N/A
Completed N=80
SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
Source: ClinicalTrials.gov NCT04289311 ↗Enrolled (actual)
80
Serious AEs
6.3%
Results posted
Aug 2024
Primary outcomePrimary: Rate of Recruitment: Dyads — 2 dyads recruited and enrolled/week
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Recruitment: Dyads |
2 | — |
| PRIMARY Participant Adherence to the Intervention |
24; 12 | — |
| PRIMARY Consistency of Intervention Delivery |
30; 15 | — |
| PRIMARY Projection of Future Adoption |
12; 9 | — |
| PRIMARY Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks |
16; 8 | — |
| PRIMARY Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks |
12; 4 | — |
| PRIMARY Rate of Recruitment: Young Adults |
4 | — |
| SECONDARY Difference in Mean Pain Score Rating From Baseline to End-of-Intervention |
-8.5; -6.8 | — |
| SECONDARY Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention |
0.6; 1.2 | — |
| SECONDARY Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention |
-1.5; 2.3; -0.2 | — |
| SECONDARY Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-Intervention |
-1.4; -2.2; 0.8 | — |
| SECONDARY Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention |
-2.7; -3.8 | — |
| SECONDARY Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention |
-0.7; -5.2; 2.3 | — |
| SECONDARY Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention |
0.9; -3.4 | — |
| SECONDARY Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention |
7.2; 2.2; 7.4; 2.7; 3.1; 6.1 | — |
| SECONDARY Difference in Mean Scores for Self-Efficacy From Baseline to End-of-Intervention |
-0.6; 0.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT04289311). 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.