A Self-Management Intervention for Youth With Sickle Cell Disease and Their Families: Phase I

Study Overview
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Brief Summary
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This study is being conducted to test an intervention for children and adolescents ages 8-17 years with sickle cell disease and their families. In the first phase of this study, key informant interviews are being conducted with health care providers and children ages 8-17 with sickle cell disease and their primary caregivers. Participants are asked to review the intervention and provide feedback that will inform revision to the intervention.

Detailed Description
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Key informant, semi-structured interviews are conducted using an interview guide to obtain expert provider (healthcare providers of children with SCD) and end-user (children and parents/caregivers) feedback on the intervention. Interview questions are designed to solicit information on advantages and disadvantages, perceived usefulness, and recommendations for improvement on the intervention. The interviews will last approximately 1 hour and are audio recorded. Recordings are transcribed for analysis. Data are analyzed using a deductive-inductive approach with the intervention as a framework for initial categories. Findings will inform revisions to the intervention. Feasibility testing of the revised intervention will be conducted in the next phase of the study.

Official Title
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Self Management for Families and Youth: Phase I

Conditions
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Anemia, Sickle Cell

Intervention / Treatment
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* Behavioral: SELFY (Self Management for Youth with SCD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 8-17 years and their primary caregiver Child with SCD as indicated by self/parent report or report from MUSC Pediatric Sickle Cell clinic staff Child has been seen at the MUSC Pediatric Sickle Cell clinic for at least 6 months MUSC Pediatric Sickle Cell clinic staff report preventive recommendations are followed by child/caregiver Health care providers: Age 18 years or older Healthcare professional with at least 6 months' experience caring for children with SCD Exclusion Criteria: Non-English speaking Inability or unwillingness to participate in a one-on-one interview Inability or unwillingness of parent/caregiver or health care provider to give informed consent and of child to give assent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: SELFY (Self Management for Youth with SCD)|The intervention will be delivered via a mobile device (tablet) and consists of three components. 1. Education, will consist of continuous access to electronic educational resources on the SCD process, treatment, home management strategies, symptom prevention and management strategies. To address potential literacy barriers, an application that reads PDF files aloud will be downloaded onto devices. 2. symptom monitoring and tracking, will consist of an application for tracking and monitoring pain in SCD that also permits upload of symptom logs and text alerts to a health care provider. 3. caregiver-provider communication, consists of SMS messaging with a nurse who will: respond to alerts, monitor pain symptoms delivered via the mHealth application, and respond to text messages.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-user perceptions of intervention using semi-structured, key informant interviews | Themes or categories developed from analysis of qualitative data on child/caregiver perceptions of the intervention. | through study completion, approximately one hour | 
| Expert provider perceptions of intervention using semi-structured, key informant interviews | Themes or categories developed from analysis of qualitative data on health care provider perceptions of the intervention. | through study completion, approximately one hour |