Sickle Cell Disease
Conditions
Keywords
Anemia, Sickle Cell, Transition to Adult Care, Self Care, Personal Electronic Health Records, Adolescent, Young Adult, Disease Management, Physician-Patient Relations
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.
Interventions
BEHAVIORALSelf-management intervention for Adolescents with SCD
Chronic Disease Self-Management Program
BEHAVIORALPatient Portal Intervention for Adolescents with SCD
MyChart for SCD intervention
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 24 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Disease Self-efficacy Measure at 6 Weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 44 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 7 | 1 |
| Overall Study | potential COI - joined study team | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Self-Management Group | Patient Portal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 13 Participants | 26 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 18 Participants | 27 Participants |
| Age, Continuous | 18.77 years STANDARD_DEVIATION 2.22 | 18.82 years STANDARD_DEVIATION 2.72 | 18.795 years STANDARD_DEVIATION 2.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 44 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 22 Participants | 44 Participants | 66 Participants |
| Sex: Female, Male Female | 10 Participants | 24 Participants | 34 Participants |
| Sex: Female, Male Male | 12 Participants | 20 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 22 | 0 / 44 |
| other Total, other adverse events | 0 / 22 | 0 / 44 |
| serious Total, serious adverse events | 0 / 22 | 0 / 44 |
Outcome results
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).
Time frame: baseline, 6 weeks (post-intervention)
Population: Participants with completed baseline and post measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Management Group | Change From Baseline on Disease Self-efficacy Measure at 6 Weeks | 33.2 units on a scale | Standard Deviation 5.49 |
| Patient Portal | Change From Baseline on Disease Self-efficacy Measure at 6 Weeks | 33.09 units on a scale | Standard Deviation 7.1 |
p-value: 0.575ANOVA
p-value: 0.721ANOVA