Condition or disease | Intervention/treatment | Phase |
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Sickle Cell Disease | Behavioral: iPeer2Peer Mentorship | Not Applicable |
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.
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 |
Actual Study Start Date : | January 1, 2020 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | March 2022 |
Arm | Intervention/treatment |
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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.
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Behavioral: iPeer2Peer Mentorship
Mentors and participants can have up to ten Skype calls over the course of 15 weeks.
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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.
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Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
United States, Connecticut | |
Connecticut Children's Medical Center | Recruiting |
Hartford, Connecticut, United States, 06106 | |
Contact: William Zempsky | |
Canada, Ontario | |
Children's Hospital of Eastern Ontario (CHEO) | Recruiting |
Ottawa, Ontario, Canada | |
Contact: Ewurabena Simpson | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada | |
Contact: Jennifer N Stinson, CPNP, PhD 416-813-7654 ext 304514 jennifer.stinson@sickkids.ca | |
Canada, Saskatchewan | |
Jim Pattison | Recruiting |
Saskatoon, Saskatchewan, Canada | |
Contact: Craig Eling |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 17, 2019 | ||||||||
First Posted Date ICMJE | June 18, 2019 | ||||||||
Last Update Posted Date | June 10, 2021 | ||||||||
Actual Study Start Date ICMJE | January 1, 2020 | ||||||||
Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | iPeer2Peer Program for Youth With Sickle Cell Disease | ||||||||
Official Title ICMJE | Peer-to-Peer (iP2P) Mentoring Program for Youth With Sickle Cell Disease: A Pilot Feasibility Randomized Controlled Trial | ||||||||
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. | ||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Sickle Cell Disease | ||||||||
Intervention ICMJE | Behavioral: iPeer2Peer Mentorship
Mentors and participants can have up to ten Skype calls over the course of 15 weeks.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
40 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 2022 | ||||||||
Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 18 Years (Child, Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03989986 | ||||||||
Other Study ID Numbers ICMJE | 1727 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Jennifer Stinson, The Hospital for Sick Children | ||||||||
Study Sponsor ICMJE | The Hospital for Sick Children | ||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||
PRS Account | The Hospital for Sick Children | ||||||||
Verification Date | June 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |