Inflammatory Bowel DiseasesNCT02542917
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
An observational study of Inflammatory Bowel Diseases and Crohn's Disease, run by King's College Hospital NHS Trust.
Trial summary
This trial will test, in a representative group of IBD patients, the acceptability of - and adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of inflammatory bowel disease (IBD)). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- IBDoc home test for faecal calprotectin
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Aug 2016
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unselected patients with any form of inflammatory bowel disease on any treatment and at any stage of disease activity (diagnosed more than 6 months prior to study entry)
Who may be able to join
- Patients with inflammatory bowel disease diagnosed at least 6 months prior to study entry
- Willing to participate in home testing and have smartphone
- Able to understand English or explanation via interpreter, and provide written consent
Who cannot join
- Participants without smartphone (Android or iOS)
- Unable to understand English (excl. via interpreter)
- No previous experience of submitting stool samples for faecal calprotectin measurement
About this study
This trial will test, in a representative group of IBD patients, the acceptability of - and adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of inflammatory bowel disease (IBD)).
Read the detailed description
Crohn's disease (CD) and ulcerative colitis (UC) are forms of inflammatory bowel disease (IBD) that require long-term monitoring. People with these conditions require regular and repeat testing, sometimes with endoscopy, to assess the state of the disease. Many centres worldwide now use a stool test called faecal calprotectin (FCALP) as an accurate reflection of endoscopic disease activity - meaning that people with IBD do not need 'routine' endoscopy to assess their disease. FCALP can also be used to give a prediction of what will happen to a person's IBD in the near future.
As such, FCALP is an excellent and highly cost-effective test in IBD. However, uptake is often low (as with all stool tests) particularly because the sample needs to be taken at home and delivered in to the laboratory or hospital to be tested. People still therefore need to make an effort to submit samples and find this inconvenient. Furthermore, treatments for IBD are increasingly being given at home (usually self-administered injections). While beneficial for people with IBD, it is more difficult to keep track of such patients in the hospital service as they attend less regularly. A test that can be done at home, while making results available to the hospital team, is therefore desirable.
New technology allows reliable testing of FCALP at home, using a smartphone app (IBDoc-TM, Buhlmann Laboratories) within a few minutes. The test kit is packaged with everything required (including gloves, sample 'capture' paper, disposal bag, etc). An instructional video is available within the app itself.
Apart from testing whether patients adhere to the testing schedule, the investigators will also compare their experiences of the IBDoc test, health anxieties, locus of control, and satisfaction vs postal and traditional 'drop-off' test. Validated questionnaires will include: GAD7, PHQ9, IBDC, CBRQ and MHLC as well as a proprietary satisfaction questionnaire at the end of the study.
- Being tested
- IBDoc home test for faecal calprotectin
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBDoc home test for faecal calprotectinDevice
IBDoc home test for faecal calprotectin
| Study group | Role | What they receive |
|---|---|---|
| All patients | IBDoc home test for faecal calprotectin Receives: Device: IBDoc home test for faecal calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to testing schedule (overall >75%)
As this is a feasibility study there is no 'outcome' measure as such; We are testing the adherence to the study protocol as the main outcome of this study
Measured: 6 months
Secondary outcomes (2)
Any change in health locus of control score
Any change in MHLC score from study start to end
Measured: 6 months
Any change in cognitive behavioural response score
Any change in CBRQ-32 score from study start to end
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 posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionAug 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bu'Hussain Hayee, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542917
- Sponsor's protocol ID
- 15/WA/0518
- Status last verified
- Apr 2023
- First submitted
- 29 May 2015
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02542917
- Acronym / sponsor ID
- 15/WA/0518
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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 trial will test, in a representative group of IBD patients, the acceptability of - and adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of inflammatory bowel disease (IBD)).
Detailed description
Crohn's disease (CD) and ulcerative colitis (UC) are forms of inflammatory bowel disease (IBD) that require long-term monitoring. People with these conditions require regular and repeat testing, sometimes with endoscopy, to assess the state of the disease. Many centres worldwide now use a stool test called faecal calprotectin (FCALP) as an accurate reflection of endoscopic disease activity - meaning that people with IBD do not need 'routine' endoscopy to assess their disease. FCALP can also be used to give a prediction of what will happen to a person's IBD in the near future.
As such, FCALP is an excellent and highly cost-effective test in IBD. However, uptake is often low (as with all stool tests) particularly because the sample needs to be taken at home and delivered in to the laboratory or hospital to be tested. People still therefore need to make an effort to submit samples and find this inconvenient. Furthermore, treatments for IBD are increasingly being given at home (usually self-administered injections). While beneficial for people with IBD, it is more difficult to keep track of such patients in the hospital service as they attend less regularly. A test that can be done at home, while making results available to the hospital team, is therefore desirable.
New technology allows reliable testing of FCALP at home, using a smartphone app (IBDoc-TM, Buhlmann Laboratories) within a few minutes. The test kit is packaged with everything required (including gloves, sample 'capture' paper, disposal bag, etc). An instructional video is available within the app itself.
Apart from testing whether patients adhere to the testing schedule, the investigators will also compare their experiences of the IBDoc test, health anxieties, locus of control, and satisfaction vs postal and traditional 'drop-off' test. Validated questionnaires will include: GAD7, PHQ9, IBDC, CBRQ and MHLC as well as a proprietary satisfaction questionnaire at the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Device: IBDoc home test for faecal calprotectinIBDoc home test for faecal calprotectin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected patients with any form of inflammatory bowel disease on any treatment and at any stage of disease activity (diagnosed more than 6 months prior to study entry)
Key inclusion criteria (3 listed)
- Patients with inflammatory bowel disease diagnosed at least 6 months prior to study entry
- Willing to participate in home testing and have smartphone
- Able to understand English or explanation via interpreter, and provide written consent
Key exclusion criteria (3 listed)
- Participants without smartphone (Android or iOS)
- Unable to understand English (excl. via interpreter)
- No previous experience of submitting stool samples for faecal calprotectin measurement
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 |
|---|---|---|
| IBDoc home test for faecal calprotectinIBDoc home test for faecal calprotectin | Device | All patients |
Primary outcome
Adherence to testing schedule (overall >75%)
Time frame: 6 months
As this is a feasibility study there is no 'outcome' measure as such; We are testing the adherence to the study protocol as the main outcome of this study
2 secondary outcomes
Any change in health locus of control score
Time frame: 6 months
Any change in cognitive behavioural response score
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 26 Apr 2023.
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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'Hussain Hayee 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 and Crohn's Disease, run by King's College Hospital 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 3 inclusion and 3 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 26 Apr 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 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?
Adherence to testing schedule (overall >75%) (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 26 Apr 2023.