Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

iPeer2Peer Program for Youth With Sickle Cell Disease

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: NCT03989986
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
Children's Hospital of Eastern Ontario
Royal University Hospital Foundation
Connecticut Children's Medical Center
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: iPeer2Peer Mentorship Not Applicable

Detailed Description:

Sickle Cell Disease (SCD) is a disease affecting red blood cells, where severe pain can develop due to blockage of red blood cells. This the most common genetic blood disease in North America, affecting mostly people of African descent. This type of pain can affect many aspects of one's life, and one's quality of life. Young people with SCD experience pain as they grow from childhood to adulthood, and experience daily chronic pain. There are many negative consequences of SCD, such as anxiety, depression, poor sleep, high stress, and limited social and physical activity. Peer support is a form of support that can provide someone with emotional, informational and social support. Peer support is a promising way of delivering emotional support, while helping someone learn how to cope and manage their disease. This is especially important for chronic diseases such as SCD, because young people will have to learn how to cope and manage their condition while growing up, and for the rest of their lives. A new way to provide face-to-face peer support is through the use of a virtual program using Skype via the Internet (to maintain face-to-face contact between mentors and mentees).

In this program, a young adult (a mentor) with a chronic disease is matched with a younger person living with the same disease (a mentee) online, through Skype. The mentors are nominated by their healthcare teams, and have successfully transitioned to adult care. They are trained to talk to young people about their disease and can give them some advice on how to manage, and grow up with the condition. This program has been tested with other groups with Juvenile Idiopathic Arthritis and Chronic Pain. A mentor and a mentee are matched for 15 weeks and are encouraged to have up to ten Skype calls together. The investigators do not know how well this program will work with young people with SCD. Therefore, the investigators would like to test out this program to see if it is feasible to conduct the iPeer2Peer SCD program in the future as a larger study with the SCD population.

Feasibility will be measured through the following: (1) recruitment and withdrawal rates; (2) rate of completion of weekly calls; (3) rate of completion of baseline measures; (4) estimates of intervention effects on health outcomes to inform the calculation of an appropriate sample size for the future definitive multi-centred randomized controlled trial (RCT) and (5) participants' perception regarding the acceptability of the SCD iP2P program and their level of engagement with the program (via a semi-structured interview). Descriptive statistics will be used to describe the sample characteristics at baseline. Rates of accrual, drop out, compliance, and missing data with 95% confidence intervals will be calculated.To inform sample size calculations and data analysis feasibility for a larger trial, data will be analyzed as in a larger study, and estimates of variance will be calculated. Secondary analysis will be conducted using an intent-to-treat approach. If assumptions for parametric statistics are met, linear regression models will be used to test intervention effects on pain impact, social support, self-efficacy, adherence and HRQL outcomes using an analysis of covariance approach with post-intervention measures compared between groups using baseline scores as covariates. The semi-structured individual (mentees) and focus group (mentors) interviews will determine (i) mentees' acceptability of and level of engagement in the iP2P program and (ii) mentors' likes and dislikes of program, improvement. This data, and subsequent analyses, will be used to refine the iP2P program prior to a full trial. A larger study will help to understand if peer support delivered by a mentor over Skype will help teenagers with SCD better manage their SCD, improve their health outcomes, and ultimately improve their quality of life living with SCD.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Peer-to-Peer (iP2P) Mentoring Program for Youth With Sickle Cell Disease: A Pilot Feasibility Randomized Controlled Trial
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: iPeer2Peer Mentorship
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
Mentors and participants can have up to ten Skype calls over the course of 15 weeks.

No Intervention: Waitlist Control Group
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.



Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: 2 years ]
    The number of participants recruited for the study during the recruitment study period.

  2. Rates of completion of mentor-mentee calls [ Time Frame: 15 weeks ]
    Compliance defined as 100% when a participant completes 10 calls within 15 weeks with their mentor

  3. Withdrawal Rate [ Time Frame: 2 years ]
    Number of participants that withdraw from the study over the study period

  4. Acceptability of iPeer2Peer SCD intervention [ Time Frame: 15 weeks ]
    Participants' perception regarding the acceptability of the SCD iP2P program and their level of engagement with the program (via a semi-structured interview).


Secondary Outcome Measures :
  1. Sickle Cell Disease Pain Burden Interview- Youth [ Time Frame: Baseline and 15 weeks after baseline completion. ]
    7-item questionnaire, measuring pain burden

  2. Sickle Cell Disease Self-Efficacy Scale [ Time Frame: Baseline and 15 weeks ]
    9-item questionnaire, measuring self-efficacy

  3. PROMIS- Pediatric Peer Relationships 8a [ Time Frame: Baseline and 15 weeks ]
    8-item questionnaire, measuring social support from peers

  4. PROMIS depressive symptoms - 8a [ Time Frame: Baseline and 15 weeks ]
    8-item questionnaire, measuring depression

  5. PROMIS anxiety - 8a [ Time Frame: Baseline and 15 weeks ]
    8-item questionnaire, measuring anxiety

  6. PROMIS Pain Interference - 8a [ Time Frame: Baseline and 15 weeks ]
    8-item questionnaire, measuring consequences of pain on relevant aspects of person's life.

  7. PROMIS pain intensity - 1a [ Time Frame: Baseline and 15 weeks ]
    1-item questionnaire, measuring intensity of pain over the past week

  8. Transition-Q [ Time Frame: Baseline and 15 weeks ]
    14-item questionnaire, measuring self-management



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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): NCT03989986


Contacts
Layout table for location contacts
Contact: Jennifer N Stinson, CPNP, PhD 416-813-7654 ext 304514 jennifer.stinson@sickkids.ca
Contact: Celia Cassiani, BSc, MSc 416-813-7654 ext 302313 celia.cassiani@sickkids.ca

Locations
Layout table for location information
United States, Connecticut
Connecticut Children's Medical Center Not yet recruiting
Hartford, Connecticut, United States, 06106
Contact: William Zempsky         
Canada, Ontario
Children's Hospital of Eastern Ontario (CHEO) Not yet recruiting
Ottawa, Ontario, Canada
Contact: Ewurabena Simpson         
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada
Contact: Jennifer N Stinson, CPNP, PhD    416-813-7654 ext 304514    jennifer.stinson@sickkids.ca   
Canada, Saskatchewan
Jim Pattison Not yet recruiting
Saskatoon, Saskatchewan, Canada
Contact: Craig Eling         
Sponsors and Collaborators
The Hospital for Sick Children
Children's Hospital of Eastern Ontario
Royal University Hospital Foundation
Connecticut Children's Medical Center

Layout table for additonal information
Responsible Party: Jennifer Stinson, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03989986     History of Changes
Other Study ID Numbers: 1727
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn