Inflammatory Bowel DiseasesMyIBDNCT03241992
MyChart in Patients With Inflammatory Bowel Disease.
A study testing MyChart Disease Specific in people with Inflammatory Bowel Diseases, run by Boston Medical Center at 1 site in United States.
Trial summary
This study will be the first to assess the use of an electronic health records patient portal for patients with Inflammatory Bowel Disease. Patients with Inflammatory Bowel Disease (IBD), have reduced quality of life, high rates of depression and anxiety, do not receive routine preventative health maintenance (such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- MyChart Disease Specific
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 20 Jan 2019
- 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
- Men and Women 18 years and older with a diagnosis of Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis, or Indeterminate Colitis by standard criteria) who are scheduled for an upcoming appointment at the outpatient gastroenterology clinic or infusion unit.
Who cannot join
- Non-English speaking patients
- Patients identified by their physicians as being too cognitively impaired to participate
- Patients without access to computer with internet
- Patients not expected to be in the study area for the duration of the study such as patients only seen for a one time second opinion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of MyChart for Improving Quality of Life and Patient Satisfaction in Patients With Inflammatory Bowel Disease.
This study will be the first to assess the use of an electronic health records patient portal for patients with Inflammatory Bowel Disease. Patients with Inflammatory Bowel Disease (IBD), have reduced quality of life, high rates of depression and anxiety, do not receive routine preventative health maintenance (such as vaccines) at the same rate as the general public, and have low adherence to medications. The investigators are seeking to understand whether an electronic health record patient portal (EPIC's MyChart), can be utilized to improve quality of life in this patient population.
Read the detailed description
This study will be a single site randomized control trial.
Patients will be randomized into a control arm and intervention arm. At baseline the investigators will obtain demographic data, quality of life measures, and satisfaction with MyChart for those patients who are alrealy active portal users. The control arm will receive periodic messages through MyChart that are not specific to IBD. The intervention arm will receive more specific disease related information such as IBD educational information, reminders to take their medications, and reminders to get vaccinated. The intervention arm will also receive questionnaires that assess their mood (depression and anxiety). The investigators will then inform the primary gastroenterologist for those patients in whom mild, moderate or severe depression and anxiety is identified. At the end the study, in both groups investigators will measure quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated questionnaire for measuring health-related quality of life in patients with Crohn's and Ulcerative Colitis. Secondary outcomes will include: Satisfaction with Mychart as measured by a MyChart satisfaction survey, time to referral to mental health provider for patients identified with mild, moderate, or severe depression, or anxiety (PROMIS Depression and Anxiety Questionnaires), and Vaccine uptake (using a simple yes/no questionnaire asking patients if they received Flu, PCV13 or PPSV23.
The findings of this study will allow future clinicians to better understand how a patient portal can be utilized as a tool for the management of patients with IBD. This findings may lead to increased physician and patient engagement with the MyChart patient portal.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- MyChart Disease Specific
- Keywords
- Inflammatory Bowel Disease, IBD, Electronic Health Record, Patient Portal, Quality of Life
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyChart Disease SpecificBehavioural
Subjects receive targeted IBD information and reminders as well as mood questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| MyChart Intervention | Experimental | Subjects in the control arm will be enrolled in MyChart during the consent process and receive MyChart Disease Specific targeted IBD information and reminders as well as mood questionnaires. At week 2 subjects will receive reminders to get vaccinated with another reminder sent at 3 months. At month 1, subjects will receive the Promis Adult Short Form questionnaires for depression and anxiety through MyChart. If a subject is identified as having mild, moderate or a severe mood disorder a message will be sent to their gastroenterologist with a recommendation to discuss the results with the patient and to consider a referral to mental health services. Subjects will also receive educational information about IBD every 6 weeks along with reminders to take their medications. Receives: Behavioral: MyChart Disease Specific |
| Usual Care | No intervention | Subjects in the control arm will be enrolled in MyChart during the consent process if they are not previously enrolled. Enrollment in MyChart will provide them with access to their medical record and the ability to send or receive messages with their gastroenterologist or any other providers they see at our institution. For patients with IBD it is standard practice to discuss medication adherence, vaccinations, and their mood at each appointment. Subjects will receive generic, non-IBD related messages through MyChart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life based on the SIBDQ
Quality of life will be measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) which is a 10 item health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (scores can range from 10-70, poor to good HRQoL).
Measured: 6 months
Secondary outcomes (4)
Satisfaction with MyChart
The 14 item embedded MyChart Satisfaction Survey will be used to measure satisfaction. Responses for 12 of the questions are answered on a scale of 0 to 10 where 10=Strongly Agree, 5=Neither Agree nor Disagree, and 0=Strongly Disagree, so the higher the score for those questions the greater the satisfaction. there is also a question about the number of times myChart was used and an open-ended comments question..
Measured: 6-months
Influenza vaccine uptake
To measure vaccine uptake for flu the patients will be asked if they received the flu shot in the previous year. A chart review will be done to confirm the self reported information.
Measured: 6-months
Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake
To measure PCV13, PPSV23 vaccine uptake for pneumococcal pneumonia the patients will be asked if they received the vaccine in the previous year. A chart review will be done to confirm the self reported information.
Measured: 6-months
Time to Referral for Behavioral Health
After a patient has been identified as having anxiety or depression and a message has been sent to their healthcare provider the time it takes the provider to refer the patient to behavioral health will be measured.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start15 Nov 2017
- Primary completion20 Jan 2019
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Reich, Boston Medical Center
- Investigators
- Jason Reich, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241992
- Sponsor's protocol ID
- H-35695
- Acronym
- MyIBD
- Status last verified
- Jan 2019
- First submitted
- 4 Aug 2017
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of MyChart for Improving Quality of Life and Patient Satisfaction in Patients With Inflammatory Bowel Disease.
- ClinicalTrials.gov ID
- NCT03241992
- Acronym / sponsor ID
- MyIBD / H-35695
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Disease, IBD, Electronic Health Record, Patient Portal, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 8 Aug 2017 (actual)
- 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.
This study will be the first to assess the use of an electronic health records patient portal for patients with Inflammatory Bowel Disease. Patients with Inflammatory Bowel Disease (IBD), have reduced quality of life, high rates of depression and anxiety, do not receive routine preventative health maintenance (such as vaccines) at the same rate as the general public, and have low adherence to medications. The investigators are seeking to understand whether an electronic health record patient portal (EPIC's MyChart), can be utilized to improve quality of life in this patient population.
Detailed description
This study will be a single site randomized control trial.
Patients will be randomized into a control arm and intervention arm. At baseline the investigators will obtain demographic data, quality of life measures, and satisfaction with MyChart for those patients who are alrealy active portal users. The control arm will receive periodic messages through MyChart that are not specific to IBD. The intervention arm will receive more specific disease related information such as IBD educational information, reminders to take their medications, and reminders to get vaccinated. The intervention arm will also receive questionnaires that assess their mood (depression and anxiety). The investigators will then inform the primary gastroenterologist for those patients in whom mild, moderate or severe depression and anxiety is identified. At the end the study, in both groups investigators will measure quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated questionnaire for measuring health-related quality of life in patients with Crohn's and Ulcerative Colitis. Secondary outcomes will include: Satisfaction with Mychart as measured by a MyChart satisfaction survey, time to referral to mental health provider for patients identified with mild, moderate, or severe depression, or anxiety (PROMIS Depression and Anxiety Questionnaires), and Vaccine uptake (using a simple yes/no questionnaire asking patients if they received Flu, PCV13 or PPSV23.
The findings of this study will allow future clinicians to better understand how a patient portal can be utilized as a tool for the management of patients with IBD. This findings may lead to increased physician and patient engagement with the MyChart patient portal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyChart Intervention | Experimental | Behavioral: MyChart Disease SpecificSubjects in the control arm will be enrolled in MyChart during the consent process and receive MyChart Disease Specific targeted IBD information and reminders as well as mood questionnaires. At week 2 subjects will receive reminders to get vaccinated with another reminder sent at 3 months. At month 1, subjects will receive the Promis Adult Short Form questionnaires for depression and anxiety through MyChart. If a subject is identified as having mild, moderate or a severe mood disorder a message will be sent to their gastroenterologist with a recommendation to discuss the results with the patient and to consider a referral to mental health services. Subjects will also receive educational information about IBD every 6 weeks along with reminders to take their medications. |
| Usual Care | No intervention | –Subjects in the control arm will be enrolled in MyChart during the consent process if they are not previously enrolled. Enrollment in MyChart will provide them with access to their medical record and the ability to send or receive messages with their gastroenterologist or any other providers they see at our institution. For patients with IBD it is standard practice to discuss medication adherence, vaccinations, and their mood at each appointment. Subjects will receive generic, non-IBD related messages through MyChart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and Women 18 years and older with a diagnosis of Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis, or Indeterminate Colitis by standard criteria) who are scheduled for an upcoming appointment at the outpatient gastroenterology clinic or infusion unit.
Key exclusion criteria (4 listed)
- Non-English speaking patients
- Patients identified by their physicians as being too cognitively impaired to participate
- Patients without access to computer with internet
- Patients not expected to be in the study area for the duration of the study such as patients only seen for a one time second opinion
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 |
|---|---|---|
| MyChart Disease SpecificSubjects receive targeted IBD information and reminders as well as mood questionnaires. | Behavioural | MyChart Intervention |
Primary outcome
Quality of life based on the SIBDQ
Time frame: 6 months
Quality of life will be measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) which is a 10 item health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (scores can range from 10-70, poor to good HRQoL).
4 secondary outcomes
Satisfaction with MyChart
Time frame: 6-months
Influenza vaccine uptake
Time frame: 6-months
Pneumococcal pneumonia (PCV13, PPSV23) vaccine uptake
Time frame: 6-months
Time to Referral for Behavioral Health
Time frame: 6-months
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 28 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
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.
Jason Reich, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyChart Disease Specific in people with Inflammatory Bowel Diseases, run by Boston Medical Center 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 1 inclusion and 4 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 28 Jan 2019. 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. 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?
Quality of life based on the SIBDQ (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2019.