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History of Changes for Study: NCT03431935
Predictors and Outcomes in Patients With Sickle Cell Disease
Latest version (submitted July 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 7, 2018 None (earliest Version on record)
2 February 14, 2018 Recruitment Status, Study Status, Contacts/Locations and Outcome Measures
3 March 1, 2018 Study Status
4 April 3, 2018 Study Status
5 May 3, 2018 Study Status
6 June 4, 2018 Study Status
7 June 15, 2018 Study Status and Study Description
8 July 9, 2018 Study Status
9 August 8, 2018 Study Status
10 July 29, 2019 Study Status
11 March 31, 2020 Recruitment Status, Study Status and Contacts/Locations
12 February 10, 2021 Recruitment Status, Study Status and Contacts/Locations
13 February 11, 2022 Study Status
14 July 8, 2022 Study Status
Comparison Format:

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Study NCT03431935
Submitted Date:  February 7, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: LEAPS
Brief Title: Predictors and Outcomes in Patients With Sickle Cell Disease
Official Title: Longitudinal Examination of Predictors and Outcomes of Sickle Cell Disease Healthcare Transition
Secondary IDs: K01HL125495-01A1 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: February 2018
Overall Status: Not yet recruiting
Study Start: February 2018
Primary Completion: February 2022 [Anticipated]
Study Completion: February 2022 [Anticipated]
First Submitted: February 7, 2018
First Submitted that
Met QC Criteria:
February 7, 2018
First Posted: February 13, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
February 7, 2018
Last Update Posted: February 13, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: St. Jude Children's Research Hospital
Responsible Party: Sponsor
Collaborators: Methodist Comprehensive Sickle Cell Center
University of Memphis
National Heart, Lung, and Blood Institute (NHLBI)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

Children with sickle cell disease (SCD) are living longer with the advent of medical advances such as prophylactic penicillin, chronic transfusion, and hydroxyurea. Despite greater longevity in SCD, the period following the transition from pediatric to adult care is critical; youth aged 18-30 years are at high risk for mortality and have high rates of healthcare utilization, leading to high healthcare costs. As such, health care transition (HCT) programs have been created to prepare patients for adult-centered care and subsequently, improve health outcomes. However, very few programs have been evaluated for effectiveness in achieving optimal health outcomes in SCD. This paucity of program evaluation is attributed to a lack of identifiable predictors and outcomes.

Researchers at St. Jude Children's Research Hospital want to identify factors and patterns of successful HCT. This information will be used to develop approaches to best evaluate HCT interventions and identify areas of improvement of HCT programming.

PRIMARY OBJECTIVE: Describe hospital utilization, treatment adherence, and health-related quality of life in a cohort of patients with sickle cell disease (SCD) who will transfer to adult care during the study period.

SECONDARY OBJECTIVE: Examine the associations between various factors and health care transition (HCT) outcomes.

Detailed Description:

Participants will be asked to complete a set of questions during an outpatient clinic visit at St. Jude or Methodist Adult Comprehensive Sickle Cell Center. The questions ask about sickle cell disease knowledge and self-management skills, access to care, general adjustment, quality of life, and stress. These questions will take about 60 minutes to complete.

Participants will answer questionnaires on a password protected laptop or tablet using a computer program called Audio Computer-Assisted Self-Interviews (ACASI). The laptop or tablet will be kept by the study team. A study team member will be available during this time to address any technical issues or answer any questions. Participants will answer one of the questionnaires verbally, and the study team member will record responses from the questionnaire with paper and pen. Study members will meet five times with each participant during regularly-scheduled clinical visits over a two year period.

Two institutions will collaborate in the proposed project. St. Jude Children's Research Hospital (St. Jude) and the Methodist Comprehensive Sickle Cell Center will be the primary source of participants. Faculty from the University of Memphis, Department of Psychology, will be involved in methodological considerations and analyzing the data.

Open or close this module Conditions
Conditions: Sickle Cell Disease
Keywords: Health Care Transition
Adolescent
Young Adult
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 146 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of emergency room/hospital admissions in the previous 12 months
[ Time Frame: Once, at age 19 ]

The primary objective will utilize data collected at age 19 years, 0 months (±2 months), the age participants will have transferred to adult care. This data will come from participants enrolled between the ages of 17 years, 0 months and 19 years, 0 months.
2. Percent of clinic visits completed in the previous 12 months
[ Time Frame: Once, at age 19 ]

The primary objective will utilize data collected at age 19 years, 0 months (±2 months), the age participants will have transferred to adult care. This data will come from participants enrolled between the ages of 17 years, 0 months and 19 years, 0 months.
3. Percent hydroxyurea prescription refill rate
[ Time Frame: Once, at age 19 ]

The primary objective will utilize data collected at age 19 years, 0 months (±2 months), the age participants will have transferred to adult care. This data will come from participants enrolled between the ages of 17 years, 0 months and 19 years, 0 months.
4. Health-related quality of life
[ Time Frame: Once, at age 19 ]

The primary objective will utilize data collected at age 19 years, 0 months (±2 months), the age participants will have transferred to adult care. This data will come from participants enrolled between the ages of 17 years, 0 months and 19 years, 0 months.
Open or close this module Eligibility
Study Population: Participants who meet eligibility criteria and have a pre-existing relationship as a patient at St. Jude Children's Research Hospital.
Sampling Method: Non-Probability Sample
Minimum Age: 16 Years
Maximum Age: 20 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Diagnosis of sickle cell disease (all genotypes).
  • Age 16.0 - 20.99 years at initial assessment.
  • Primary language is English.

Exclusion Criteria:

  • Participant unable to complete the questionnaires due to refusal, current acute illness (e.g., pain crisis), or significant cognitive impairment as judged by health care providers at the SCD clinic.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Open or close this module Contacts/Locations
Central Contact Person: Jerlym Porter, PhD, MPH
Telephone: 866-278-5833
Email: referralinfo@stjude.org
Study Officials: Jerlym Porter, PhD, MPH
Principal Investigator
St. Jude Children's Research Hospital
Locations: United States, Tennessee
Methodist Adult Comprehensive Sickle Cell Center
Memphis, Tennessee, United States, 38104
Contact:Contact: Jerlym Porter, PhD, MPH 901-595-4357 referralinfo@stjude.org
Contact:Principal Investigator: Jerlym Porter, PhD, MPH
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Contact:Contact: Jerlym Porter, PhD, MPH 866-278-5833 referralinfo@stjude.org
Contact:Principal Investigator: Jerlym Porter, PhD, MPH
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: St. Jude Children's Research Hospital
Description: Clinical Trials Open at St. Jude
Description: Methodist Comprehensive Sickle Cell Center
Available IPD/Information:

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