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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Management Group | Other | Self-management intervention for Adolescents with SCD - 6 week self-management group |
|
| Patient Portal | Other | Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-management intervention for Adolescents with SCD | Behavioral | Chronic Disease Self-Management Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori E Crosby, PsyD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25414800 | Background | 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. | |
| 10957829 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-Management Group | Self-management intervention for Adolescents with SCD - 6 week self-management group Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program |
| FG001 | Patient Portal | Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed baseline measures
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-Management Group | Self-management intervention for Adolescents with SCD - 6 week self-management group Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program |
| BG001 | Patient Portal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants with completed baseline and post measures. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks (post-intervention) |
|
During the 6 months participants were enrolled in the study.
An adverse event (AE) for the current study is an unfavorable medical occurrence in a participant temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. A serious adverse event (SAE) may or may not result in death, be life threatening, or require hospitalization. Since this population has frequent hospitalizations, only unexpected adverse events were reported here.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-Management Group | Self-management intervention for Adolescents with SCD - 6 week self-management group Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program |
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Pilot feasibility studies with convenience samples.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Crosby | CincinnatiChildrens | 5136365380 | lori.crosby@cchmc.org |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| Patient Portal Intervention for Adolescents with SCD | Behavioral | MyChart for SCD intervention |
|
| 25414599 | Result | 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. |
| 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. |
| Lost to Follow-up |
|
| potential COI - joined study team |
|
Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention
Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Patient Portal | Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention |
|
|
|
| 1 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Patient Portal | Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention | 0 | 44 | 0 | 44 | 0 | 44 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |