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

• 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: Children's Hospital Medical Center, Cincinnati
• Information provided by (Responsible Party): Children's Hospital Medical Center, Cincinnati

Tracking Information

• First Submitted Date: July 21, 2014
• First Posted Date: July 25, 2014
• Results First Submitted Date: February 9, 2018
• Results First Posted Date: June 15, 2018
• Last Update Posted Date: June 15, 2018
• Study Start Date: June 2011
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 16, 2018)

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).

Original Primary Outcome Measures (submitted: July 23, 2014)

Change from baseline on disease self-efficacy measure at 6 weeks [ Time Frame: baseline, 6 weeks (post-intervention) ]

Participants complete an 8 item measure of sickle cell disease self-efficacy developed by Telfair et al, 2007.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease
• Official Title: Patient-Provider Interventions to Improve Transition to Adult Care in SCD
• 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).
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sickle Cell Disease

Intervention

• Behavioral: Self-management intervention for Adolescents with SCD
  Chronic Disease Self-Management Program
• Behavioral: Patient Portal Intervention for Adolescents with SCD
  MyChart for SCD intervention

Study Arms

• Self-Management Group
  Self-management intervention for Adolescents with SCD - 6 week self-management group
  Intervention: Behavioral: Self-management intervention for Adolescents with SCD
• Patient Portal
  Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention
  Intervention: Behavioral: Patient Portal Intervention for Adolescents with SCD

Publications *

• Crosby LE, Smith T, Parr WD, Mitchell MJ. The Community Engagement and Translational Research Speaker Series: An Innovative Model of Health Education. J Community Med Health Educ. 2013 Jul 24;3:1000227. doi: 10.4172/2161-0711.1000227.
• Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000 Sep;38(9):951-63. doi: 10.1016/s0005-7967(99)00140-0.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 16, 2018): 78
• Original Estimated Enrollment (submitted: July 23, 2014): 85
• Actual Study Completion Date: August 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 24 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02200510
• Other Study ID Numbers: 5K07HL108720( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Children's Hospital Medical Center, Cincinnati
• Original Responsible Party: Same as current
• Current Study Sponsor: Children's Hospital Medical Center, Cincinnati
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lori E Crosby, PsyD; Children's Hospital Medical Center, Cincinnati

• PRS Account: Children's Hospital Medical Center, Cincinnati
• Verification Date: May 2018