N/A
Completed N=58
Improving Self-Management in Adolescents With Sickle Cell Disease
Source: ClinicalTrials.gov NCT02851615 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) — 68.48; 69.13; 76.57; 68.82 score on a scale — p=.09
Summary
The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that participants in the SCThrive group will show greater BA (primary outcome) at post-treatment than the attention control group, and that participants in the SCThrive group will continue to show significantly greater BA at the six week follow-up compared to the attention control group. Investigators will also explore whether SCThrive is associated with greater improvements in self-management behaviors and quality of life (secondary outcome) compared to attention control at the six-week follow-up assessment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) |
68.48; 69.13; 76.57; 68.82 | .09 |
| SECONDARY Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) |
3.46; 3.54; 3.68; 3.53 | .28 |
| SECONDARY Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment |
1.19; 1.15 | .27 |
Eligibility Criteria
Inclusion Criteria
- Patient of CCHMC Sickle Cell Clinic.
- Confirmed diagnosis of SCD with SS, SB0Thal or SC genotype.
- 13-21 years of age.
- On or eligible for disease-modifying therapies.
- Caregiver (or AYA > 18 years) consent that the participant will be the sole user of the tablet, report immediately if it is damaged or lost, return it at the end of the study, and log on to sessions from a private location.
Exclusion Criteria
- another chronic disease (which would complicate measurement of behavioral activation)
- Non-English-speaking (<5% of the target population); or
- cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation. Patients who desire participation but are not eligible will be referred to the SCD Clinic social worker for assistance with self-management as this is the usual procedure.
Data sourced from ClinicalTrials.gov (NCT02851615). 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.