Clinical trial NCT03585543: Self-Management for Youth and Families Living With SCD - SMYLS
Official title: Self-Management for Youth and Families Living With Sickle Cell Disease - SMYLS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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

Primary outcomes:
measure: Rates of Recruitment
timeFrame: Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.
measure: Participant Adherence to Intervention
timeFrame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
measure: Acceptability of Intervention
timeFrame: Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.
measure: Participant Adherence to Intervention
timeFrame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
measure: Participant Adherence to Intervention
timeFrame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
measure: Participant Adherence to Intervention
timeFrame: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Secondary outcomes:
measure: Difference in Mean Pain Score Rating From Baseline to End-of-intervention
timeFrame: baseline, 12 weeks
measure: Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention
timeFrame: baseline, 12 weeks
measure: Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention
timeFrame: baseline, 12 weeks
measure: Difference in Mean Scores for Fatigue From Baseline to End-of-intervention
timeFrame: baseline, 12 weeks
measure: Difference in Mean Scores for Anxiety From Baseline to End-of-intervention
timeFrame: baseline, 12 weeks
measure: Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention
timeFrame: baseline,12 weeks
measure: Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention
timeFrame: baseline, 12 weeks
measure: Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention
timeFrame: baseline, 12 weeks
measure: Clinic Appointment Attendance
timeFrame: 12 weeks
measure: Home Medication Administration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: