NCT02542917

Brief 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)).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

May 29, 2015

Last Update Submit

April 25, 2023

Conditions

Inflammatory Bowel DiseasesCrohn's DiseaseUlcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (2)

  • Any change in health locus of control score

    6 months

  • Any change in cognitive behavioural response score

    6 months

Study Arms (1)

All patients

IBDoc home test for faecal calprotectin

Device: IBDoc home test for faecal calprotectin

Interventions

IBDoc home test for faecal calprotectinDEVICE

IBDoc home test for faecal calprotectin

All patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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

You may not qualify if:

  • Participants without smartphone (Android or iOS)
  • Unable to understand English (excl. via interpreter)
  • No previous experience of submitting stool samples for faecal calprotectin measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Bu'Hussain Hayee

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

September 7, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

April 26, 2023

Record last verified: 2023-04