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Trial record 6 of 184 for:    Recruiting, Not yet recruiting, Available Studies | "Anemia, Sickle Cell"

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

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ClinicalTrials.gov Identifier: NCT02475993
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Device: SMART app Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: SMART Mobile Application Technology Utilization in the Treatment of Sickle Cell Disease Post Day Hospital Discharge
Study Start Date : July 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: 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.

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



Primary Outcome Measures :
  1. percentage of acute care utilization [ Time Frame: 30 days following discharge from the day hospital ]

Secondary Outcome Measures :
  1. percentage adherence to hydroxyurea (HU) administration [ Time Frame: 30 days following discharge from the day hospital ]
  2. percentage adherence to post-acute care out-patient follow up visit [ Time Frame: 30 days following discharge from the day hospital ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02475993


Contacts
Contact: Nirmish Shah, MD 919-684-8111 nirmish.shah@dm.duke.edu
Contact: Betty Thames, BSN 919-681-9564 elizabeth.thames@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Nirmish Shah, MD    919-684-8111    nirmish.shah@dm.duke.edu   
Contact: Betty Thames, BSN    919-681-9564    elizabeth.thames@dm.duke.edu   
Sponsors and Collaborators
Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02475993     History of Changes
Other Study ID Numbers: Pro00062922
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Keywords provided by Duke University:
Sickle Cell Disease

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn