iP2P Mentorship Program for Teen HF Patients

Heart Failure Clinical Trial

— iP2P HF  

Official title:

Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Failure Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709132
• Other study ID #: 1000080204
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: April 13, 2027

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: Samantha J Anthony, PhD
• Phone: 416-813-7654
• Email: samantha.anthony[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The iPeer2Peer (iP2P) program is an online peer support mentorship program that provides modelling and reinforcement by trained young adult peer mentors to adolescent mentees with the same condition. A waitlist hybrid implementation-effectiveness type 3 pilot randomized controlled trial design will be employed across four sites. We will recruit 40 mentees (12-17 years of age) and 12-15 mentors (18-25 years of age) who will undergo training in mentoring and the use of eHealth technology. Mentor-mentee pairings will connect over 15 weeks through video calls and text messaging to provide peer support and encourage disease self-management skills. Data will be collected using standardized instruments and interviews across three time points.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: April 13, 2027
• Est. primary completion date: April 13, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

Mentee inclusion criteria:

1. heart failure patient,

2. at least 4 months post-diagnosis,

3. between the ages of 12 and 17 years,

4. able to speak and read English, and

5. willingness to commit to 5-10 texts and/or calls of 20-30 minutes each with a peer mentor over a period of 15 weeks.

Mentor inclusion criteria:

1. heart failure patient,

2. between the ages of 18 and 25 years,

3. able to speak and read English,

4. nominated by a member of their health care team as a good mentor based on maturity and emotional stability,

5. willingness to commit to peer mentor training (20 hours) via the PHIPA-compliant version of Zoom or Microsoft Teams and mentoring adolescent participants (once paired with mentee, 5-10 texts and/or calls of 20-30 minutes over a period of 15 weeks),

6. good communication skills (as assessed by a healthcare provider), and

7. previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset.

Exclusion Criteria:

1. significant cognitive impairments as assessed by a qualified healthcare provider,

2. a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their heart failure care regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and

3. participating in other peer support or self-management interventions.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• iPeer2Peer Program
Behavioral: iPeer2Peer Support Mentorship Program iPeer2Peer is an online peer support mentorship program that has been established in multiple chronic disease populations as a self-management intervention, including chronic pain and juvenile idiopathic arthritis. The iPeer2Peer program provides modeling and reinforcement by pre-screened and trained young adult peer mentors to adolescent mentees.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	British Columbia Children's Hospital, The Centre Hospitalier Universitaire Sainte-Justine, University of Alberta/Stollery Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability (Mentees)	Whether the innovation is agreeable, palatable or satisfactory	15 weeks after baseline/immediately after the intervention
Primary	Acceptability (Mentors)	Whether the innovation is agreeable, palatable or satisfactory	Study completion, an average of 1 year
Primary	Adoption (Mentees)	The intention, initial decision or action to try or use an innovation	Baseline to 12 weeks post-program completion
Primary	Adoption (Mentors)	The intention, initial decision or action to try or use an innovation	Baseline to study completion, an average of 1 year
Primary	Feasibility (Mentees)	The extent to which an innovation can be used or carried out successfully in a given setting	Baseline to 12 weeks post-program completion
Primary	Feasibility (Mentors)	The extent to which an innovation can be used or carried out successfully in a given setting	Baseline to study completion, an average of 1 year
Primary	Appropriateness (Mentees)	The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem	Baseline to 12 weeks post-program completion
Primary	Appropriateness (Mentors)	The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem	Baseline to study completion, an average of 1 year
Primary	Level of engagement (Mentees)		15 weeks after baseline/immediately after the intervention
Primary	Level of engagement (Mentors)		Study completion, an average of 1 year
Secondary	Disease self-management skills (Mentees)		Baseline to 12 weeks post-program completion
Secondary	Adherence (Mentees)	Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale	Baseline to 12 weeks post-program completion
Secondary	Quality of life (Mentees)		Baseline to 12 weeks post-program completion
Secondary	Perceived social support (Mentees)		Baseline to 12 weeks post-program completion
Secondary	Emotional distress (Mentees)		Baseline to 12 weeks post-program completion
Secondary	Resiliency (Mentees)		Baseline to 12 weeks post-program completion
Secondary	Assessment of mentor quality (Mentees)		15 weeks after baseline/immediately after the intervention
Secondary	Physical and emotional symptoms (Mentors)		Baseline to study completion, an average of 1 year
Secondary	Perceived social role satisfaction (Mentors)		Baseline to study completion, an average of 1 year
Secondary	Self-efficacy (Mentors)		Baseline to study completion, an average of 1 year