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

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ClinicalTrials.gov Identifier: NCT02851615
Recruitment Status : Completed
First Posted : August 1, 2016
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: SCThrive Intervention for Adolescents with SCD Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SCThrive
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
Behavioral: SCThrive Intervention for Adolescents with SCD
Chronic Disease Self-Management Program

No Intervention: Attention Control
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.



Primary Outcome Measures :
  1. Change from baseline on behavioral activation measure at 6 weeks [ Time Frame: baseline, 6 weeks (post-intervention ]
    Participants complete a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851615


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Lori E Crosby, PsyD Children's Hospital Medical Center, Cincinnati

Publications of Results:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02851615     History of Changes
Other Study ID Numbers: 1R21HD084810-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Anemia, Sickle Cell
Self Care
Adolescent
Young Adult
Disease Management
Behavioral Activation
Peer Communication

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn