Trial on Impact of HealthPROMISE Mobile App on Inflammatory Bowel Disease Care and Quality of Life
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colitis, Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | February 2015 |
| End Date: | March 31, 2019 |
A Pragmatic Randomized Controlled Trial to Evaluate the Impact of HealthPROMISE Platform on Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease
HealthPROMISE is a mobile application (app) for patients that allows regular tracking of
symptoms by patients and communicates them to physicians. The purpose of this randomized
controlled trial is to determine the impact of the HealthPROMISE application on improving
patient outcomes. The trial will look at how much patients use the application, whether
physicians change treatment in response to new information from patients, and how the
patients quality of life change over the span of the study. The investigators hypothesize
that HealthPROMISE will enhance physician-patient communication and improve clinical
outcomes.
symptoms by patients and communicates them to physicians. The purpose of this randomized
controlled trial is to determine the impact of the HealthPROMISE application on improving
patient outcomes. The trial will look at how much patients use the application, whether
physicians change treatment in response to new information from patients, and how the
patients quality of life change over the span of the study. The investigators hypothesize
that HealthPROMISE will enhance physician-patient communication and improve clinical
outcomes.
This study will prospectively enroll about 300 patients with Crohn's Disease or Ulcerative
Colitis presenting at the Mount Sinai Health System.
Eligible participants who complete the informed consent will fill a Tablet or Web-based
questionnaire at the end of which they will be given a pin and offered to download the
HealthPROMISE app or an education app. Patients who download HealthPROMISE app will then be
requested to provide updates on quality metrics, a quality of life questionnaire, and
emergency visits and hospitalizations.
Data will be collected continuously throughout the study using the mobile health app. Study
endpoints will primarily be assessed using "intention to treat" analysis. Additionally, per
protocol analysis of data will be performed for patients who have logged into the application
at least 4 times in 12 months. The total study duration will be 2 years (104 weeks). At 1
year (52 weeks), an interim analysis will be done to determine if study needs to be continued
for full 104 weeks. Furthermore, patients in either arm who login using PIN but not
completing week 52 (or week 104) exit survey will be considered as "lost to follow up".
Colitis presenting at the Mount Sinai Health System.
Eligible participants who complete the informed consent will fill a Tablet or Web-based
questionnaire at the end of which they will be given a pin and offered to download the
HealthPROMISE app or an education app. Patients who download HealthPROMISE app will then be
requested to provide updates on quality metrics, a quality of life questionnaire, and
emergency visits and hospitalizations.
Data will be collected continuously throughout the study using the mobile health app. Study
endpoints will primarily be assessed using "intention to treat" analysis. Additionally, per
protocol analysis of data will be performed for patients who have logged into the application
at least 4 times in 12 months. The total study duration will be 2 years (104 weeks). At 1
year (52 weeks), an interim analysis will be done to determine if study needs to be continued
for full 104 weeks. Furthermore, patients in either arm who login using PIN but not
completing week 52 (or week 104) exit survey will be considered as "lost to follow up".
Inclusion Criteria:
- Age >18 years,
- Internet or Smartphone access
- Ability to complete a Tablet or web-based questionnaire in English language.
Exclusion Criteria:
- Presence of short bowel syndrome, stoma or pouch.
- Presence of a condition or disease that, in the opinion of the investigators, may make
it exceedingly difficult for the patient to use HealthPROMISE App, including, but not
limited to, advanced dementia.
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Ashish Atreja, MD, MPH
Phone: 212-241-2230
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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