Neuromuscular DiseasesNCT05070624

The Peer Support Study

A study testing The Virtual Peer Support Program in people with Neuromuscular Diseases, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Neuromuscular Diseases
What is being tested?: The Virtual Peer Support Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteCanada
Study dates: 15 Sep 2022to 30 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

FC of individual with NMD that lives in Canada;
Speaks and reads English;
Access to internet and computer/tablet.
Criteria 1-3 above;
Completion of virtual peer support training;
Identified by the HMV team or self-referral.

Who cannot join

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:
We will exclude those VAIs and caregivers, who are:
Unable to communicate verbally in English
No access to internet and computer/tablet.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: 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.

Conditions: Neuromuscular Diseases
Being tested: The Virtual Peer Support Program
Medical subject headings: Neuromuscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Virtual Peer Support ProgramBehavioural
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.

Study groups in NCT05070624
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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,
Measured: 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)
Measured: 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)
Measured: 24 week

Secondary outcomes (12)

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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202230 Dec 2024

First posted7 Oct 2021
Study start15 Sep 2022
Primary completion28 Aug 2024
Study completion30 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070624
Sponsor's protocol ID: CTO-3590
Status last verified: Sep 2025
First submitted: 27 Sep 2021
Last updated: 5 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Connecting Caregivers: A Randomized Controlled Trial to Evaluate Virtual Peer-Support for Family Caregivers of Individuals With Neuromuscular Disease
ClinicalTrials.gov ID: NCT05070624
Acronym / sponsor ID: CTO-3590
Conditions: Neuromuscular Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: The Hospital for Sick ChildrenUniversity, hospital or other
Study start: 15 Sep 2022 (actual)
Primary completion: 28 Aug 2024 (actual)
Study completion: 30 Dec 2024 (actual)
First posted: 7 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: The Virtual Peer Support ProgramAfter 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.
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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

FC of individual with NMD that lives in Canada;
Speaks and reads English;
Access to internet and computer/tablet.
Criteria 1-3 above;
Completion of virtual peer support training;

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Virtual Peer Support ProgramTraining: 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.	Behavioural	Intervention

Primary outcome

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,
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)
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)

12 secondary outcomes

Caregiver Competency - measured using the Caregiving Competence Scale
Time frame: Baseline
Caregiver Competency - measured using the Caregiving Competence Scale
Time frame: 12 week
Caregiver Competency - measured using the Caregiving Competence Scale
Time frame: 24 week
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
Time frame: 12 week
Family Caregiver Burden and Stress - measured using the Zarit Burden Interview
Time frame: 24 week
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 Stress Scale
Time frame: 12 week
Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale
Time frame: 24 week
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.
Time frame: 12 week
Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
Time frame: 24 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Individual participant dataSharing planned: No

Related trials for Neuromuscular Diseases

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Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruitingObservational study
A Study of the Safety of Nusinersen (Spinraza®) and Its Effects on Motor Function in Koreans Living With SMA Treated During Their Usual Medical Care
Muscular Atrophy, Spinal
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Reshma Amin, MD principal investigator

The Hospital for Sick Children

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Virtual Peer Support Program in people with Neuromuscular Diseases, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05070624.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.