The Peer Support Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neuromuscular Diseases
• Intervention / Treatment: Behavioral: The Virtual Peer Support Program

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Munazzah Ambreen, MD.,MSc; Phone Number: 4164342542; Email: munazzah.ambreen@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Eligibility Criteria for Peer-Support Program:

Inclusion Criteria

1. FC of individual with NMD that lives in Canada;
2. Speaks and reads English;
3. Access to internet and computer/tablet.

Exclusion Criteria:

We will exclude those Ventilator Assisted Individuals (VAI) and caregivers, who are:

1. Unable to communicate verbally in English
2. No access to internet and computer/tablet.

Eligibility Criteria for Peer Mentors:

Inclusion Criteria:

1. Criteria 1-3 above;
2. Completion of virtual peer support training;
3. Identified by the HMV team or self-referral.

Exclusion Criteria:

We will exclude those VAIs and caregivers, who are:

1. Unable to communicate verbally in English
2. No access to internet and computer/tablet.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: CTO-3590

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