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

Self Management for Families and Youth: Phase I

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.

Study Overview

• Status: Completed
• Conditions: Anemia, Sickle Cell
• Intervention / Treatment: Behavioral: SELFY (Self Management for Youth with SCD)

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.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 15 parent/caregiver child dyads (30 individuals) and up to 15 healthcare providers will be recruited and enrolled in the study. No sex/gender or racial/ethnic group will be excluded. However, it is anticipated that the majority or all of the parent/caregiver child dyads will be African American since SCD is predominantly seen in this population. Pregnant women will not be excluded. Children ages 8-17 years will be recruited to participate in this study. Participation will include child-parent/caregiver dyads to solicit feedback from both groups and obtain a more comprehensive, family-level perspective on the intervention.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Shannon Phillips, PhD, RN, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): March 31, 2017
• Study Completion (ACTUAL): March 31, 2017

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (ACTUAL): March 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: Pro00057046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will only be available to study mentors and the biostatistician.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No