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

Completed

• Conditions: Anemia, Sickle Cell

• Registration Number: NCT03069430
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States