Trial on Impact of HealthPROMISE Mobile App on Inflammatory Bowel Disease Care and Quality of Life

Not Applicable

Completed

• Conditions: Crohn's Disease; Inflammatory Bowel Disease; Ulcerative Colitis
• Interventions: Other: HealthPROMISE users; Other: Control Group

• Registration Number: NCT02322307
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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".

Study Timeline

• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Study Start: 2015-02
• Primary Completion: 2020-01-20
• Study Completion: 2020-01-20
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HealthPROMISE users	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.
Control Group	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.

Primary Outcome Measures

Name	Time	Method
Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations)	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

Name	Time	Method
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	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).
Emergency visits and hospitalizations	up to 2 years	Number of IBD related emergency visits and hospitalizations
Predictors of HealthPromise app utilization (Utilization will be measured through individual logins and data entry in HealthPROMISE app)	up to 2 years	Utilization will be measured through individual logins and data entry in HealthPROMISE app.
Change in generic QOL score (EQ5D)	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).

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States