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Improving Self-Management in Adolescents With Sickle Cell Disease (SCThrive)

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Sickle Cell Disease

Treatments

Behavioral: SCThrive Intervention for Adolescents with SCD

Study type

Interventional

Funder types

Other

Identifiers

NCT02851615
1R21HD084810-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

13 to 21 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

SCThrive
Other group
Description:
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
Treatment:
Behavioral: SCThrive Intervention for Adolescents with SCD
Attention Control
No Intervention group
Description:
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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