Adolescent, Caregiver, and Young Adult Perspectives of the Transition From Pediatric to Adult Care for Sickle Cell Disease: A Preliminary Evaluation of the Sickle Cell Disease Transition Program

Sickle Cell Disease Clinical Trial

Official title:

Adolescent, Caregiver, and Young Adult Perspectives of the Transition From Pediatric to Adult Care for Sickle Cell Disease: A Preliminary Evaluation of the Sickle Cell Disease Transition Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569971
• Other study ID #: XPD12-025 TRANSCD
• Secondary ID: U1EMC19331
• Status: Completed
• Phase: N/A
• First received: March 30, 2012
• Last updated: June 23, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Sickle cell disease (SCD) is a debilitating genetic disorder affecting 70,000-100,000 Americans. It is frequently associated with very serious medical complications. For children with SCD, successfully transitioning to adult care is a vital step in ensuring continuity of care, managing their disease, and improving their health outcomes. Transition programs have been created to facilitate the transition process. However, few studies have assessed transition readiness and whether transition program components meet the transition needs of patients and families.

The purpose of this study is to explore transitioning from pediatric care to adult care and to assess components of the SJCRH SCD Transition Program from three perspectives: adolescents with SCD, their caregivers, and young adults with SCD who have transitioned to adult care. Data collection methods will include focus groups, questionnaires, and checklists. Qualitative data analysis procedures will be used to examine the data.

Description:

In this study, through the use of focus groups and questionnaires, we will identify perceptions of transition from pediatric to adult care, transition readiness, disease knowledge, and self-management skills, and assess components of the St. Jude Children's Research Hospital (SJCRH) Sickle Cell Disease Transition Program. Participants will participate in focus groups to discuss transition and transition-related concepts and evaluate components of the transition program. Additionally, participants will complete questionnaires about specific aspects of the transition program and about current disease knowledge and management skills.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

• Adolescents with SCD (all genotypes) ages = 12 years old and = 18 years old and currently receiving services through the SJCRH Sickle Cell Disease Transition Program.

• Caregivers who have resided with the adolescent with SCD for at least 2 years prior.

• Young adults with SCD (all genotypes) ages = 18 years old and = 30 years old who have transitioned to adult care

Exclusion Criteria:

• Non-English speakers.

• Adolescents and young adults with sickle cell trait.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• Assessment
In this study, through the use of focus groups and questionnaires, we will identify perceptions of transition from pediatric to adult care, transition readiness, disease knowledge, and self-management skills, and assess components of the St. Jude Children's Research Hospital (SJCRH) Sickle Cell Disease Transition Program. Participants will participate in focus groups to discuss transition and transition-related concepts and evaluate components of the transition program. Additionally, participants will complete questionnaires about specific aspects of the transition program and about current disease knowledge and management skills.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Health Resources and Services Administration (HRSA), Plough Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grounded theory qualitative analysis of data	First, data will be prepared for qualitative analysis. Digital audio files from the focus groups will be transcribed verbatim and questionnaire data will be entered into an Excel data file. Second, focus group data will be qualitatively analyzed using the constant comparative process. A qualitative data analysis program, NVivo9 (Victoria, Australia) will be used to assist with this coding process.	1 day	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital