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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sickle Cell Disease | Other: SMART app | Not Applicable |
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) |
Actual Enrollment : | 45 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 |
Actual Primary Completion Date : | September 14, 2017 |
Actual Study Completion Date : | September 14, 2017 |

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.
|
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. |
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
|
- percentage of acute care utilization [ Time Frame: 30 days following discharge from the day hospital ]
- 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 ]

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

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
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT02475993 |
Other Study ID Numbers: |
Pro00062922 |
First Posted: | June 19, 2015 Key Record Dates |
Last Update Posted: | October 18, 2019 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sickle Cell Disease |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |