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in well-being from baseline (patient)
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.
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-intervention2
Change in well-being from baseline (caregiver only)
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.
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-intervention3
Change in post-stroke reintegration from baseline (patient only)
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.
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-intervention4
Change in caregiver burden from baseline (caregiver only)
The Zarit Burden Interview Short (ZBI-Short) is a 12-item questionnaire that assesses caregiver burden on a 4-point scale.
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-interventionSecondary outcomes
1
Changes in dyadic relationship interactions from baseline
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.
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-intervention2
Change in spiritual well-being from baseline
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).
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-intervention3
Change in anxiety and depression symptoms from baseline
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.
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-intervention4
Changes in perception of social support from baseline
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
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-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nanyang Technological University
Lead sponsor
Tan Tock Seng Hospital
Collaborator
Source ClinicalTrials.gov