The Peer Support Study

Study Overview
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Brief Summary
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Competent family caregivers (FC) are essential for successful caring for individuals with NMD. However, family caregiving is known to contribute to significant FC burden and social isolation, and negatively affects FC health. Infrastructure to support FCs is paramount to ensure that individuals with NMD can safely remain at home. Individuals with NMD have complex health problems, require a lot of care and they use the healthcare system often. COVID-19 physical distancing has increased the care burden and social isolation for many FCs. Infrastructure to support FCs is paramount to ensure that individuals with NMD can safely remain at home. Peer support includes emotional and informational support by an individual that has experienced a similar health problem. It improves health-related quality of life, increases self-efficacy and empowerment, and decreases stress in various patient and caregiver populations. With our study we plan to educate and empower individuals with NMD and their caregivers and develop a comprehensive peer support program.

Official Title
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Connecting Caregivers: A Randomized Controlled Trial to Evaluate Virtual Peer-Support for Family Caregivers of Individuals With Neuromuscular Disease

Conditions
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Neuromuscular Diseases

Intervention / Treatment
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* Behavioral: The Virtual Peer Support Program


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria for Peer-Support Program: Inclusion Criteria FC of individual with NMD that lives in Canada; Speaks and reads English; Access to internet and computer/tablet. Exclusion Criteria: We will exclude those Ventilator Assisted Individuals (VAI) and caregivers, who are: Unable to communicate verbally in English No access to internet and computer/tablet. Eligibility Criteria for Peer Mentors: Inclusion Criteria: Criteria 1-3 above; Completion of virtual peer support training; Identified by the HMV team or self-referral. Exclusion Criteria: We will exclude those VAIs and caregivers, who are: Unable to communicate verbally in English No access to internet and computer/tablet.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>After informed consent, we will assign participants in a 1:1 ratio to the intervention or control group using Randomize.net. Participants randomized to intervention group will get access to the Virtual Peer Support Program. | Behavioral: The Virtual Peer Support Program<br>* Training: We have previously developed and beta-tested a virtual peer mentor training program adapted from the St. Jude's Research Hospital's (Memphis, USA) program for FCs of children with cancer for adults using HMV. Content & Design of the Virtual Peer-Support Program: The program will be delivered by the aTouchAway™ App used for the LIVE program. Participants will be requested to access peer mentors ≥1 time/week. Participants can choose to interact with a peer mentor which will be assigned as well as other peer participants. Onboarding: Participants and mentors will create a personal profile of their caregiving situation (e.g., duration of care, family member age and diagnosis), to enable selection of mentors by the research team believed to be well suited to address support needs, questions, and concerns based on similar lived experience.<br>|
| No Intervention: Control<br>Control group: Those randomized to the waitlist control will be given access to the peer support intervention on completion of the first 12-week program. A waitlist control group is an ethical alternative to no-treatment control groups when studying psychological and behavioral interventions 21. will have access to informational resources via the aTouchAway™ App and will also receive the intervention at the end of the trial. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) | FC mastery measured using the Pearlin Mastery Scale (PMS) (Pearlin Mastery Scale;(scores range up to 28, higher scores = higher mastery) at baseline, | baseline | 
| Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks | (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks (Pearlin Mastery Scale; (scores range up to 28, higher scores = higher mastery) | 12 week | 
| Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks | (FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks (Pearlin Mastery Scale; (scores range up to 28, higher scores = higher mastery) | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Competency - measured using the Caregiving Competence Scale | Caregiver Competency - measured using the Caregiving Competence Scale, The total scores of this 4-item scale ranged from 4 to 16, with higher scores indicating higher levels of caregiving competence | Baseline | 
| Caregiver Competency - measured using the Caregiving Competence Scale | Caregiver Competency - measured using the Caregiving Competence Scale, The total scores of this 4-item scale ranged from 4 to 16, with higher scores indicating higher levels of caregiving competence | 12 week | 
| Caregiver Competency - measured using the Caregiving Competence Scale | Caregiver Competency - measured using the Caregiving Competence Scale, The total scores of this 4-item scale ranged from 4 to 16, with higher scores indicating higher levels of caregiving competence | 24 week | 
| Family Caregiver Burden and Stress - measured using the Zarit Burden Interview | Family Caregiver Burden and Stress - measured using the Zarit Burden Interview (scores range up to 88, higher scores = higher burden) | Baseline | 
| Family Caregiver Burden and Stress - measured using the Zarit Burden Interview | Family Caregiver Burden and Stress - measured using the Zarit Burden Interview scores range up to 88, higher scores = higher burden) | 12 week | 
| Family Caregiver Burden and Stress - measured using the Zarit Burden Interview | Family Caregiver Burden and Stress - measured using the Zarit Burden Interview scores range up to 88, higher scores = higher burden) | 24 week | 
| Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale | Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale | Baseline | 
| Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale | Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale | 12 week | 
| Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale | Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale | 24 week | 
| Family Caregiver Experience of the virtual peer support explored using qualitative interviews. | Family Caregiver Experience of the virtual peer support explored using qualitative interviews. | Baseline | 
| Family Caregiver Experience of the virtual peer support explored using qualitative interviews. | Family Caregiver Experience of the virtual peer support explored using qualitative interviews. | 12 week | 
| Family Caregiver Experience of the virtual peer support explored using qualitative interviews. | Family Caregiver Experience of the virtual peer support explored using qualitative interviews. | 24 week |