Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03958266 |
| Other study ID # |
266567 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2019 |
| Est. completion date |
December 2020 |
Study information
| Verified date |
May 2019 |
| Source |
Barts & The London NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
