Clinical trial NCT03376711: Development & Pilot RCT of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Support
Affect
Ventilators, Mechanical
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Positive and Negative Affect
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Feasibility: Participation rate
timeFrame: 12 weeks
measure: Feasibility: Participation frequency
timeFrame: 12 weeks
measure: Feasibility: Recruitment rates
timeFrame: Through study completion, an average of 1 year
measure: Feasibility: Attrition
timeFrame: 12 weeks
measure: Change in Coping
timeFrame: Change from baseline at 12 weeks
measure: Change in Depression
timeFrame: Change from baseline at 12 weeks
measure: Change in Caregiving Impact
timeFrame: Change from baseline at 12 weeks
measure: Change in Mastery
timeFrame: Change from baseline at 12 weeks
measure: Change in Personal Gain
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Ventilator Equipment Pool (Queens University)
state: Ontario
Study officials:
affiliation: University of Toronto
name: Marina B Wasilewski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Louise Rose, PhD
role: PRINCIPAL_INVESTIGATOR
References: