Clinical trial NCT02851615: Improving Self-Management in Adolescents With Sickle Cell Disease
Official title: SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Anemia, Sickle Cell
Self Care
Adolescent
Young Adult
Disease Management
Behavioral Activation
Peer Communication
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 66
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment)
timeFrame: baseline, 6 weeks (post-treatment)
Secondary outcomes:
measure: Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment)
timeFrame: baseline, 6 weeks (post-treatment)
measure: Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment
timeFrame: baseline, 6 weeks (post-treatment)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lori E Crosby, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crosby LE, Modi AC, Lemanek KL, Guilfoyle SM, Kalinyak KA, Mitchell MJ. Perceived barriers to clinic appointments for adolescents with sickle cell disease. J Pediatr Hematol Oncol. 2009 Aug;31(8):571-6. doi: 10.1097/MPH.0b013e3181acd889.
citation: Crosby LE, Joffe NE, Reynolds N, Peugh JL, Manegold E, Pai AL. Psychometric Properties of the Psychosocial Assessment Tool-General in Adolescents and Young Adults With Sickle Cell Disease. J Pediatr Psychol. 2016 May;41(4):397-405. doi: 10.1093/jpepsy/jsv073. Epub 2015 Aug 13.
citation: Crosby LE, Joffe NE, Dunseath LA, Lee R. Design Joins the Battle Against Sickle-cell Disease. Des Manage Rev. 2013 Summer;24(2):48-53. doi: 10.1111/drev.10241. No abstract available.
citation: Crosby LE, Hood A, Kidwell K, Nwankwo C, Peugh J, Strong H, Quinn C, Britto MT. Improving self-management in adolescents with sickle cell disease. Pediatr Blood Cancer. 2020 Oct;67(10):e28492. doi: 10.1002/pbc.28492. Epub 2020 Jul 22.