- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07463014
Peer Enriched Environment for Recovery (PEER) (PEER)
Peer Enriched Environment for Recovery (PEER): An Integrated Health Coaching Intervention Post-Stroke
The goal of this interventional study is to assess whether a peer coaching intervention (PEER) can improve the well-being in individuals who experienced a stroke. The main questions it aims to answer are
- Is the PEER intervention feasible and acceptable for the intervention recipients who receive the intervention?
- Is the PEER intervention feasible and acceptable for the peer coaches who deliver the intervention?
- Do intervention recipients show a higher level of quality of life at immediate, 4-week, and 8-week post-intervention?
- Do intervention recipients display increases in measures of psycho-social-spiritual well-being at immediate, 4-week, and 8-week post-intervention? Peer coach participants will a) take training sessions, b) deliver 5 coaching sessions to an intervention recipient participant, c) complete surveys before training, after training, and after intervention delivery, and d) participate in a personal interview Intervention recipient participants will a) attend 5 coaching sessions delivered by a peer coach participant, b) complete surveys before intervention, immediately post intervention, 4-week post intervention, and 8 week post-intervention, and c) participate in a personal interview.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For intervention recipient recruitment, stroke survivors who have been diagnosed with stroke in the past 12 months and have been discharged from hospitals will be recruited from the collaborating community services and open recruitment. Recruited intervention recipients will proceed to take a baseline survey which collects their demographic characteristics, stroke-related information, wellbeing measures, and quality of life measure (T1). For peer coach recruitment, experienced stroke survivors who have been diagnosed with stroke in the past 5 years will be invited to participate in the study as peer coaches.
Recruited peer coaches will be asked to complete a preliminary survey. The preliminary survey collects peer coaches' demographic characteristics and stroke-related information, which will be sued for the matching between peer coaches and intervention recipients. The preliminary survey will also assess their well-being outcomes, QoL, self-determination level, coaching skills, and cognitive ability. Peer coaches with limited cognitive ability to perform peer-coaching will not proceed to peer coach training. Following the preliminary survey, peer coaches will undergo peer coach training sessions and the post-training assessment before performing peer-coaching in the intervention. The post-training assessment will include measurement of well-being outcomes, QoL, self-determination level, coaching skills, and cognitive ability. Peer coaches with limited cognitive ability to perform peer-coaching will not proceed to the intervention delivery.
Following the post-training survey, each peer coach will be matched with an intervention recipient based to their demographic characteristics and stroke experience. Following the matching process, peer coaches and intervention recipients will proceed into the intervention process. During the intervention, intervention recipients will be asked to attend peer-coaching sessions led by the matched peer coaches. The time of peer-coaching sessions will be decided based on participants' schedules. In the peer-coaching sessions, intervention recipients and peer coaches will meet in-person, and peer coaches will guide them to carry out arranged activities collaboratively. After the last peer coaching session is completed, intervention recipients will proceed to a post-intervention survey, which measures their satisfaction with the intervention as recipients, and a personal interviews, in which they will be asked about their perceptions and opinions on the PEER program. Intervention recipient will also be asked to take the follow-up survey at 3 time points - immediately after the intervention (T2), 4 weeks after the intervention (T3), and 8 weeks after the intervention (T4). The follow-up survey measures intervention recipients' wellbeing and quality of life. After the delivery of all peer coaching sessions, peer coaches will undergo the post-intervention survey, which assesses their well-being outcomes, QoL, self-determination level, cognitive ability, coaching skills, and satisfaction with the intervention as peer coaches; peer coaches will also be asked to attend a personal interview, in which they will be asked about their perceptions and opinions on the PEER program.
The interviews for peer coaches and intervention recipients will be audio-recorded with participants' consent. The recordings will be transcribed verbatim and proceed to thematic analyses. The analysis results of collected quantitative and qualitative data will be synthesized to evaluate the feasibility and the effectiveness of the peer-coaching intervention and the feasibility of the evaluation procedures. Elements of the PEER programme and the evaluation procedure will be improved based on the analysis results for future research and implementation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andy Hau Yan ho, PhD, EdD
- Phone Number: +65 80112011
- Email: andyhyho@ntu.edu.sg
Study Contact Backup
- Name: Farrah Dewanti, BSc
- Phone Number: +65 8355 6789
- Email: farrah.dewanti@ntu.edu.sg
Study Locations
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-
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Singapore, Singapore, 639798
- Recruiting
- Nanyang Technological University
-
Contact:
- Farrah Dewanti, BSc
- Phone Number: +65 8355 6789
- Email: farrah.dewanti@ntu.edu.sg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria for peer coach:
- Aged 21 years and above
- Diagnosed with stroke within the past 5 years and discharged from the hospital
Inclusion criteria for intervention recipients
- Aged 21 years and above
- Diagnosed with stroke within the past 1 year and discharged from the hospital
Exclusion criteria for all participants:
- Unable to communicate in English
- Unable to provide informed consent
- Diagnosed with one or multiple conditions which affect cognitive and/or mental health severely
- Diagnosed with severe or potentially terminal co-morbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Intervention recipient participants in this arm will undergo the peer coaching intervention to receive support from peer coaches
|
The PEER intervention is a post-stroke peer coaching intervention.
