Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03989986 |
Other study ID # |
1727 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
April 2024 |
Source |
The Hospital for Sick Children |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.