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

This study has been completed.
Sponsor:
Collaborators:
Plough Foundation
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01569971
First received: March 30, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Sickle Cell Disease
Other: Assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Grounded theory qualitative analysis of data [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Enrollment: 55
Study Start Date: March 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescents
Adolescents with SCD (all genotypes) age 12 years old up to 18 years old and currently receiving services through the St. Jude Children's Research Hospital Sickle Cell Disease Transition Program.
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.
Other Names:
  • Focus Groups
  • Questionnaires
Caregivers
Caregiver of an adolescent with SCD who has resided with the adolescent for at least two years prior.
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.
Other Names:
  • Focus Groups
  • Questionnaires
Young Adults
Young adults with SCD (all genotypes) age equal to 18 years up to and equal to 30 years of age who have transitioned to adult care.
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.
Other Names:
  • Focus Groups
  • Questionnaires

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. 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
  2. Caregiver of an adolescent with SCD who has resided with the adolescent for at least 2 years prior
  3. Young adults with SCD (all genotypes) ages ≥ 18 years old and ≤ 30 years old who have transitioned to adult care
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569971

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Plough Foundation
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Jerlym Porter, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01569971     History of Changes
Other Study ID Numbers: XPD12-025 TRANSCD, U1EMC19331
Study First Received: March 30, 2012
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Transition Program
Perspectives

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 22, 2014