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

Affect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376711
• Other study ID #: 32210
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2017
• Last updated: December 12, 2017
• Start date: April 1, 2017
• Est. completion date: January 2019

Study information

• Verified date: December 2017
• Source: University of Toronto
• Contact: Marina B Wasilewski, PhD
• Phone: 416-666-8732
• Email: marina.bastawrous[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Affect
• Social Support
• Ventilators, Mechanical

Intervention

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.

Locations

Country	Name	City	State
Canada	Ventilator Equipment Pool (Queens University)	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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