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Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease (iTransition)

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ClinicalTrials.gov Identifier: NCT02200510
Recruitment Status : Completed
First Posted : July 25, 2014
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
The purpose of the study is to develop patient-provider clinical support tools to improve clinical practice, patient self-management, and disease outcomes in sickle cell disease during transition to adult care. The investigators hypothesize that these clinical support tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible, user friendly, and beneficial. The investigators hypothesize that participants will demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain these gains during the follow-up period (up to 1 year post-intervention).

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Self-management intervention for Adolescents with SCD Behavioral: Patient Portal Intervention for Adolescents with SCD Not Applicable

Detailed Description:
The purpose of the study is to develop patient-provider clinical support tools to improve clinical practice, patient self-management, and disease outcomes in sickle cell disease during transition to adult care.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient-Provider Interventions to Improve Transition to Adult Care in SCD
Study Start Date : June 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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

Patient Portal
Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention
Behavioral: Patient Portal Intervention for Adolescents with SCD
MyChart for SCD intervention




Primary Outcome Measures :
  1. Change From Baseline on Disease Self-efficacy Measure at 6 Weeks [ Time Frame: baseline, 6 weeks (post-intervention) ]

    Name of Measure: Sickle Cell Self-Efficacy Scale (SCSES). Construct: sickle cell self-efficacy (disease specific self-efficacy) 9 item measure of sickle cell disease self-efficacy (likert scale from 1 [not at all sure] to 5 [very sure]) developed by Edwards (see References).

    Responses on items are summed to compute a total score. Minimum score: 9 Maximum score: 45 Higher scores represent higher sickle cell self-efficacy (better outcome).




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Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have sickle cell disease (SCD)
  • Between the ages of 13 and 24
  • Receive care at Cincinnati Children's Hospital Medical Center, University Hospital, University of Cincinnati Med Peds Practice, a practice in the Ohio Valley SCD Network, or another local provider
  • Parent/caregiver of a patient with SCD age 13-24 years

Exclusion Criteria:

  • Below age 13
  • Have significant health complication(s) that would interfere with completion of the intervention (by physician report)
  • Have significant cognitive or developmental disabilities (by parent or physician report) due to high demand on participants to understand questions
  • Are not a patient at Cincinnati Children's Hospital Medical Center, University Hospital, University of Cincinnati Med Peds Practice, a practice in the Ohio Valley SCD Network, or another local provider
  • Are not a parent/caregiver of a patient with SCD age 13-24 years

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): NCT02200510


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:
Crosby, L.E., Hudepohl, M., Kalinyak, K., Britto, M., Goldstein, A., Brown, K., Culp, A., & Joiner, C. H. (2013). Impact of use of a disease-specific patient portal on transition readiness and quality of life in adolescents with sickle cell disease [Abstract]. Blood, 122(21), 2982.
Crosby, L. E., Joffe, N., Kalinyak, K., Bruck, A. & Joiner, C. H. (2013). Six-month data from a pilot self-management intervention for adolescents with sickle cell disease [Abstract]. Blood, 122(21), 1675.

Other Publications:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02200510     History of Changes
Other Study ID Numbers: 5K07HL108720 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2014    Key Record Dates
Results First Posted: June 15, 2018
Last Update Posted: June 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Anemia, Sickle Cell
Transition to Adult Care
Self Care
Personal Electronic Health Records
Adolescent
Young Adult
Disease Management
Physician-Patient Relations

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