N/A N=30 Supportive Care

Self-Management for Youth and Families Living With SCD - SMYLS

Sickle Cell Disease

Bottom Line

View on ClinicalTrials.gov: NCT03585543 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Apr 2020

Primary outcome: Primary: Rates of Recruitment — 14 weeks

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Voice Crisis Alert V2 (Behavioral)
Age: Pediatric · 8+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Rates of Recruitment	14	—
PRIMARY Participant Adherence to Intervention	12; 2; 1	—
PRIMARY Acceptability of Intervention	4	—
PRIMARY Participant Adherence to Intervention	12; 2; 1	—
PRIMARY Participant Adherence to Intervention	12; 2; 1	—
PRIMARY Participant Adherence to Intervention	12; 2; 1	—
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	—	—

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)

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

View full record on ClinicalTrials.gov →

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.