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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02322307
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Other: HealthPROMISE users Other: Control Group Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Study Start Date : February 2015
Actual Primary Completion Date : January 20, 2020
Actual Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: 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 Name: 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.
Other: 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 Name: InformHealth




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322307


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Ashish Atreja, MD, MPH Icahn School of Medicine at Mount Sinai
Additional Information:
Publications:
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02322307    
Other Study ID Numbers: GCO 12-1195
12-0303(1001) ( Other Identifier: GCO )
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icahn School of Medicine at Mount Sinai:
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Colitis
PRO
Patient-centric
HealthPROMISE
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes