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Inflammatory Bowel DiseasesNCT03958266

MyIBD Care - Feasibility Study

An observational study of Inflammatory Bowel Diseases, run by Barts & The London NHS Trust.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

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 groups in NCT03958266
Study groupRoleWhat they receive
MyIBD Care - Study GroupWill 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.

  1. 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)
  1. 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

  2. Patient Activation Measure

    A comparison of the validated PAM scores at the start and end of the study period

    Measured: 1 year

  3. 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.

  1. First posted22 May 2019
  2. Study startJul 2019 (estimated)
  3. Primary completionSep 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Why it stopped: COVID pandemic

Resources

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)
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 29050646
  • Selinger 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

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.

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