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

Overview

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

• Behavioral Pre-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 c

Primary outcome measures

• 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]
• 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]
• 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]
• 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]
• 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]

Secondary outcome measures (6)

• 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]
• 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]
• 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]
• 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]
• 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]
• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Singapore · 1 center

• Tan Tock Seng Hospital — Singapore

Publications

• Choo PY, Shaik MA, Tan-Ho G, Lee J, Ho AHY. Living losses in stroke caregiving: A qualitative systematic review of systematic reviews on psycho-socio-emotional challenges and coping mechanisms. Int J Stroke. 2023 Mar;18(3):268-277. doi: 10.1177/17474930221104908. Epub 2022 Jul 5. PMID 35619566
• da Rocha NS, Power MJ, Bushnell DM, Fleck MP. The EUROHIS-QOL 8-item index: comparative psychometric properties to its parent WHOQOL-BREF. Value Health. 2012 May;15(3):449-57. doi: 10.1016/j.jval.2011.11.035. Epub 2012 Feb 9. PMID 22583455
• Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x. PMID 1430629
• Tang JY, Ho AH, Luo H, Wong GH, Lau BH, Lum TY, Cheung KS. Validating a Cantonese short version of the Zarit Burden Interview (CZBI-Short) for dementia caregivers. Aging Ment Health. 2016 Sep;20(9):996-1001. doi: 10.1080/13607863.2015.1047323. Epub 2015 May 27. PMID 26016419
• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. PMID 6880820
• Haver A, Akerjordet K, Caputi P, Furunes T, Magee C. Measuring mental well-being: A validation of the Short Warwick-Edinburgh Mental Well-Being Scale in Norwegian and Swedish. Scand J Public Health. 2015 Nov;43(7):721-7. doi: 10.1177/1403494815588862. Epub 2015 Jun 3. PMID 26041133
• Miller A, Clemson L, Lannin N. Measurement properties of a modified Reintegration to Normal Living Index in a community-dwelling adult rehabilitation population. Disabil Rehabil. 2011;33(21-22):1968-78. doi: 10.3109/09638288.2011.553707. Epub 2011 Feb 9. PMID 21306195
• Minshall C, Castle DJ, Thompson DR, Pascoe M, Cameron J, McCabe M, Apputhurai P, Knowles SR, Jenkins Z, Ski CF. A psychosocial intervention for stroke survivors and carers: 12-month outcomes of a randomized controlled trial. Top Stroke Rehabil. 2020 Dec;27(8):563-576. doi: 10.1080/10749357.2020.1738677. Epub 2020 Mar 19. PMID 32191569

Identifiers

NCT: NCT06596551 · IRB-2023-00-355

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