Predictors and Outcomes in Patients With Sickle Cell Disease

Status:	Recruiting
Conditions:	Anemia
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	16 - 20
Updated:	8/11/2018
Start Date:	July 31, 2018
End Date:	May 2022
Contact:	Jerlym Porter, PhD, MPH
Email:	referralinfo@stjude.org
Phone:	866-278-5833

Longitudinal Examination of Predictors and Outcomes of Sickle Cell Disease Healthcare Transition

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.

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.

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.

We found this trial at

sites

St. Jude Children's Research Hospital

262 Danny Thomas Pl
Memphis, Tennessee 38105

(901) 495-3300