SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03006718|
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment|
|Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Sickle Cell Hematologic Diseases||Other: PROMIS for Pain Management App|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
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).
Other: PROMIS for Pain Management App
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 Name: SCD-PROMIS
- 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.
- 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).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006718
|Contact: Zenaide Quezado, MDemail@example.com|
|Contact: Elizabeth Walekfirstname.lastname@example.org|
|United States, District of Columbia|
|Children's National Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Zenaide Quezado, MD 202-476-2025 email@example.com|
|Principal Investigator: Zenaide Quezado, MD|
|Sub-Investigator: Elizabeth Walek|
|Principal Investigator:||Zenaide Quezado, MD||Children's Research Institute|