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

NCT ID: NCT03376711

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-01-31

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.

Detailed Description

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Conditions

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Social Support Affect Ventilators, Mechanical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Online Peer Support Program

Participants in the online peer support program arm of the intervention will have access to the website for 12 weeks.

Group Type EXPERIMENTAL

Online Peer Support Program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Louise Rose

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marina B Wasilewski, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Louise Rose, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Ventilator Equipment Pool (Queens University)

Kingston, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Marina B Wasilewski, PhD

Role: CONTACT

Phone: 416-666-8732

Email: [email protected]

Louise Rose, PhD

Role: CONTACT

Phone: 416 978 3492

Email: [email protected]

Facility Contacts

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Regina Pizutti, RRT

Role: primary

Other Identifiers

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32210

Identifier Type: -

Identifier Source: org_study_id