Clinical trial NCT05070624: The Peer Support Study
Official title: Connecting Caregivers: A Randomized Controlled Trial to Evaluate Virtual Peer-Support for Family Caregivers of Individuals With Neuromuscular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Diseases
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS)
timeFrame: baseline
measure: Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks
timeFrame: 12 week
measure: Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks
timeFrame: 24 week
Secondary outcomes:
measure: Caregiver Competency - measured using the Caregiving Competence Scale
timeFrame: Baseline
measure: Caregiver Competency - measured using the Caregiving Competence Scale
timeFrame: 12 week
measure: Caregiver Competency - measured using the Caregiving Competence Scale
timeFrame: 24 week
measure: Family Caregiver Burden and Stress - measured using the Zarit Burden Interview
timeFrame: Baseline
measure: Family Caregiver Burden and Stress - measured using the Zarit Burden Interview
timeFrame: 12 week
measure: Family Caregiver Burden and Stress - measured using the Zarit Burden Interview
timeFrame: 24 week
measure: Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale
timeFrame: Baseline
measure: Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale
timeFrame: 12 week
measure: Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale
timeFrame: 24 week
measure: Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
timeFrame: Baseline
measure: Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
timeFrame: 12 week
measure: Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
timeFrame: 24 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Reshma Amin, MD
role: PRINCIPAL_INVESTIGATOR
References: