The Peer Support Study

NCT05070624 | Completed

• 1 other identifier: CTO-3590
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Caregiver Competency - measured using the Caregiving Competence Scale

  Baseline

• Caregiver Competency - measured using the Caregiving Competence Scale

  12 week

• Caregiver Competency - measured using the Caregiving Competence Scale

  24 week

• Family Caregiver Burden and Stress - measured using the Zarit Burden Interview

  Baseline

• Family Caregiver Burden and Stress - measured using the Zarit Burden Interview

  12 week

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

The Virtual Peer Support Program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Criteria 1-3 above;
• Completion of virtual peer support training;
• Identified by the HMV team or self-referral.
• We will exclude those VAIs and caregivers, who are:
• Unable to communicate verbally in English
• No access to internet and computer/tablet.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Reshma Amin, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: September 15, 2022
• Primary Completion: August 28, 2024
• Study Completion: December 30, 2024
• Last Updated: May 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)