- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006718
SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants with Sickle Cell Disease (SCD) (HbSS, HbSC, HbSβ0 thalassemia, HbSβ+ thalassemia, HbSOArab) admitted to the hospital for vaso-occlusive crisis (VOE)-related pain within the age range of 8 - 21 years.
- Ability to provide informed consent/assent, comply with study related procedures, evaluations, and follow-up. In the event that a patient does not have a smart mobile device (i.e., one that can support the study application), one will be provided for the patient. Patients younger than the age of 11 years may use their parents phone if they do not have one. If a patient has a smart mobile device but their parent does not want them to use the device for the study, the patient may use their parent's phone instead.
- Parent of participants with SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSβ+ thalassemia HbSOArab) admitted to the hospital for vaso-occlusive crisis (VOE)-related pain within the age range of 8 - 17 years who has assented to participate in the study.
- Ability to provide informed consent, comply with study related procedures, evaluations, and follow-up. In the event that a parent does not have a mobile device, one will be provided for the duration of the study.
Exclusion Criteria:
- Inability to give informed consent/assent as determined by the investigators
- Patients with SCD who were admitted for reasons other than VOE-related pain
- Parents of patients with SCD who were admitted for reasons other than VOE-related pain or do not assent to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Patients
Participants must have SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSβ+ thalassemia, HbSOArab), within the age range of 8 - 21 years, and be admitted to the hospital for vaso-occlusive crisis (VOE)-related pain. The investigators will also collect Proxy PROMIS measures from parents of participants between the ages of 8 and 17-years who have agreed to participate in the study. All participants will use the PROMIS for Pain Management App over 5 consecutive weeks (starting at hospital discharge). |
At hospital discharge, the investigators will collect baseline surveys, a blood sample, and download the PROMIS for Pain Management App onto the subject's mobile device.
For five consecutive weeks, PROMIS measures will be collected through weekly surveys.
The investigators plan to compensate patients for their time.
Patients will come back to the hospital after 35 days for a final blood draw and set of surveys.
In the event a patient gets readmitted, the investigators will record that admission.
The investigators will also collect Proxy PROMIS measures from parents of participants between the ages of 8 and 17-years who have agreed to participate in the study.
It is the goal of the investigators to engage one of the parents in the reporting of weekly validated Proxy PROMIS measures.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission rate
Time Frame: 35 days
|
The investigators want to determine if the use of this mobile app by itself reduces readmission rates.
The investigators will compare the readmission rate of patients who use this mobile app with those who do not.
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35 days
|
Readmission risk
Time Frame: 35 days
|
The rate of hospital readmission will be estimated by time periods (e.g., 1, 2, 3, and 4 weeks after discharge).
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35 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Compliance
Time Frame: 35 days
|
To evaluate our app design features, the investigators will track each user's interaction with the app for post-analysis to determine time spent answering the questions and the value of reminders.
It is the investigators intent to determine if features will be used as intended by the app design.
|
35 days
|
Patient Usability
Time Frame: 35 days
|
At the end of five weeks the investigators will administer a survey to parents and participants to determine the usability of this app.This information will lead to improvements on the design of future iterations of the app.
|
35 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia Finkel, MD, Children's National Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7618
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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