The Peer Support Study

Neuromuscular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05070624
• Other study ID #: CTO-3590
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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