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

September 11, 2024 updated by: Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pre-Post ARCH Intervention
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.
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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
The Zarit Burden Interview Short (ZBI-Short) is a 12-item questionnaire that assesses caregiver burden on a 4-point scale.
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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).
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
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.
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
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
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
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanyang Technological University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-2023-00-355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Pre-Post ARCH Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings