Inflammatory Bowel DiseaseNCT02322307
Trial on Impact of HealthPROMISE Mobile App on Inflammatory Bowel Disease Care and Quality of Life
A study testing HealthPROMISE users in people with Inflammatory Bowel Disease and Crohn's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- HealthPROMISE users
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 20 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years,
- Internet or Smartphone access
- Ability to complete a Tablet or web-based questionnaire in English language.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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
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.
Read the 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".
- Being tested
- HealthPROMISE users, Control Group
- Keywords
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Colitis, PRO, Patient-centric, HealthPROMISE
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthPROMISE usersOther
Also called HealthPROMISE
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.
Control GroupOther
Also called InformHealth
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years
Secondary outcomes (4)
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
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).
Measured: up to 2 years
Emergency visits and hospitalizations
Number of IBD related emergency visits and hospitalizations
Measured: up to 2 years
Change in generic QOL score (EQ5D)
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).
Measured: 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)
Utilization will be measured through individual logins and data entry in HealthPROMISE app.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashish Atreja, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322307
- Sponsor's protocol ID
- GCO 12-1195
- Other IDs
- 12-0303(1001)
- Status last verified
- May 2020
- First submitted
- 17 Dec 2014
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25693610
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02322307
- Acronym / sponsor ID
- GCO 12-1195
- Keywords
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Colitis, PRO, Patient-centric, HealthPROMISE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HealthPROMISE users | Experimental | Other: HealthPROMISE usersThese 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 | Placebo comparator | Other: Control GroupAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years,
- Internet or Smartphone access
- Ability to complete a Tablet or web-based questionnaire in English language.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthPROMISE usersAlso: HealthPROMISEPatients 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 | HealthPROMISE users |
| Control GroupAlso: InformHealthIn 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 | Control Group |
Primary outcome
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.
4 secondary outcomes
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: up to 2 years
Emergency visits and hospitalizations
Time frame: up to 2 years
Change in generic QOL score (EQ5D)
Time frame: 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)
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Background: PubMed 25693610Atreja 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.
- Health Promise: Empowering the Doctor and Patient RelationshipLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashish Atreja, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthPROMISE users in people with Inflammatory Bowel Disease and Crohn's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.