Sickle Cell DiseaseNCT02475993
SMART Mobile Application Technology Utilization in the Treatment of Sickle Cell Disease Post Day Hospital Discharge
A study testing SMART app in people with Sickle Cell Disease, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- SMART app
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 14 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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. .
- Conditions
- Sickle Cell Disease
- Being tested
- SMART app
- Keywords
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART appOther
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 group | Role | What they receive |
|---|---|---|
| SMART app | Experimental | 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. Receives: Other: SMART app |
| Standard of care control group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of acute care utilization
Measured: 30 days following discharge from the day hospital
Secondary outcomes (2)
percentage adherence to hydroxyurea (HU) administration
Measured: 30 days following discharge from the day hospital
percentage adherence to post-acute care out-patient follow up visit
Measured: 30 days following discharge from the day hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475993
- Sponsor's protocol ID
- Pro00062922
- Status last verified
- Sep 2019
- First submitted
- 17 Jun 2015
- Last updated
- 18 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Mobile Application Technology Utilization in the Treatment of Sickle Cell Disease Post Day Hospital Discharge
- ClinicalTrials.gov ID
- NCT02475993
- Acronym / sponsor ID
- Pro00062922
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART app | Experimental | Other: SMART appSMART, 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. |
| Standard of care control group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART appSubjects 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. | Other | SMART app |
Primary outcome
percentage of acute care utilization
Time frame: 30 days following discharge from the day hospital
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART app in people with Sickle Cell Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of acute care utilization (time frame: 30 days following discharge from the day hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.