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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Publications of Results:

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.

Other 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.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT02200510
• Other Study ID Numbers: 5K07HL108720 ( U.S. NIH Grant/Contract )
• First Posted: July 25, 2014
• 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