Clinical trial NCT04289311: SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
Official title: SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to find out whether a web-based intervention using a mobile device is helpful for teens learning to care for and manage symptoms of sickle cell disease. The intervention lasts 12 weeks with a 3-month follow up period, and uses a smartphone or a tablet.

Detailed description: The purpose of the proposed study is to test the feasibility of SMYLS, an mHealth intervention designed to facilitate self-management behaviors in children and adolescents with sickle cell disease (SCD). Specifically, the investigators propose to test the feasibility of the intervention for improving transition from parent-managed to adolescent self-managed care. In addition, the investigators will evaluate the communication that takes place via the intervention between adolescents, their parents/caregivers, and healthcare providers. The investigators will work with the MUSC Pediatric Sickle Cell Clinic to identify and recruit 5 healthcare providers of children with SCD and 30 dyads of adolescents ages 11 - 17 SCD and their parent/caregiver (n = 60).

Eligibility criteria: Inclusion Criteria:

* diagnosis of SCD as reported by provider
* self-reported history of pain at least once per month
* caregiver/parent willingness to participate
* owns a smartphone

Exclusion Criteria:

* not under the care of a provider participant
* cognitive disability or delay that precludes ability to participate, defined as classified severe neurocognitive deficits as documented by neuropsychological evaluation in the medical record
* lack of wi-fi access

Primary outcomes:
measure: Rate of Recruitment: Dyads
timeFrame: 6 months
measure: Participant Adherence to the Intervention
timeFrame: baseline to 6 weeks
measure: Consistency of Intervention Delivery
timeFrame: 24 weeks
measure: Projection of Future Adoption
timeFrame: 12 weeks
measure: Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks
timeFrame: 6 weeks to 12 weeks
measure: Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks
timeFrame: 12 weeks to 24 weeks
measure: Rate of Recruitment: Young Adults
timeFrame: 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 Scores for Transition Readiness 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-interention
timeFrame: baseline, 12 weeks
measure: Difference in Mean Scores for Fatigue 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: Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention
timeFrame: baseline, 12 weeks
measure: Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: