Condition category
Digestive System
Date applied
05/02/2020
Date assigned
12/02/2020
Last edited
12/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Inflammatory Bowel Disease (IBD) affects 300,000 people in the UK causing unpredictable bouts of gut inflammation, with acute illness, diarrhoea, and pain. In remission, many people with IBD live with fatigue, chronic pain, and bowel urgency/incontinence. There is no current cure for IBD, which usually starts in childhood or as a young adult. Most previous IBD research has focused on controlling inflammation. However, many people report continuing IBD-related fatigue (41%), abdominal pain (62%) and difficulty with continence (up to 75%) even when IBD is in remission. These symptoms limit peoples’ quality of life and ability to work and socialise. This study is stage three of IBD-BOOST, a National Institute of Health Research (NIHR) Programme Grant for Applied Research (PGfAR) funded programme. The overall aim of the Programme Grant is to improve the quality of life of people with IBD by reducing the burden of IBD-related fatigue, pain, and urgency/incontinence. This interventional study of a non-randomised (cohort) study is stage 3 of the IBD-BOOST programme and will test a checklist and clinical management algorithm (step by step guide for health professionals), which we have developed for identifying and managing the most common medical causes of these IBD-related symptoms. We will then address any medical issues detected. These symptoms of fatigue, pain and urgency/incontinence have a major impact on quality of life in people with IBD, but have been largely ignored by clinicians and researchers. Our programme, shaped by the concerns of our patient and clinician stakeholders, focuses on a supported online self-management intervention for these symptoms. This study will help identify participants who will be suitable for a self-management intervention and ensure that anyone displaying “red-flag” symptoms (indicating an urgent or serious medical issue) is identified for prompt treatment. It is currently unclear how useful it is to investigate these symptoms and whether symptoms will respond to correcting biomedical abnormalities. It is currently unclear how best to manage these common symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease. Many patients do not report these symptoms at all, or if they do are offered little beyond investigation and treatment of active disease. We have found in previous work that many patients do not receive what are considered “standard care” investigations or management for these symptoms. Our previous systematic literature reviews have identified many potentially reversible causes for these symptoms. Many of these, particularly the psycho-social elements, will be addressed in our online self-management programme which follows on from the current proposal within our programme grant. However, there are also “medical” causes (such as anaemia as a cause of fatigue), which could be addressed before patients enter a self-management programme.

Who can participate?
Patients aged 18 years or older, with IBD, who have completed the IBD-BOOST survey (stage 2).

What does the study involve?
Patients participating in this study will be sent a checklist to complete about their IBD-related symptoms and any tests that they have had recently. They will also be asked to compete faecal calprotectin sample sent to them with stamped addressed packaging to send to lab. Once received, a nurse or doctor from the patient’s IBD hospital will then review the completed checklist and the results of the faecal calprotectin test and use a care pathway developed by experts to decide if a phone call and possibly further tests are necessary. If the nurse or doctor feels that more information is needed, a phone call or appointment will be arranged. During this consultation, the nurse will run through a series of questions relating to the patient’s fatigue, pain and/or urgency plus any other important symptoms they may be experiencing. After the consultation, it may be suggested that the completes further tests such as a blood test. If offered any management or advice, patients will be asked to complete a questionnaire about their symptoms after 3 months to see if there has been any improvement.

What are the possible benefits and risks of participating?
Through benefiting in this study patients will be checked to see if any of their symptoms have any common medically treatable underlying causes and treated through standard care. Patients will asked to complete a faecal calprotectin sample and will receive the result. It is unlikely that participating in this study would cause any harm. Potential side effects of any interventions that you are offered by an IBD Care Team as a result of participation in this study will be discussed with the patient beforehand and should be packaged with an information sheet.

Where is the study run from?
Northwick Park Hospital (UK)

When is the study starting and how long is it expected to run for?
February 2020 to October 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Imogen Stagg (public)
imogen.stagg@kcl.ac.uk
Prof. Christine Norton (scientific)
christine.norton@kcl.ac.uk

Trial website

https://www.kcl.ac.uk/research/ibd-boost

Contact information

Type

Public

Primary contact

Miss Imogen Stagg

ORCID ID

Contact details

Florence Nightingale Faculty of Nursing
Midwifery and Palliative Care
King’s College London
57 Waterloo Road
London
SE1 8WA
United Kingdom
07428459404
imogen.stagg@kcl.ac.uk

Type

Scientific

Additional contact

Prof Christine Norton

ORCID ID

http://orcid.org/0000-0003-2259-0948

Contact details

Florence Nightingale Faculty of Nursing
Midwifery and Palliative Care
King’s College London
57 Waterloo Road
London
SE1 8WA
United Kingdom
+4420 7848 3864
christine.norton@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

RP-PG-0216-20001, IRAS 246185, CPMS 41698

Study information

Scientific title

Identifying potential medical causes of fatigue, pain and urgency in inflammatory bowel disease and optimising medical management of these causes. The IBD-BOOST OPTIMISE Study

Acronym

IBD-BOOST OPTIMISE

Study hypothesis

Of those people with IBD who experience fatigue, pain and/or faecal urgency/incontinence and express an interest in intervention for one or more of these symptoms, what proportion have patho-physiological contributors which are potentially medically treatable?

Ethics approval

Approved 01/08/2019, West Midlands - Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8284; nrescommittee.westmidlands-blackcountry@nhs.net), ref: 18/WN/0613

Study design

A non-randomised interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Inflammatory Bowel Disease

Intervention

The OPTIMISE Study will test a checklist and algorithm designed to find any medical issues which may be causing IBD-related symptoms of fatigue, pain or urgency and to ensure these are being treated as well as they can be (“Optimised”) by a patient’s NHS IBD care team.

Patients participating in this study will be sent a checklist to complete about their IBD-related symptoms and any tests that they have had recently. They will also be asked to compete faecal calprotectin sample sent to them with stamped addressed packaging to send to lab. Once received, a nurse or doctor from the patient’s IBD hospital will then review the completed checklist and the results of the faecal calprotectin test and use a care pathway developed by experts to decide if a phone call and possibly further tests are necessary. If the nurse or doctor feels that more information is needed, a phone call or appointment will be arranged. During this consultation, the nurse will run through a series of questions relating to the patient’s fatigue, pain and/or urgency plus any other important symptoms they may be experiencing. After the consultation, it may be suggested that the completes further tests such as a blood test. If offered any management or advice, patients will be asked to complete a questionnaire about their symptoms after 3 months to see if there has been any improvement.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Proportion of participants with any of the following detected via the OPTIMISE checklist, faecal calprotectin test or by the nurse/clinician following the algorithm
1. “Red flags” (indicating an urgent or serious medical issue) on checklist which require investigation
2. Active disease (defined as faecal calprotectin 200 or over and/or IBD control score 13 or under)
3. Abnormalities detected on blood test in people with fatigue
4. Irritable Bowel Syndrome or functional dyspepsia diagnosed in people with pain (by responses on checklist)
5. Untreated loose stool detected in people with urgency

Secondary outcome measures

1. Proportion of participants for whom a clinical intervention was indicated using the OPTIMISE checklist
2. Proportion of participants who declined a suggested clinical intervention
3. Proportion of participants starting a clinical intervention for these 3 symptoms
4. For those starting a clinical optimisation intervention, the cost of implementing the algorithm (clinical tests or intervention and nurse/clinician time to implement the algorithm)
5. The checklist also includes the following measures, which will be repeated at 3 months:
5.1. PROMIS Short Form v1.0 – Fatigue 4a; 4 item validated scale to measure fatigue
5.2. PROMIS Scale v1.0 - Pain Intensity 3a; 3 item validated scale to measure pain
5.3. PROMIS Scale v1.0 – Gastrointestinal Bowel Incontinence 4a; 4 item validated scale to measure bowel control
5.4. IBD-Control score; 8-item self-reported score to measure disease control from the patient's perspective
5.5. EQ-5D-5L (Quality of Life measurement); a 5-item standardised measure of health
6. Only those participants needing interventions as indicated by the algorithm, will be sent the outcome questionnaire at 3 months after return of the initial checklist and stool sample. This questionnaire will also include a free text feedback option at follow up to capture qualitative comments about the experience of completing the checklist and algorithm, and how onerous or helpful this was.
7. In addition, the nurse/clinician will complete the Optimisation CRF for each participant, this will include number of visits or telephone contacts, all tests and results and all management initiated within the algorithm. Qualitative comments on taking the participant through the process of using the checklist and algorithm will be collected here.
8. Feasibility outcomes will include number consenting but then discontinuing (with reasons if possible), completion of outcome measures, completion of CRFs.

Overall trial start date

01/10/2017

Overall trial end date

31/10/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of IBD (including patients with an ileo-anal pouch or stoma)
2. 18 years and over
3. Lives in UK and attends one of the IBD-BOOST NHS clinical sites for routine IBD care
4. Has completed the IBD-BOOST survey (stage 2) and indicated that they would like further support to help manage their symptoms
5. Ability to give informed consent and sufficient command of English to understand study documents and procedures will be assumed from response to previous survey

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

12/02/2020

Recruitment end date

30/06/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northwick Park Hospital
London North West University Healthcare NHS Trust Watford Road
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

London North West Healthcare NHS Trust

Sponsor details

R and D
7th Floor Maternity Block
Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
+44 (0)20 8869 5173
lnwh-tr.research@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.lnwh.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We will submit results for publication in multidisciplinary academic journals (such as Inflammatory Bowel Diseases and Journal of Crohn’s & Colitis) to disseminate to professional audiences. We will submit to key IBD conferences, including the UK British Society of Gastroenterology, the European Crohn’s & Colitis Organisation and the USA Digestive Diseases Week.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.

Intention to publish date

01/11/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/02/2020: Trial’s existence confirmed by NHS Health Research Authority.