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History of Changes for Study: NCT02322307
Trial on Impact of HealthPROMISE Mobile App on Inflammatory Bowel Disease Care and Quality of Life
Latest version (submitted May 6, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 22, 2014 None (earliest Version on record)
2 December 23, 2015 Recruitment Status, Study Status, References, Contacts/Locations and Oversight
3 June 30, 2016 Study Status
4 January 17, 2017 Study Status
5 June 27, 2017 Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
6 June 11, 2018 Study Status
7 February 7, 2019 Study Status
8 April 12, 2019 Study Status
9 June 12, 2019 Study Status
10 May 6, 2020 Recruitment Status and Study Status
Comparison Format:

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Study NCT02322307
Submitted Date:  December 22, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: GCO 12-1195
Brief Title: Trial on Impact of HealthPROMISE Mobile App on Inflammatory Bowel Disease Care and Quality of Life
Official Title: 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
Secondary IDs: 12-0303(1001) [GCO]
Open or close this module Study Status
Record Verification: December 2014
Overall Status: Not yet recruiting
Study Start: January 2015
Primary Completion: June 2017 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: December 17, 2014
First Submitted that
Met QC Criteria:
December 22, 2014
First Posted: December 23, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 22, 2014
Last Update Posted: December 23, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Icahn School of Medicine at Mount Sinai
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:

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".

Open or close this module Conditions
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Colitis
PRO
Patient-centric
HealthPROMISE
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: HealthPROMISE users
These are patients who will receive HealthPROMISE application. Patients will be asked to track their quality of life and quality of care using standardized metrics. A combination of different questionnaires (i.e. Short IBD Questionnaire), symptom updates, and IBD quality indicators will be the collected during this study through the HealthPROMISE application.
HealthPROMISE users

Patients using HealthPROMISE will be asked to use the application once every two weeks at a minimum to provide updates on health information. Providers can use the data entered by patients in real time. Patients will get alerts requesting them to contact their providers if their quality of life scores fall below a certain threshold or their symptoms scores are worrisome. Both patients and physicians are also sent regular notifications with data about their own health or health of their patient panel respectively. Both patients and providers are encouraged to use existing communication tools (phone, office visits, personal health records) since direct patient-physician messaging is not provided in the HealthPROMISE platform. Reminders through app, email and SMS will be used to facilitate patient engagement.

Physicians will also be encouraged to check the physician panel to see how patients are doing through weekly updates and monthly quality improvement meetings.

Other Names:
  • HealthPROMISE
Placebo Comparator: Control Group
After entering baseline questionnaire, control patients get a link to download education application along with PIN. Once patients install app on their devices and use the PIN, the patient is considered to be enrolled in the trial from intention to treat perspective. This control app allows access to patient education content only. There is not any direct feedback on Quality of Life, quality of care and resource utilization.
Control Group
In order to eliminate a placebo effect, patients in both groups will get an app customized for IBD. Physician and rest of care team will not be blinded since they will use HealthPROMISE dashboard to get alerts and notifications.
Other Names:
  • InformHealth
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations)
[ Time Frame: up to 2 years ]

Quality metrics for primary end-point will be adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations.
Secondary Outcome Measures:
1. Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
[ Time Frame: up to 2 years ]

The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (score 10-70, poor to good HRQoL).
2. Emergency visits and hospitalizations
[ Time Frame: up to 2 years ]

Number of IBD related emergency visits and hospitalizations
3. Change in generic QOL score (EQ5D)
[ Time Frame: at year 1 and at year 2 ]

The EuroQol (EQ)-5D questionnaire is a simple, generic instrument used to measure health-related quality of life (HRQOL). In a health profile, respondents describe their current health state in 5 dimensions (EQ-5D descriptive system): mobility, self-care, usual-activities (UA), pain/discomfort (P/D), and anxiety/depression (A/D). Problems in these dimensions are classified as none (score = 1), moderate (score = 2), or extreme (score = 3).
4. Predictors of HealthPromise app utilization (Utilization will be measured through individual logins and data entry in HealthPROMISE app)
[ Time Frame: up to 2 years ]

Utilization will be measured through individual logins and data entry in HealthPROMISE app.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Ashish Atreja, MD, MPH
Telephone: 212-241-4299
Email: ashish.atreja@mssm.edu
Central Contact Backup: Emamuzo Otobo, MD
Telephone: 212-241-4299
Email: emamuzo.otobo@mssm.edu
Study Officials: Ashish Atreja, MD, MPH
Principal Investigator
Icahn School of Medicine at Mount Sinai
Locations: United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Contact:Contact: Annabella Castillo, RN, MPH 212-241-2230 anabella.castillo@mssm.edu
Contact:Principal Investigator: Ashish Atreja, MD, MPH
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Health Promise: Empowering the Doctor and Patient Relationship
Available IPD/Information:

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