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

NCT02322307 | Completed

• 2 other identifiers: GCO 12-119512-0303(1001)
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Keywords

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Colitis; PRO; Patient-centric; HealthPROMISE

Outcome Measures

Primary Outcomes (1)

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

  Quality metrics for primary end-point will be adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations.

  up to 2 years

Secondary Outcomes (4)

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  up to 2 years

• Emergency visits and hospitalizations

  up to 2 years

• Change in generic QOL score (EQ5D)

  at year 1 and at year 2

• Predictors of HealthPromise app utilization (Utilization will be measured through individual logins and data entry in HealthPROMISE app)

  up to 2 years

Study Arms (2)

HealthPROMISE users

EXPERIMENTAL

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.

Other: HealthPROMISE users

Control Group

PLACEBO COMPARATOR

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.

Other: Control Group

Interventions

HealthPROMISE users OTHER

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.

Also known as: HealthPROMISE

HealthPROMISE users

Control Group OTHER

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.

Also known as: InformHealth

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years,
• Internet or Smartphone access
• Ability to complete a Tablet or web-based questionnaire in English language.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Atreja A, Khan S, Rogers JD, Otobo E, Patel NP, Ullman T, Colombel JF, Moore S, Sands BE; HealthPROMISE Consortium Group. Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2015 Feb 18;4(1):e23. doi: 10.2196/resprot.4042.

  PMID: 25693610 BACKGROUND

Related Links

• Health Promise: Empowering the Doctor and Patient Relationship

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Colitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ashish Atreja, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 23, 2014
• Study Start: February 1, 2015
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

US (1)