Development & Pilot RCT of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03376711|
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
|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|
|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|
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.
- 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
- 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
- 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. ).
- 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)
- 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).
- 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
- 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
- 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
- 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
- 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
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
|Contact: Marina B Wasilewski, PhDfirstname.lastname@example.org|
|Contact: Louise Rose, PhD||416 978 email@example.com|
|Ventilator Equipment Pool (Queens University)||Recruiting|
|Kingston, Ontario, Canada, K7P 2Y5|
|Contact: Regina Pizutti, RRT 613-548-6156 firstname.lastname@example.org|
|Principal Investigator:||Marina B Wasilewski, PhD||University of Toronto|
|Principal Investigator:||Louise Rose, PhD||University of Toronto|