Back to resultsPatient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease (iTransition)
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-management intervention for Adolescents with SCD
Patient Portal Intervention for Adolescents with SCD
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Anemia, Sickle Cell, Transition to Adult Care, Self Care, Personal Electronic Health Records, Adolescent, Young Adult, Disease Management, Physician-Patient Relations
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Self-Management Group
Patient Portal
Arm Description
Self-management intervention for Adolescents with SCD - 6 week self-management group
Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02200510
First Posted
July 21, 2014
Last Updated
May 16, 2018
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02200510
Brief Title
Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease
Acronym
iTransition
Official Title
Patient-Provider Interventions to Improve Transition to Adult Care in SCD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Management Group
Arm Type
Other
Arm Description
Self-management intervention for Adolescents with SCD - 6 week self-management group
Arm Title
Patient Portal
Arm Type
Other
Arm Description
Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention
Intervention Type
Behavioral
Intervention Name(s)
Self-management intervention for Adolescents with SCD
Intervention Description
Chronic Disease Self-Management Program
Intervention Type
Behavioral
Intervention Name(s)
Patient Portal Intervention for Adolescents with SCD
Intervention Description
MyChart for SCD intervention
Primary Outcome Measure Information:
Title
Change From Baseline on Disease Self-efficacy Measure at 6 Weeks
Description
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).
Time Frame
baseline, 6 weeks (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori E Crosby, PsyD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25414800
Citation
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.
Results Reference
background
PubMed Identifier
10957829
Citation
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.
Results Reference
background
PubMed Identifier
25414599
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Learn more about this trial
Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease
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