NCT02475993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2017

Completed
Last Updated

October 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

June 17, 2015

Last Update Submit

October 17, 2019

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • percentage of acute care utilization

    30 days following discharge from the day hospital

Secondary Outcomes (2)

  • percentage adherence to hydroxyurea (HU) administration

    30 days following discharge from the day hospital

  • percentage adherence to post-acute care out-patient follow up visit

    30 days following discharge from the day hospital

Study Arms (2)

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.

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

Interventions

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.

SMART app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 19, 2015

Study Start

July 1, 2015

Primary Completion

September 14, 2017

Study Completion

September 14, 2017

Last Updated

October 18, 2019

Record last verified: 2019-09

Locations

US(1)