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SMART Mobile Application Technology Utilization in the Treatment of Sickle Cell Disease Post Day Hospital Discharge

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475993
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE June 17, 2015
First Posted Date  ICMJE June 19, 2015
Last Update Posted Date October 18, 2019
Study Start Date  ICMJE July 2015
Actual Primary Completion Date September 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
percentage of acute care utilization [ Time Frame: 30 days following discharge from the day hospital ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
  • percentage adherence to hydroxyurea (HU) administration [ Time Frame: 30 days following discharge from the day hospital ]
  • percentage adherence to post-acute care out-patient follow up visit [ Time Frame: 30 days following discharge from the day hospital ]
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 SMART Mobile Application Technology Utilization in the Treatment of Sickle Cell Disease Post Day Hospital Discharge
Official Title  ICMJE SMART Mobile Application Technology Utilization in the Treatment of Sickle Cell Disease Post Day Hospital Discharge
Brief Summary The purpose of this study is to test a web-aided, mobile-based PHR (Personal Health Reporting) service to enhance SCD outpatient treatment after discharge from an acute care setting, such as Duke University Medical Center's Day Hospital. SMART is a new mobile application created by SickleSoft to increase patient involvement in their treatment and improve patient to doctor communication. SMART is a self-monitoring and management service for SCD patients and their treatment doctors. This study will test whether or not use of the SMART mobile application will help develop the type of patient-doctor relationships that lead to better health outcomes and a decrease in readmission to an acute care facility.
Detailed Description

All patients seen for acute care of painful episodes in our Adult Sickle Cell Day Hospital will be screened for eligibility. Currently, there are >450 patients actively followed by staff in our adult Comprehensive Sickle Cell Center, with an average of 60-70 patient day hospital visits per month.

Intervention and control group. Patients enrolled will be alternately assigned to each group to ensure randomization and equal numbers of patients to each arm. All patients will be given a return appointment within 12 days of Day Hospital visit. The control group will get standard of care, including a printed plan for medications to be taken, phone number to call for questions or issues, and the return date for visit.

SMART Overview. SMART, a mobile phone-based self-monitoring service to enhance outpatient treatment in chronic illness will be tested for its utility to help reduce acute care utilization rates for patients given SMART following acute care visits at the Sickle Cell Day Hospital. SMART will enable symptom monitoring with a particular emphasis on pain measures, co-symptoms, and related interventions aided by provider daily monitoring and support guided by patient report via SMART to provide a Sickle Cell Disease Information interchange (SCDi) service. Instead of using their current routine of triaging phone messages daily, assessing patients' need for intervention, providers will instead monitor patients' entries via SMART daily. Our current clinicians, a nurse practitioner or medical doctor, will review data generated from patients' reports, as well as patient phone calls. Data entered daily by patients will be viewable by our clinicians. Rather than only listening to voice mails, a clinician from our provider team will view an electronic record and communicate with patients electronically by push notification, text messaging, secure email, or via the app. Our clinicians may also call patients by telephone, as they would do as necessary when responding to voice mails. .

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Other: SMART app
Subjects assigned to the intervention group will be given the pre-programmed SMART app on an iPad mini loaned to you for use during the study along with the medication plan as outlined in the discharge instructions and an appointment within 12 days. This will include SCD-related medications. Subjects will be asked to log entries each time they take their medications and will be reminded by SMART to take their medications based on their advised schedule. Follow up appointment time and date are also programmed into SMART, and reminders are given to the subject 3 days prior and on the day of appointment. Compliance will also be confirmed by pill count of all medications at the 30-day visit.
Study Arms  ICMJE
  • Experimental: SMART app
    SMART, a mobile phone-based self-monitoring service to enhance outpatient treatment in chronic illness will be tested for its utility to help reduce acute care utilization rates for patients given SMART following acute care visits at the Sickle Cell Day Hospital. SMART will enable symptom monitoring with a particular emphasis on pain measures, co-symptoms, and related interventions aided by provider daily monitoring and support guided by patient report via SMART to provide a Sickle Cell Disease Information interchange (SCDi) service. Instead of using their current routine of triaging phone messages daily, assessing patients' need for intervention, providers will instead monitor patients' entries via SMART daily.
    Intervention: Other: SMART app
  • No Intervention: Standard of care control group
    The control group will get standard of care, including a printed plan for medications to be taken, phone number to call for questions or issues, and the return date for visit
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
Actual Enrollment  ICMJE
 (submitted: October 17, 2019)
45
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2015)
100
Actual Study Completion Date  ICMJE September 14, 2017
Actual Primary Completion Date September 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • documented Hgb SS, SC, or HgbS-beta0 thalassemia
  • age 18 years old or older
  • seen during an acute care visit at the Duke Day Hospital

Exclusion Criteria:

  • incapable of giving informed consent
  • greater than 20 acute care visits within the past year
  • patients on chronic RBC transfusions (scheduled transfusions)
  • patients admitted to the hospital from the day hospital
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02475993
Other Study ID Numbers  ICMJE Pro00062922
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date September 2019

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