Sickle Cell DiseaseNCT01569971
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
An observational study of Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Assessment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Non-English speakers.
- Adolescents and young adults with sickle cell trait.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Assessment
- Keywords
- Transition Program, Perspectives
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Also called Focus Groups, Questionnaires
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Assessment | |
| Caregivers | Caregiver of an adolescent with SCD who has resided with the adolescent for at least two years prior. Receives: Other: Assessment | |
| 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. Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Plough Foundation, Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Jerlym Porter, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569971
- Sponsor's protocol ID
- XPD12-025 TRANSCD
- Other IDs
- U1EMC19331
- Status last verified
- Jun 2014
- First submitted
- 30 Mar 2012
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01569971
- Acronym / sponsor ID
- XPD12-025 TRANSCD
- Conditions
- Sickle Cell Disease
- Keywords
- Transition Program, Perspectives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Plough Foundation, Health Resources and Services Administration (HRSA)
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | Other: AssessmentAdolescents 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. |
| Caregivers | – | Other: AssessmentCaregiver of an adolescent with SCD who has resided with the adolescent for at least two years prior. |
| Young Adults | – | Other: AssessmentYoung 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. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English speakers.
- Adolescents and young adults with sickle cell trait.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentAlso: Focus Groups, QuestionnairesIn 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 | Adolescents, Caregivers, Young Adults |
Primary outcome
Grounded theory qualitative analysis of data
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerlym Porter, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grounded theory qualitative analysis of data (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.