search
Back to results

The Peer Support Study

Primary Purpose

Neuromuscular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The Virtual Peer Support Program
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neuromuscular Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria for Peer-Support Program:

Inclusion Criteria

  1. score of <10 on the Centre for Epidemiological Studies Short Depression (CESSD) scale during recruitment screening or score of ≥ 10 with referral to psychiatry/ social work with≥ 1 session completed and ongoing monitoring19 (score of ≥10 is cutoff for positive depression screen);
  2. FC of individual with NMD using HMV followed at 1 of the 8 HMV programs;
  3. speaks and reads English;
  4. currently using the aTouchAway™ App (Aetonix, Ottawa, Canada) in the LIVE program.

Exclusion Criteria:

We will exclude those Ventilator Assisted Individuals (VAI) and caregivers, who are:

(1) Unable to communicate verbally in English

Eligibility Criteria for Peer Mentors:

Inclusion Criteria:

  1. score of <10 on the Centre for Epidemiological Studies Short Depression (CESSD) scale;
  2. criteria 2-4 above;
  3. FC of an individual using HMV for ≥ 5 years;
  4. completion of virtual peer support training;
  5. identified by the HMV team or self-referral.

Exclusion Criteria:

We will exclude those VAIs and caregivers, who are:

(1) Unable to communicate verballyin English

Sites / Locations

  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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,
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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2021
Last Updated
June 29, 2023
Sponsor
The Hospital for Sick Children
search

1. Study Identification

Unique Protocol Identification Number
NCT05070624
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Virtual Peer Support Program
Intervention Description
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 Outcome Measure Information:
Title
Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS)
Description
FC mastery measured using the Pearlin Mastery Scale (PMS) (Pearlin Mastery Scale;(scores range up to 28, higher scores = higher mastery) at baseline,
Time Frame
baseline
Title
Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks
Description
(FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks (Pearlin Mastery Scale; (scores range up to 28, higher scores = higher mastery)
Time Frame
12 week
Title
Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks
Description
(FC) mastery measured using the Pearlin Mastery Scale (PMS) at 24 weeks (Pearlin Mastery Scale; (scores range up to 28, higher scores = higher mastery)
Time Frame
24 week
Secondary Outcome Measure Information:
Title
Caregiver Competency - measured using the Caregiving Competence Scale
Description
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
Time Frame
Baseline
Title
Caregiver Competency - measured using the Caregiving Competence Scale
Description
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
Time Frame
12 week
Title
Caregiver Competency - measured using the Caregiving Competence Scale
Description
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
Time Frame
24 week
Title
Family Caregiver Burden and Stress - measured using the Zarit Burden Interview
Description
Family Caregiver Burden and Stress - measured using the Zarit Burden Interview (scores range up to 88, higher scores = higher burden)
Time Frame
Baseline
Title
Family Caregiver Burden and Stress - measured using the Zarit Burden Interview
Description
Family Caregiver Burden and Stress - measured using the Zarit Burden Interview scores range up to 88, higher scores = higher burden)
Time Frame
12 week
Title
Family Caregiver Burden and Stress - measured using the Zarit Burden Interview
Description
Family Caregiver Burden and Stress - measured using the Zarit Burden Interview scores range up to 88, higher scores = higher burden)
Time Frame
24 week
Title
Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale
Description
Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale
Time Frame
Baseline
Title
Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale
Description
Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale
Time Frame
12 week
Title
Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety Stress Scale
Description
Family Caregiver Depression and Anxiety: measured using the Depression and Anxiety scores range up to 42, higher scores = higher depression and Anxiety)Stress Scale
Time Frame
24 week
Title
Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
Description
Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
Time Frame
Baseline
Title
Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
Description
Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
Time Frame
12 week
Title
Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
Description
Family Caregiver Experience of the virtual peer support explored using qualitative interviews.
Time Frame
24 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Munazzah Ambreen, MD.,MSc
Phone
4164342542
Email
munazzah.ambreen@sickkids.ca
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Chiang, MD
Phone
416-813-6346
Ext
206346
Email
jackie.chiang@sickkids.ca
Phone
416-813-7654
Ext
328361
First Name & Middle Initial & Last Name & Degree
Reshma Amin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Peer Support Study

We'll reach out to this number within 24 hrs