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iP2P Mentorship Program for Teen HF Patients (iP2P HF)

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iPeer2Peer Program
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Peer Support Mentorship, Pediatrics, Adherence, Cardiomyopathy

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Mentee inclusion criteria: heart failure patient, at least 4 months post-diagnosis, between the ages of 12 and 17 years, able to speak and read English, and 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: heart failure patient, between the ages of 18 and 25 years, able to speak and read English, nominated by a member of their health care team as a good mentor based on maturity and emotional stability, 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), good communication skills (as assessed by a healthcare provider), and previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset. Exclusion Criteria: significant cognitive impairments as assessed by a qualified healthcare provider, 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 participating in other peer support or self-management interventions.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iPeer2Peer Program

Standard of Care Waitlist Control Group

Arm Description

Outcomes

Primary Outcome Measures

Acceptability (Mentees)
Whether the innovation is agreeable, palatable or satisfactory
Acceptability (Mentors)
Whether the innovation is agreeable, palatable or satisfactory
Adoption (Mentees)
The intention, initial decision or action to try or use an innovation
Adoption (Mentors)
The intention, initial decision or action to try or use an innovation
Feasibility (Mentees)
The extent to which an innovation can be used or carried out successfully in a given setting
Feasibility (Mentors)
The extent to which an innovation can be used or carried out successfully in a given setting
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
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
Level of engagement (Mentees)
Level of engagement (Mentors)

Secondary Outcome Measures

Disease self-management skills (Mentees)
Adherence (Mentees)
Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale
Quality of life (Mentees)
Perceived social support (Mentees)
Emotional distress (Mentees)
Resiliency (Mentees)
Assessment of mentor quality (Mentees)
Physical and emotional symptoms (Mentors)
Perceived social role satisfaction (Mentors)
Self-efficacy (Mentors)

Full Information

First Posted
January 24, 2023
Last Updated
April 12, 2023
Sponsor
The Hospital for Sick Children
Collaborators
University of Alberta/Stollery Children's Hospital, British Columbia Children's Hospital, The Centre Hospitalier Universitaire Sainte-Justine
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1. Study Identification

Unique Protocol Identification Number
NCT05709132
Brief Title
iP2P Mentorship Program for Teen HF Patients
Acronym
iP2P HF
Official Title
Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
April 13, 2027 (Anticipated)
Study Completion Date
April 13, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
University of Alberta/Stollery Children's Hospital, British Columbia Children's Hospital, The Centre Hospitalier Universitaire Sainte-Justine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Peer Support Mentorship, Pediatrics, Adherence, Cardiomyopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Waitlist randomized controlled trial
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iPeer2Peer Program
Arm Type
Experimental
Arm Title
Standard of Care Waitlist Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
iPeer2Peer Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability (Mentees)
Description
Whether the innovation is agreeable, palatable or satisfactory
Time Frame
15 weeks after baseline/immediately after the intervention
Title
Acceptability (Mentors)
Description
Whether the innovation is agreeable, palatable or satisfactory
Time Frame
Study completion, an average of 1 year
Title
Adoption (Mentees)
Description
The intention, initial decision or action to try or use an innovation
Time Frame
Baseline to 12 weeks post-program completion
Title
Adoption (Mentors)
Description
The intention, initial decision or action to try or use an innovation
Time Frame
Baseline to study completion, an average of 1 year
Title
Feasibility (Mentees)
Description
The extent to which an innovation can be used or carried out successfully in a given setting
Time Frame
Baseline to 12 weeks post-program completion
Title
Feasibility (Mentors)
Description
The extent to which an innovation can be used or carried out successfully in a given setting
Time Frame
Baseline to study completion, an average of 1 year
Title
Appropriateness (Mentees)
Description
The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Time Frame
Baseline to 12 weeks post-program completion
Title
Appropriateness (Mentors)
Description
The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem
Time Frame
Baseline to study completion, an average of 1 year
Title
Level of engagement (Mentees)
Time Frame
15 weeks after baseline/immediately after the intervention
Title
Level of engagement (Mentors)
Time Frame
Study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Disease self-management skills (Mentees)
Time Frame
Baseline to 12 weeks post-program completion
Title
Adherence (Mentees)
Description
Clinic attendance, completion of scheduled tests and procedures, and adolescent medication barriers scale
Time Frame
Baseline to 12 weeks post-program completion
Title
Quality of life (Mentees)
Time Frame
Baseline to 12 weeks post-program completion
Title
Perceived social support (Mentees)
Time Frame
Baseline to 12 weeks post-program completion
Title
Emotional distress (Mentees)
Time Frame
Baseline to 12 weeks post-program completion
Title
Resiliency (Mentees)
Time Frame
Baseline to 12 weeks post-program completion
Title
Assessment of mentor quality (Mentees)
Time Frame
15 weeks after baseline/immediately after the intervention
Title
Physical and emotional symptoms (Mentors)
Time Frame
Baseline to study completion, an average of 1 year
Title
Perceived social role satisfaction (Mentors)
Time Frame
Baseline to study completion, an average of 1 year
Title
Self-efficacy (Mentors)
Time Frame
Baseline to study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Mentee inclusion criteria: heart failure patient, at least 4 months post-diagnosis, between the ages of 12 and 17 years, able to speak and read English, and 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: heart failure patient, between the ages of 18 and 25 years, able to speak and read English, nominated by a member of their health care team as a good mentor based on maturity and emotional stability, 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), good communication skills (as assessed by a healthcare provider), and previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset. Exclusion Criteria: significant cognitive impairments as assessed by a qualified healthcare provider, 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 participating in other peer support or self-management interventions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha J Anthony, PhD
Phone
416-813-7654
Ext
303126
Email
samantha.anthony@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Izabelle Siqueira, MPH
Email
izabelle.siqueira@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha J Anthony, PhD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha J Anthony, PhD
Phone
416-813-7654
Ext
303126
Email
samantha.anthony@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Samantha J Anthony, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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iP2P Mentorship Program for Teen HF Patients

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