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

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

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.

Study Overview

• Status: Unknown
• Conditions: Social Support; Affect; Ventilators, Mechanical
• Intervention / Treatment: Behavioral: Online Peer Support Program

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina B Wasilewski, PhD; Phone Number: 416-666-8732; Email: marina.bastawrous@utoronto.ca
• Study Contact Backup: Name: Louise Rose, PhD; Phone Number: 416 978 3492; Email: louise.rose@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7P 2Y5
      • Recruiting
      • Ventilator Equipment Pool (Queens University)
      • Contact: Regina Pizutti, RRT; Phone Number: 613-548-6156; Email: pizzutir@kgh.kari.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care Group; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Marina B Wasilewski, PhD, University of Toronto; Principal Investigator: Louise Rose, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 32210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No