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Completed

NCT Number: NCT05070624

The Peer Support Study

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.

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Key information

Conditions

Neuromuscular Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS)

    Time frame: baseline

    FC mastery measured using the Pearlin Mastery Scale (PMS) (Pearlin Mastery Scale;(scores range up to 28, higher scores = higher mastery) at baseline,

  2. Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks

    Time frame: 12 week

    (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks (Pearlin Mastery Scale; (scores range up to 28, higher scores = higher mastery)

  3. Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks

    Time frame: 24 week

    (FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks (Pearlin Mastery Scale; (scores range up to 28, higher scores = higher mastery)

Secondary outcomes

  1. Caregiver Competency - measured using the Caregiving Competence Scale

    Time frame: Baseline

    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

  2. Caregiver Competency - measured using the Caregiving Competence Scale

    Time frame: 12 week

    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

  3. Caregiver Competency - measured using the Caregiving Competence Scale

    Time frame: 24 week

    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

  4. Family Caregiver Burden and Stress - measured using the Zarit Burden Interview

    Time frame: Baseline

    Family Caregiver Burden and Stress - measured using the Zarit Burden Interview (scores range up to 88, higher scores = higher burden)

  5. Family Caregiver Burden and Stress - measured using the Zarit Burden Interview

    Time frame: 12 week

    Family Caregiver Burden and Stress - measured using the Zarit Burden Interview scores range up to 88, higher scores = higher burden)

  6. Family Caregiver Burden and Stress - measured using the Zarit Burden Interview

    Time frame: 24 week

    Family Caregiver Burden and Stress - measured using the Zarit Burden Interview scores range up to 88, higher scores = higher burden)

  7. Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale

    Time frame: Baseline

    Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale

  8. Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale

    Time frame: 12 week

    Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale

  9. Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale

    Time frame: 24 week

    Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale

  10. Family Caregiver Experience of the virtual peer support explored using qualitative interviews.

    Time frame: Baseline

    Family Caregiver Experience of the virtual peer support explored using qualitative interviews.

  11. Family Caregiver Experience of the virtual peer support explored using qualitative interviews.

    Time frame: 12 week

    Family Caregiver Experience of the virtual peer support explored using qualitative interviews.

  12. Family Caregiver Experience of the virtual peer support explored using qualitative interviews.

    Time frame: 24 week

    Family Caregiver Experience of the virtual peer support explored using qualitative interviews.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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