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

NCT03376711 | Unknown

• 1 other identifier: 32210
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Support; Affect; Ventilators, Mechanical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Feasibility: Participation rate

  12 weeks

• Feasibility: Participation frequency

  12 weeks

• Feasibility: Recruitment rates

  Through study completion, an average of 1 year

• Feasibility: Attrition

  12 weeks

• Change in Coping

  Change from baseline at 12 weeks

Study Arms (2)

Standard Care Group

NO INTERVENTION

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.

Online Peer Support Program

EXPERIMENTAL

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

Interventions

Online Peer Support Program BEHAVIORAL

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.

Online Peer Support Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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).

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Ventilator Equipment Pool (Queens University)

Kingston, Ontario, K7P 2Y5, Canada

RECRUITING

Study Officials

• Marina B Wasilewski, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Louise Rose, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina B Wasilewski, PhD

CONTACT

416-666-8732; marina.bastawrous@utoronto.ca

Louise Rose, PhD

CONTACT

416 978 3492; louise.rose@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: December 18, 2017
• Study Start: April 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: January 1, 2019
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)