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

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ClinicalTrials.gov Identifier: NCT03376711
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Louise Rose, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Social Support Affect Ventilators, Mechanical Behavioral: Online Peer Support Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Change in Positive and Negative Affect [ Time Frame: Change from baseline at 12 weeks ]
    Positive & Negative Affect Scale (PANAS): 10 items [Score: 10-50]; higher scores indicate more psychological wellbeing


Secondary Outcome Measures :
  1. Feasibility: Participation rate [ Time Frame: 12 weeks ]
    Proportion of mentors and caregiving participants who contribute to weekly chats and discussion forums for all 12 weeks of the program

  2. Feasibility: Participation frequency [ Time Frame: 12 weeks ]
    Number of times that mentors and caregiving participants contribute to weekly chat and discussion forums over the course of 12 weeks. ).

  3. Feasibility: Recruitment rates [ Time Frame: Through study completion, an average of 1 year ]
    Consent rate for participation (i.e. proportion of individuals approached who consent to participate)

  4. Feasibility: Attrition [ Time Frame: 12 weeks ]
    Attrition rates (i.e. number of mentors and caregiving participants who participate in entire peer support program and complete required study questionnaires).

  5. Change in Coping [ Time Frame: Change from baseline at 12 weeks ]
    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

  6. Change in Depression [ Time Frame: Change from baseline at 12 weeks ]
    ) Centre for Epidemiological Studies Short Depression Scale (CES-D 10): 10 items [Score: 0-30]; higher scores sores indicate depression severity

  7. Change in Caregiving Impact [ Time Frame: Change from baseline at 12 weeks ]
    Caregiving Impact Scale: 14 items [Score: 0-84]; higher scores suggest providing care interferes with caregivers' abilities to maintain participation in valued activities

  8. Change in Mastery [ Time Frame: Change from baseline at 12 weeks ]
    Pearlin Mastery Scale: 7 items [Score: 7-28]; higher scores indicate a greater sense of control over life

  9. Change in Personal Gain [ Time Frame: Change from baseline at 12 weeks ]
    Personal Gain Scale: 4 items [Score: 4-16]; higher scores indicate caregiver discovery of inner strengths due to providing care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376711


Contacts
Contact: Marina B Wasilewski, PhD 416-666-8732 marina.bastawrous@utoronto.ca
Contact: Louise Rose, PhD 416 978 3492 louise.rose@utoronto.ca

Locations
Canada, Ontario
Ventilator Equipment Pool (Queens University) Recruiting
Kingston, Ontario, Canada, K7P 2Y5
Contact: Regina Pizutti, RRT    613-548-6156    pizzutir@kgh.kari.net   
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Marina B Wasilewski, PhD University of Toronto
Principal Investigator: Louise Rose, PhD University of Toronto

Responsible Party: Louise Rose, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03376711     History of Changes
Other Study ID Numbers: 32210
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No