Social SupportNCT03376711
Development & Pilot RCT of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals
A study testing Online Peer Support Program in people with Social Support and Affect, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Support, Affect, Ventilators, Mechanical
- What is being tested?
- Online Peer Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2017to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ventilator Equipment Pool (Queens University)
Kingston, Ontario, K7P 2Y5
Regina Pizutti, RRT, 613-548-6156, pizzutir@kgh.kari.net
About this study
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
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
- Being tested
- Online Peer Support Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Peer Support ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Peer Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Affect
Positive \& Negative Affect Scale (PANAS): 10 items [Score: 10-50]; higher scores indicate more psychological wellbeing
Measured: Change from baseline at 12 weeks
Secondary outcomes (9)
Feasibility: Participation rate
Proportion of mentors and caregiving participants who contribute to weekly chats and discussion forums for all 12 weeks of the program
Measured: 12 weeks
Feasibility: Participation frequency
Number of times that mentors and caregiving participants contribute to weekly chat and discussion forums over the course of 12 weeks. ).
Measured: 12 weeks
Feasibility: Recruitment rates
Consent rate for participation (i.e. proportion of individuals approached who consent to participate)
Measured: Through study completion, an average of 1 year
Feasibility: Attrition
Attrition rates (i.e. number of mentors and caregiving participants who participate in entire peer support program and complete required study questionnaires).
Measured: 12 weeks
Change in Coping
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
Measured: Change from baseline at 12 weeks
Change in Depression
) Centre for Epidemiological Studies Short Depression Scale (CES-D 10): 10 items [Score: 0-30]; higher scores sores indicate depression severity
Measured: Change from baseline at 12 weeks
Change in Caregiving Impact
Caregiving Impact Scale: 14 items [Score: 0-84]; higher scores suggest providing care interferes with caregivers' abilities to maintain participation in valued activities
Measured: Change from baseline at 12 weeks
Change in Mastery
Pearlin Mastery Scale: 7 items [Score: 7-28]; higher scores indicate a greater sense of control over life
Measured: Change from baseline at 12 weeks
Change in Personal Gain
Personal Gain Scale: 4 items [Score: 4-16]; higher scores indicate caregiver discovery of inner strengths due to providing care
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Apr 2017
- Primary completionAug 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social SupportStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Rose, University of Toronto
- Investigators
- Marina B Wasilewski, PhD, Principal investigator, University of TorontoLouise Rose, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376711
- Sponsor's protocol ID
- 32210
- Status last verified
- Dec 2017
- First submitted
- 2 May 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03376711
- Acronym / sponsor ID
- 32210
- Conditions
- Social Support, Affect, Ventilators, Mechanical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Online Peer Support ProgramParticipants in the online peer support program arm of the intervention will have access to the website for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Peer Support ProgramThe 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. | Behavioural | Online Peer Support Program |
Primary outcome
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
9 secondary outcomes
Feasibility: Participation rate
Time frame: 12 weeks
Feasibility: Participation frequency
Time frame: 12 weeks
Feasibility: Recruitment rates
Time frame: Through study completion, an average of 1 year
Feasibility: Attrition
Time frame: 12 weeks
Change in Coping
Time frame: Change from baseline at 12 weeks
Change in Depression
Time frame: Change from baseline at 12 weeks
Change in Caregiving Impact
Time frame: Change from baseline at 12 weeks
Change in Mastery
Time frame: Change from baseline at 12 weeks
Change in Personal Gain
Time frame: Change from baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina B Wasilewski, PhD principal investigator
University of Toronto
Louise Rose, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Peer Support Program in people with Social Support and Affect, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina B Wasilewski, PhD (416-666-8732, marina.bastawrous@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Affect (time frame: Change from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.