N/A
N=112
Sickle Cell Anemia WE CARE
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT03716726 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Emergency Department (ED)/Acute Care Visits — 0; 1 number of visits
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WE CARE SDoH Screening Survey (Behavioral); Family Resource Book (Behavioral); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Emergency Department (ED)/Acute Care Visits |
0; 1 | — |
| PRIMARY Parental Enrollment in Community Resources |
9; 11; 1; 2; 1; 0 | — |
| SECONDARY Personal Health Questionnaire Depression Scale (PHQ-8) |
28; 25; 1; 3; 1; 0 | — |
| SECONDARY Brief COPE (Coping Orientation to Problems Experienced Inventory) at 12 Months |
2; 3.5; 4; 5; 2; 2 | — |
| SECONDARY Vaso-occlusive Episodes |
1; 1 | — |
| SECONDARY Prescriptions for Sickle Cell Disease |
365; 196; 365; 258 | — |
| SECONDARY Hemoglobin Values Related to Medication Adherence |
9.3; 8.8 | — |
| SECONDARY White Blood Cell and Absolute Neutrophil Counts Related to Medication Adherence |
8.6; 9.0; 3.5; 3.4 | — |
| SECONDARY Mean Corpuscular Volume Values Related to Medication Adherence |
96; 90.1 | — |
Summary
This mixed-methods study aims to understand the implementation of a previously tested, efficacious social determinants of health (SDoH) screening and referral intervention in the outpatient pediatric hematology setting; qualitatively assess possible mechanisms for such interventions on improving child health; and obtain population-specific empirical estimates to plan a large-scale clinical trial.
Eligibility Criteria
Inclusion Criteria
- Adult parents of children with SCA (0-12 years of age) who take a daily medication (penicillin or hydroxyurea)to
- English or Spanish speaking
Exclusion Criteria
- Foster parents
Data sourced from ClinicalTrials.gov (NCT03716726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.