N/A
Completed N=30
Self-Management for Youth and Families Living With SCD - SMYLS
Source: ClinicalTrials.gov NCT03585543 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Apr 2020
Primary outcomePrimary: Rates of Recruitment — 14 weeks
Summary
The purpose of this proposal is to integrate family-centered self-management strategies with mobile health (mHealth) technology to improve reach, self-management behaviors, and child and caregiver physical and psychosocial symptoms and quality of life. Specifically, the investigators propose to conduct feasibility testing of SMYLS, which has been adapted based on user feedback in the first phase of this study. First the investigators will work with the Medical University of South Carolina (MUSC) Pediatric Sickle Cell Clinic to identify and recruit families with children with sickle cell disease (SCD) in the community, statewide. Next, the investigators will test the feasibility of the intervention with 30 dyads of children ages 8 - 17 with sickle cell disease and their parent or primary caregiver, (N=60)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Recruitment |
14 | — |
| PRIMARY Participant Adherence to Intervention |
12; 2; 1 | — |
| PRIMARY Acceptability of Intervention |
4 | — |
| SECONDARY Difference in Mean Pain Score Rating From Baseline to End-of-intervention |
-9.0 | — |
| SECONDARY Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention |
0.2 | — |
| SECONDARY Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention |
10.9 | — |
| SECONDARY Difference in Mean Scores for Fatigue From Baseline to End-of-intervention |
-7.9 | — |
| SECONDARY Difference in Mean Scores for Anxiety From Baseline to End-of-intervention |
1.6 | — |
| SECONDARY Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention |
-3.1 | — |
| SECONDARY Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention |
-1.9 | — |
| SECONDARY Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention |
12.5 | — |
| SECONDARY Clinic Appointment Attendance |
— | — |
| SECONDARY Home Medication Administration |
— | — |
Eligibility Criteria
Inclusion Criteria
- children ages 8 - 17 years and parent or primary caregiver 18 years or older
- child with sickle cell disease, as reported by clinician at MUSC Pediatric Sickle Cell Clinic
Exclusion Criteria
- Parent/caregiver or child with cognitive disability or delay that precludes ability to participate
- Lack of wi-fi access
Data sourced from ClinicalTrials.gov (NCT03585543). 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. Informational only — not medical advice.