Participants who undergo this intervention will have 5 coaching sessions, which are delivered by trained peer coaches in-person.
In each session, peer coaches will practice psychoeducation, experience sharing, and interactive activity, to provide intervention recipients with psychosocial support.
Each coaching session will focus on a specific topic related to post-stroke recovery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental well-being of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Short Warwick Edinburgh Mental Well-being Scale (SWEMBS), a validated 7-item questionnaire designed to measure positive mental wellbeing with a 5-point Likert scale.
Scores of this scale range from 7 to 35, where higher scores indicate better mental well-being.
|
From enrollment to 8-week post intervention
|
|
Psychological distress of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Hospital Anxiety and Depression Scale (HADS), a widely used 14-item questionnaire designed to detect anxiety and depression.
Scores of this scale range from 0 to 21, where higher scores indicate higher levels of anxiety and depression.
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From enrollment to 8-week post intervention
|
|
Hope of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Herth Hope Index (HHI), a 12-item questionnaire developed to measure the level of hope.
Scores of this scale range from 12 to 84, where higher scores indicate greater levels of hope.
|
From enrollment to 8-week post intervention
|
|
Resilience of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Brief Resilience Scale (BRS), a 6-item measure designed to assess an individual's ability to bounce back or recover from stress, adversity, and challenging life circumstances.
Scores of this scale range from 6 to 30, where higher scores indicate more resilience and a better ability to bounce back from stress and adversity.
|
From enrollment to 8-week post intervention
|
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Stroke self-efficacy of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Stroke Self-Efficacy Questionnaire (SSEQ), a 13-item tool used to measure a stroke survivor's confidence in performing functional activities and managing their condition.
Scores of this scale range from 7 to 35, where higher scores indicate better mental well-being.
Scores of this scale range from 0 to 39, where higher scores indicate better self-efficacy.
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From enrollment to 8-week post intervention
|
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Reintegration of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Modified Reintegration to Normal Living Index (mRNLI), a validated 11-item assessment tool used to measure the degree to which individuals with chronic illnesses, disabilities, or traumatic injuries resume their normal social roles and activities.
Scores of this scale range from 0 to 110, where higher scores indicate higher, more satisfying levels of reintegration.
|
From enrollment to 8-week post intervention
|
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Social support of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Inventory of Social Support, a 5-item questionnaire developed to assess the level of social support.
Scores of this scale range from 5 to 25, where higher scores indicate higher levels of social support.
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From enrollment to 8-week post intervention
|
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Spiritual well-being of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Scale (FACIT-Sp-12), a widely used 12-item measure of spiritual wellbeing.
Scores of this scale range from 0 to 48, where higher scores indicate greater spiritual well-being.
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From enrollment to 8-week post intervention
|
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Stroke specific quality of life of intervention recipients
Time Frame: From enrollment to 8-week post intervention
|
This outcome will be assessed by the Stroke Specific Quality of Life Scale (SS-QOL), a 12-item questionnaire to assess health-related quality of life specifically for stroke survivors.
Scores of this scale range from 12 to 60, where higher scores indicate better function and greater quality of life.
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From enrollment to 8-week post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life of peer coach
Time Frame: Baseline, pre-intervention, immediately post-intervention
|
This secondary outcome will be assessed by the Single-Item Assessment of Quality of Life, an 1-item questionnaire to assess quality of life with a 10-point Likert scale.
Scores of this scale range from 0 to 10, where higher scores indicate greater quality of life.
|
Baseline, pre-intervention, immediately post-intervention
|
|
Life satisfaction of peer coach
Time Frame: Baseline, pre-intervention, immediately post-intervention
|
This secondary outcome will be assessed by the Single-Item Life Satisfaction Measure, an 1-item questionnaire designed to assess life satisfaction, with a 4-point Likert scale.
Scores of this scale range from 1 to 4, where higher scores indicate lower levels of life satisfaction.
|
Baseline, pre-intervention, immediately post-intervention
|
|
Spiritual well-being of peer coach
Time Frame: Baseline, pre-intervention, immediately post-intervention
|
This outcome will be assessed by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Scale (FACIT-Sp-12), a widely used 12-item measure of spiritual wellbeing.
Scores of this scale range from 0 to 48, where higher scores indicate greater spiritual well-being.
|
Baseline, pre-intervention, immediately post-intervention
|
|
Resilience of peer coach
Time Frame: Baseline, pre-intervention, immediately post-intervention
|
This outcome will be assessed by the Brief Resilience Scale (BRS), a 6-item measure designed to assess an individual's ability to bounce back or recover from stress, adversity, and challenging life circumstances.
Scores of this scale range from 6 to 30, where higher scores indicate more resilience and a better ability to bounce back from stress and adversity.
|
Baseline, pre-intervention, immediately post-intervention
|
|
Self determination of peer coach
Time Frame: Baseline, pre-intervention, immediately post-intervention
|
This secondary outcome will be assessed by the Self Determination Scale, a 10-item scale designed to assess individual differences in the extent to which people tend to function in a self-determined way.
Scores of this scale range from 10 to 50, where higher scores indicate higher levels of self determination.
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Baseline, pre-intervention, immediately post-intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2024-279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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