SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain
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|ClinicalTrials.gov Identifier: NCT03006718|
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : February 24, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Sickle Cell Hematologic Diseases||Other: PROMIS for Pain Management App||Not Applicable|
|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|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2019|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||8 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006718
|United States, District of Columbia|
|Children's National Hospital|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Julia Finkel, MD||Children's National Research Institute|
|Responsible Party:||Julia Finkel, ANESTHESIOLOGIST, Children's National Research Institute|
|Other Study ID Numbers:||
|First Posted:||December 30, 2016 Key Record Dates|
|Last Update Posted:||February 24, 2021|
|Last Verified:||February 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn