Inflammatory Bowel DiseasesNCT03958266
MyIBD Care - Feasibility Study
An observational study of Inflammatory Bowel Diseases, run by Barts & The London NHS Trust.
Trial summary
The aim of this study is appraise the safety and feasibility of utilising a novel mobile phone application and linked clinical platform to replace and enhance traditional outpatient appointments for patients with Inflammatory Bowel Diseases. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- MyIBD Care
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Dec 2020
- Phase
- Observational
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stable patients with Inflammatory Bowel disease as stipulated above recruited in out-patients and infusion clinics
Who may be able to join
- • Any patient 16-80 years of age at inclusion
- Established diagnosis of IBD (including UC, CD, inflammatory bowel disease of uncertain aetiology (IBD-U) and inflammation of an ileo-anal pouch (pouchitis))
- for more than 6 months prior to enrolment
- Has a smart phone device with access to the Apple AppStore or Google Play Store
- On stable medication by which we mean
- No change in oral 5-ASA dose in the last 1 month. Note, addition of 'as required' topical 5-ASA therapy is permitted
Show all 11Show fewer
- Any revent oral corticosteroids must have been finished within 4 weeks. Note
- No change in immunomodulator dose for 3 months
- No change in biologic (Adalimumab, Infliximab, Ustekinumab and Vedolizumab) regime for 8 weeks
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol.
- Must be able to understand and be willing to provide written informed consent
Who cannot join
- • Currently taking part in a clinical trial of an Investigation Medical Procedure
- Significant psychiatric morbidity
- Patients likely to change IBD team within the next 12 months
- Patients taking Cyclosporine or Tacrolimus
About this study
Official title: A Feasibility Study of a Novel Mobile Phone Application in the Long Term Management of Patients With Inflammatory Bowel Diseases
The aim of this study is appraise the safety and feasibility of utilising a novel mobile phone application and linked clinical platform to replace and enhance traditional outpatient appointments for patients with Inflammatory Bowel Diseases. The goal of this study is to demonstrate whether the platform can reduce the costs of managing patients on complex immunomodulators and biologic therapies whilst maintaining safety monitoring such as clinical patient reported outcome measures (PROMs), haematological and biochemical tests.
Read the detailed description
15 million people in the England suffer from long term conditions (LTCs). Furthermore, the number of people with three or more LTC's has risen from 1.9 million people in 2008 to 2.9 million in 2018. And with the growing number of people suffering from these conditions, the pressure grows for health care providers to provide long term solutions to meet this increase in demand.
Inflammatory Bowel Disease (IBD) is an exemplar for LTCs, requiring frequent routine appointments, an ongoing testing regimen and costly pharmacological intervention. Moreover, people living with Crohn's disease (CD) or Ulcerative Colitis (UC) are often young and report that their condition leads to a significant reduction in quality of life (QOL) even when symptoms are relatively well-controlled. Patients present with diarrhoea, abdominal pain, weight loss and other symptoms that have a significant impact on quality of life (taking into account social functioning, employment status, psychological distress). The condition has an estimated prevalence of 0.3% in North America, Northern Europe and Oceania (1) with a substantial direct and indirect costs. The majority of patients require lifelong medication and are followed up in secondary care. Like many immune mediated inflammatory conditions, it is a disease of relapse and remission. At times of relapse patients require rapid access to specialist advice, managing flares early leads to better outcomes such as returning to work or daily activities and avoids costly admission to hospital.
Up to 76% of patients with CD and 51% with UC, will need immunomodulators (thiopurines or methotrexate) which require regular blood monitoring at minimum 4 times per year to screen for side effects of myeloid and hepatotoxicity (2). Patients on sub-cutaneous biologic medications such as adalimumab, golimumab and Ustekinumab also require regular blood monitoring which often necessitates clinic visits. In a recent nationwide survey of 2400 consecutive outpatient appointments in a wide variety of hospitals throughout England and Scotland up to 75% of patients were deemed to be in a quiescent or mildly active phase of disease (2). The majority of those patients are being seen in outpatients based on an antiquated model of routine follow up appointments, with dates of 2, 3, 4, 6 and 12-month intervals chosen either to have safety-based blood tests or a date arbitrarily chosen by clinician or patient. Appointments such as these rarely reflect a clinical need and lead to an inflexible system in which patients Clinicians at King's College Hospital wanted to explore whether digital self-management could be an effective way of reducing the burden the condition places on the patient and on the health system. Using the My IBD Care app, they provided patients with a convenient digital touchpoint for their treatment, facilitating easy access to information, including their care plan, health record and self-management content; and digital contact with hospital staff via an app.
From a hospital perspective, self-managing patients cost less to treat and place less of a burden on hospital appointments, thereby contributing to shorter waiting times. Moreover, My IBD Care allows patients to submit PROMs to their clinical teams remotely and in real time, allowing clinical staff to monitor their status and intervene as required.
Scientifically validated digital therapeutics exist for diabetes, cardiovascular disease and sleeping disorders, however there are none addressing the complex, costly challenges of inflammatory conditions.
In the context of these conditions - which include Crohn's, ulcerative colitis, inflammatory arthritis and psoriasis (UK TAM c3.5m people) - a digital therapeutic is digitally-supported behaviour change, tailored to the alleviation of symptoms such as pain, fatigue and anxiety. Importantly, for a therapeutic to be accepted as such, an evidence-based approach is required.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- MyIBD Care
- 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.
MyIBD CareDevice
Novel mobile phone application
| Study group | Role | What they receive |
|---|---|---|
| MyIBD Care - Study Group | Will have traditional face to face outpatient contacts replaced with a novel mobile phone application supported via a digital clinician portal Receives: Device: MyIBD Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Proportion of patients whose care can be maintained via the digital tool through the 12 month period without registering an adverse event:
Measured: 1 year
Secondary outcomes (3)
Health economic assessment
A comparison of the direct and indirect healthcare costs in the 12 month period prior to enrolling in the trial and the 12 month period of the trial
Measured: 1 year
Patient Activation Measure
A comparison of the validated PAM scores at the start and end of the study period
Measured: 1 year
IBD Related Knowledge (CCKNOW)
A comparison of the validated Crohn's and Colitis Knowledge Score at the beginning and end of the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study startJul 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Bu Hayee, PhD, FRCP, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958266
- Sponsor's protocol ID
- 266567
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
PubMed 29050646Selinger CP, Parkes GC, Bassi A, Fogden E, Hayee B, Limdi JK, Ludlow H, McLaughlin S, Patel P, Smith M, Raine T. A multi-centre audit of excess steroid use in 1176 patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2017 Nov;46(10):964-973. doi: 10.1111/apt.14334. Epub 2017 Sep 26.
PubMed 28949018
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Novel Mobile Phone Application in the Long Term Management of Patients With Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT03958266
- Acronym / sponsor ID
- 266567
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- Jul 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 May 2019 (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.
The aim of this study is appraise the safety and feasibility of utilising a novel mobile phone application and linked clinical platform to replace and enhance traditional outpatient appointments for patients with Inflammatory Bowel Diseases. The goal of this study is to demonstrate whether the platform can reduce the costs of managing patients on complex immunomodulators and biologic therapies whilst maintaining safety monitoring such as clinical patient reported outcome measures (PROMs), haematological and biochemical tests.
Detailed description
15 million people in the England suffer from long term conditions (LTCs). Furthermore, the number of people with three or more LTC's has risen from 1.9 million people in 2008 to 2.9 million in 2018. And with the growing number of people suffering from these conditions, the pressure grows for health care providers to provide long term solutions to meet this increase in demand.
