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

Study Overview
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Brief Summary
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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.

Official Title
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Development & Pilot Randomized Control Trial (RCT) of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals Living in the Community

Conditions
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Social Support, Affect, Ventilators, Mechanical

Intervention / Treatment
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* Behavioral: Online Peer Support Program


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care Group<br>Participants in this arm of the study will not have access to the online peer support program until the end of the 12-week trial. | |
| Experimental: Online Peer Support Program<br>Participants in the online peer support program arm of the intervention will have access to the website for 12 weeks. | Behavioral: Online Peer Support Program<br>* The online peer support program will entail: 1) Informational links; 2) A discussion forum (open to all participants and allowing for asynchronous contact between caregivers & peer mentors); 3) A weekly live chat; 4) Private messaging (audio, video, and text options); and 5) Ask-a-mentor (A short video/blurb profiling each caregiving mentor will be posted including details such as gender, age, duration of care, relationship to care-recipient, and illness that care-recipient suffers from). Caregiving participants can then self-match to a peer mentor they feel is best-positioned to address their support needs.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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