iPeer2Peer Program for Youth With Sickle Cell Disease

NCT03989986 | Active Not Recruiting

• 1 other identifier: 1727
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 4

Brief Summary

The iPeer2Peer Sickle Cell Disease (SCD) study matches youth (12-18 years of age) with SCD to a mentor (trained young adult) who has learned to manage their SCD well, transitioned to adult care, and can support youth participants emotionally and socially. Participants will be randomly assigned one of two groups, either (1) The intervention group: Study group participants are matched with a mentor for 15 weeks, and are expected to have up to ten calls with one another; (2) The control group: This study group will be on a 15 week waitlist to receive a mentor. This study will first assess the feasibility of conducting this research with youth with SCD. Also, this study will assess the preliminary effectiveness of peer mentorship by comparing various health outcomes of the two study groups post-intervention.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  The number of participants recruited for the study during the recruitment study period.

  2 years

• Rates of completion of mentor-mentee calls

  Compliance defined as 100% when a participant completes 10 calls within 15 weeks with their mentor

  15 weeks

• Withdrawal Rate

  Number of participants that withdraw from the study over the study period

  2 years

• Acceptability of iPeer2Peer SCD intervention

  Participants' perception regarding the acceptability of the SCD iP2P program and their level of engagement with the program (via a semi-structured interview).

  15 weeks

Secondary Outcomes (8)

• Sickle Cell Disease Pain Burden Interview- Youth

  Baseline and 15 weeks after baseline completion.

• Sickle Cell Disease Self-Efficacy Scale

  Baseline and 15 weeks

• PROMIS- Pediatric Peer Relationships 8a

  Baseline and 15 weeks

• PROMIS depressive symptoms - 8a

  Baseline and 15 weeks

• PROMIS anxiety - 8a

  Baseline and 15 weeks

Study Arms (2)

iPeer2Peer Mentorship

EXPERIMENTAL

In addition to standard care, participants in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modelling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with SCD aged 19-25 who have learned to function successfully with their condition). Mentors will encourage participants to develop and engage in self-management skills and provide social support.

Behavioral: iPeer2Peer Mentorship

Waitlist Control Group

NO INTERVENTION

The control group participants will receive standard care and will be on a waitlist to receive the iPeer2Peer program until 15 weeks after completing their baseline questionnaires.

Interventions

iPeer2Peer Mentorship BEHAVIORAL

Mentors and participants can have up to ten Skype calls over the course of 15 weeks.

iPeer2Peer Mentorship

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 12-18 years old
• Diagnosed with SCD by a haematologist
• Able to speak and read English
• Access to Internet connection with computer capable of using free Skype software
• Willing and able to complete online measures.

You may not qualify if:

• Significant cognitive impairments
• Major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQoL assessment
• Currently participating in other peer support or self-management interventions.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Children's Hospital of Eastern Ontario: collaborator
• Royal University Hospital Foundation: collaborator
• Connecticut Children's Medical Center: collaborator

Study Sites (4)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Jim Pattison

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

  PMID: 39382077 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 18, 2019
• Study Start: January 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CA (3); US (1)