Inflammatory Bowel Disease (IBD) is an exemplar for LTCs, requiring frequent routine appointments, an ongoing testing regimen and costly pharmacological intervention. Moreover, people living with Crohn's disease (CD) or Ulcerative Colitis (UC) are often young and report that their condition leads to a significant reduction in quality of life (QOL) even when symptoms are relatively well-controlled. Patients present with diarrhoea, abdominal pain, weight loss and other symptoms that have a significant impact on quality of life (taking into account social functioning, employment status, psychological distress). The condition has an estimated prevalence of 0.3% in North America, Northern Europe and Oceania (1) with a substantial direct and indirect costs. The majority of patients require lifelong medication and are followed up in secondary care. Like many immune mediated inflammatory conditions, it is a disease of relapse and remission. At times of relapse patients require rapid access to specialist advice, managing flares early leads to better outcomes such as returning to work or daily activities and avoids costly admission to hospital.
Up to 76% of patients with CD and 51% with UC, will need immunomodulators (thiopurines or methotrexate) which require regular blood monitoring at minimum 4 times per year to screen for side effects of myeloid and hepatotoxicity (2). Patients on sub-cutaneous biologic medications such as adalimumab, golimumab and Ustekinumab also require regular blood monitoring which often necessitates clinic visits. In a recent nationwide survey of 2400 consecutive outpatient appointments in a wide variety of hospitals throughout England and Scotland up to 75% of patients were deemed to be in a quiescent or mildly active phase of disease (2). The majority of those patients are being seen in outpatients based on an antiquated model of routine follow up appointments, with dates of 2, 3, 4, 6 and 12-month intervals chosen either to have safety-based blood tests or a date arbitrarily chosen by clinician or patient. Appointments such as these rarely reflect a clinical need and lead to an inflexible system in which patients Clinicians at King's College Hospital wanted to explore whether digital self-management could be an effective way of reducing the burden the condition places on the patient and on the health system. Using the My IBD Care app, they provided patients with a convenient digital touchpoint for their treatment, facilitating easy access to information, including their care plan, health record and self-management content; and digital contact with hospital staff via an app.
From a hospital perspective, self-managing patients cost less to treat and place less of a burden on hospital appointments, thereby contributing to shorter waiting times. Moreover, My IBD Care allows patients to submit PROMs to their clinical teams remotely and in real time, allowing clinical staff to monitor their status and intervene as required.
Scientifically validated digital therapeutics exist for diabetes, cardiovascular disease and sleeping disorders, however there are none addressing the complex, costly challenges of inflammatory conditions.
In the context of these conditions - which include Crohn's, ulcerative colitis, inflammatory arthritis and psoriasis (UK TAM c3.5m people) - a digital therapeutic is digitally-supported behaviour change, tailored to the alleviation of symptoms such as pain, fatigue and anxiety. Importantly, for a therapeutic to be accepted as such, an evidence-based approach is required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyIBD Care - Study Group | – | Device: MyIBD CareWill have traditional face to face outpatient contacts replaced with a novel mobile phone application supported via a digital clinician portal |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stable patients with Inflammatory Bowel disease as stipulated above recruited in out-patients and infusion clinics
Key inclusion criteria (11 listed)
- • Any patient 16-80 years of age at inclusion
Key exclusion criteria (4 listed)
- • Currently taking part in a clinical trial of an Investigation Medical Procedure
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 |
|---|---|---|
| MyIBD CareNovel mobile phone application | Device | MyIBD Care - Study Group |
Primary outcome
Adverse events
Time frame: 1 year
Proportion of patients whose care can be maintained via the digital tool through the 12 month period without registering an adverse event:
3 secondary outcomes
Health economic assessment
Time frame: 1 year
Patient Activation Measure
Time frame: 1 year
IBD Related Knowledge (CCKNOW)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 29050646Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
- Background: PubMed 28949018Selinger CP, Parkes GC, Bassi A, Fogden E, Hayee B, Limdi JK, Ludlow H, McLaughlin S, Patel P, Smith M, Raine T. A multi-centre audit of excess steroid use in 1176 patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2017 Nov;46(10):964-973. doi: 10.1111/apt.14334. Epub 2017 Sep 26.
- Individual participant dataSharing planned: No
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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.
Bu Hayee, PhD, FRCP principal investigator
King's College Hospital NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Barts & The London NHS Trust.
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 11 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: withdrawn, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse events (time frame: 1 year). 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 NCT03958266, which also lists 2 linked publications.
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 10 Feb 2023.