Development & Pilot RCT of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals

Not Applicable

• Conditions: Social Support; Ventilators, Mechanical; Affect
• Interventions: Behavioral: Online Peer Support Program

• Registration Number: NCT03376711
• Lead Sponsor: University of Toronto

Brief Summary

Ventilator assisted individuals (VAIs) living at home are frail and generally cannot perform most daily activities. Although these individuals prefer to live at home, the family members who care for them often experience stress and poor health. Peer support can mitigate health declines by decreasing caregivers' isolation/stress and increasing their sense of control. However, no peer support programs are designed to meet these caregivers' complex and unique needs. Online support delivery is especially beneficial for caregivers given the geographic and time limitations they face. The proposed research aims to develop and conduct an RCT of online peer support program for VAI caregivers. A group of caregivers will be trained to act as peer mentors. This training program will be evaluated for its impact on caregivers' mentoring abilities. At the end of the 12-week program, caregiving participants will be asked about the online delivery of the program, how helpful/satisfactory it was, and if it affected their health and well-being. The health outcomes of the control and intervention group will be compared. This peer support program can improve the well-being of caregivers and allow them to better care for their family members.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-05-02
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-12
• Last Update Submitted: 2017-12-12
• Study First Posted: 2017-12-18
• Last Update Posted: 2017-12-18
• Primary Completion: 2018-08
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. age = 18 years; 2) primary family caregiver for a VAI living in the community; 3) able to speak and read English; and 4) access to a computer and a reliable internet connection.

Exclusion Criteria

1. currently experiencing severe depression as indicated by a score of 40 or higher on the Centre for epidemiological studies short depression scale (CES-D 10).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online Peer Support Program	Online Peer Support Program	Participants in the online peer support program arm of the intervention will have access to the website for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Positive and Negative Affect	Change from baseline at 12 weeks	Positive \& Negative Affect Scale (PANAS): 10 items \[Score: 10-50\]; higher scores indicate more psychological wellbeing

Secondary Outcome Measures

Name	Time	Method
Feasibility: Participation rate	12 weeks	Proportion of mentors and caregiving participants who contribute to weekly chats and discussion forums for all 12 weeks of the program
Feasibility: Participation frequency	12 weeks	Number of times that mentors and caregiving participants contribute to weekly chat and discussion forums over the course of 12 weeks. ).
Feasibility: Recruitment rates	Through study completion, an average of 1 year	Consent rate for participation (i.e. proportion of individuals approached who consent to participate)
Feasibility: Attrition	12 weeks	Attrition rates (i.e. number of mentors and caregiving participants who participate in entire peer support program and complete required study questionnaires).
Change in Coping	Change from baseline at 12 weeks	Brief Coping Orientations to Problems Experienced (COPE) Inventory: 28 items representing problem and emotion-based coping. Higher scores on either subscale represent greater use of that coping style
Change in Depression	Change from baseline at 12 weeks	) Centre for Epidemiological Studies Short Depression Scale (CES-D 10): 10 items \[Score: 0-30\]; higher scores sores indicate depression severity
Change in Caregiving Impact	Change from baseline at 12 weeks	Caregiving Impact Scale: 14 items \[Score: 0-84\]; higher scores suggest providing care interferes with caregivers' abilities to maintain participation in valued activities
Change in Mastery	Change from baseline at 12 weeks	Pearlin Mastery Scale: 7 items \[Score: 7-28\]; higher scores indicate a greater sense of control over life
Change in Personal Gain	Change from baseline at 12 weeks	Personal Gain Scale: 4 items \[Score: 4-16\]; higher scores indicate caregiver discovery of inner strengths due to providing care

Trial Locations

Locations (1)

Ventilator Equipment Pool (Queens University); 🇨🇦 Kingston, Ontario, Canada