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Predictors and Outcomes in Patients With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT03431935
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Methodist Comprehensive Sickle Cell Center
University of Memphis
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.


Condition or disease
Sickle Cell Disease

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. Questionnaires given verbally will be audio-recorded and reviewed by the lead researcher or other study team member. The recordings will be destroyed immediately after review. No transcript or written record of the recordings will be made. 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.


Study Type : Observational
Estimated Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Examination of Predictors and Outcomes of Sickle Cell Disease Healthcare Transition
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine





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 as assessed by the PedsQL [ 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.



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Ages Eligible for Study:   16 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who meet eligibility criteria and have a pre-existing relationship as a patient at St. Jude Children's Research Hospital.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431935


Contacts
Contact: Jerlym Porter, PhD, MPH 866-278-5833 referralinfo@stjude.org

Locations
United States, Tennessee
Methodist Adult Comprehensive Sickle Cell Center Recruiting
Memphis, Tennessee, United States, 38104
Contact: Jerlym Porter, PhD, MPH    901-595-4357    referralinfo@stjude.org   
Principal Investigator: Jerlym Porter, PhD, MPH         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Jerlym Porter, PhD, MPH    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Jerlym Porter, PhD, MPH         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Methodist Comprehensive Sickle Cell Center
University of Memphis
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jerlym Porter, PhD, MPH St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03431935     History of Changes
Other Study ID Numbers: LEAPS
K01HL125495-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Health Care Transition
Adolescent
Young Adult

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