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

NCT02200510 | Completed Results

• 1 other identifier: 5K07HL108720
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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).

Conditions

Sickle Cell Disease

Keywords

Anemia, Sickle Cell; Transition to Adult Care; Self Care; Personal Electronic Health Records; Adolescent; Young Adult; Disease Management; Physician-Patient Relations

Outcome Measures

Primary Outcomes (1)

• Change From Baseline on Disease Self-efficacy Measure at 6 Weeks

  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).

  baseline, 6 weeks (post-intervention)

Study Arms (2)

Self-Management Group

OTHER

Self-management intervention for Adolescents with SCD - 6 week self-management group

Behavioral: Self-management intervention for Adolescents with SCD

Patient Portal

OTHER

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

Behavioral: Patient Portal Intervention for Adolescents with SCD

Interventions

Self-management intervention for Adolescents with SCD BEHAVIORAL

Chronic Disease Self-Management Program

Self-Management Group

Patient Portal Intervention for Adolescents with SCD BEHAVIORAL

MyChart for SCD intervention

Patient Portal

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (5)

• 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.

  PMID: 25414800 BACKGROUND

• 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.

  PMID: 10957829 BACKGROUND

• 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.

  PMID: 25414599 RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Pilot feasibility studies with convenience samples.

Results Point of Contact

• Title: Lori Crosby
• Organization: CincinnatiChildrens

lori.crosby@cchmc.org

5136365380

Study Officials

• Lori E Crosby, PsyD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 25, 2014
• Study Start: June 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 15, 2018
• Results First Posted: June 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)