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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
Sponsor:
Collaborators:
Arizona State University
Children's National Research Institute
Information provided by (Responsible Party):
Julia Finkel, Children's National Research Institute

Tracking Information
First Submitted Date  ICMJE December 22, 2016
First Posted Date  ICMJE December 30, 2016
Last Update Posted Date February 24, 2021
Study Start Date  ICMJE November 2016
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain
Official Title  ICMJE SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain
Brief Summary The overall goal of the project is to reduce pain-related, 30-day readmission rates for sickle cell disease (SCD) patients. The investigators want to see if a mobile phone application (app) can help decrease the need for repeat admission to the hospital because of sickle cell pain.
Detailed Description Pain is the main reason why SCD patients are admitted and readmitted to the hospital. In fact, readmission rates of SCD patients are higher than those of asthmatics and diabetics. In order to reduce 30-day hospital readmission rates and improve patient care quality, the Affordable Care Act and Centers for Medicare and Medicaid Services have established the Readmissions Reduction Program. In keeping with this effort, the investigators propose a methodology and supporting technology that has the potential to change the way SCD patients are monitored after hospital discharge and in turn, decrease readmission rates. This methodology also has the potential to enhance the quality of life of SCD patients by improving patient reporting, self-efficacy, and increasing patient/provider engagement when there is worsening pain and increased admission/readmission risk. This software platform uses validated Patient Reported Outcome Measurement Information System (PROMIS) measures to remotely monitor SCD patients' pain and related outcomes after hospital discharge. With this initial study, the investigators propose to use this monitoring platform to identify the predictors of readmission, to develop a readmission prediction engine, and to design the next version of the app with built in interventions to address those readmission risks. This monitoring platform could also increase healthcare provider engagement when there is a worsening of patients' pain and/or an increased risk of readmission. In order to build and optimize this monitoring platform, the investigators have assembled a team of engineers, hematologists, pain researchers, and statisticians that have worked together, and who collectively have the expertise to develop and test the feasibility and predictive value of the application in a large population of SCD patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Sickle Cell Disease
  • Anemia
  • Anemia, Hemolytic
  • Anemia, Sickle Cell
  • Hematologic Diseases
Intervention  ICMJE 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
Study Arms  ICMJE 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).

Intervention: Other: PROMIS for Pain Management App
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 28, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2019
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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:

  1. Inability to give informed consent/assent as determined by the investigators
  2. Patients with SCD who were admitted for reasons other than VOE-related pain
  3. Parents of patients with SCD who were admitted for reasons other than VOE-related pain or do not assent to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03006718
Other Study ID Numbers  ICMJE 7618
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Julia Finkel, Children's National Research Institute
Study Sponsor  ICMJE Julia Finkel
Collaborators  ICMJE
  • Arizona State University
  • Children's National Research Institute
Investigators  ICMJE
Principal Investigator: Julia Finkel, MD Children's National Research Institute
PRS Account Children's National Research Institute
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP