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Ulcerative ColitisNCT04165265

The Use of Web-app Constant-Care in Patients With Acute Severe Ulcerative Colitis Treated With Rescue Therapy

A study testing Constant-Care in people with Ulcerative Colitis and Telemedicine, run by Nordsjaellands Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary aim is to evaluate if introduction of eHealth in its form of the web application Constant-Care (https://ibd.constant-care.com) could reduce the length of hospitalization in patients with acute severe Ulcerative Colitis treated with infliximab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis, Telemedicine
What is being tested?
Constant-Care
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteDenmark
Study dates
3 Dec 2019to 31 Dec 2021
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with the diagnosis acute severe UC/IBDU, ECCO guidelines; Bloody diarrhea ≥ 6/day plus minimum one of following: Pulse > 90/min, Temperature > 37.8 °C, Hemoglobin < 105 g/l, ESR > 30 mm/h, CRP > 30
  • Hospitalized at NOH, Hillerød
  • UC patients receiving IV glucocorticoids
  • UC patients who can read, speak and understand Danish
  • Have a smartphone
  • UC patients who can manage going on Internet
  • Above 18 years of age

Who cannot join

  • Any present enteric infection
  • Receiving per oral glucocorticoids
  • Contraindications for IFX therapy, including;
  • Former inadequate response to IFX
  • Disease relapse in spite of current treatment with IFX
  • Intolerance or unacceptable side-effects to IFX
Show all 13Show fewer
  • Active or latent TB
  • Cardiac failure (NYHA III or IV)
  • Demyelinating disorders
  • Former gastrointestinal surgery
  • UC patients with any severe mental disturbance and/or alcohol/other drug abuse
  • UC patients with language barrier
  • Below 18 years of age

Trial locations and contacts

1 site in 1 country.

Malte Rosager Hansen, Research assistant contact

+45 4829 6765

luca.malte.rosager.hansen@regionh.dk

Pia Munkholm, Professor contact

+45 4829 2078

pia.munkholm@regionh.dk

Denmark1 site, 1 recruiting

  • North Zealand University Hospital

    Frederikssund, 3600

    Luca Malte Rosager Hansen, Student, +45 48 29 67 65, luca.malte.rosager.hansen@regionh.dk

    Pia Munkholm, Professor, +45 48 29 20 78, pia.munkholm@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: Reduction in Length of Hospitalization in Patients With Acute Severe Ulcerative Colitis Treated With Rescue Therapy With Infliximab by the Use of Web-app Constant-Care. One Year Follow-up, Inclusive Colectomy Rate.

The primary aim is to evaluate if introduction of eHealth in its form of the web application Constant-Care (https://ibd.constant-care.com) could reduce the length of hospitalization in patients with acute severe Ulcerative Colitis treated with infliximab. This is relative to historical controls extracted from medical records.

Patients will self-measure on the web-application while hospitalized as well as after discharge. At the web-application different questionnaires are filled out and a fecal calprotectin (FC) analysis is performed on a smartphone. The final follow up is one year after admission.

Read the detailed description

Consecutive inclusion of patients hospitalized at North Zealand University Hospital (NOH) in Denmark between December 2019 and June 2020 with the diagnosis acute severe Ulcerative Colitis (UC) (expected 14-28 patients). The included patients will be matched with historical controls 1:3 (matched on age and sex). Controls will be extracted from medical records (2015-2019). Only historical controls who meet the inclusion criteria as well as receive Infliximab rescue therapy, when admitted to hospital due to the diagnosis acute severe UC, are included. This means that patients, who are responders to high dose glucocorticoids are excluded as historical controls.

At Day 0 all the included UC patients will receive an introduction and their own personal login to the Constant-Care (CC) web-application (Two Factor Authentication) as well as receive standard treatment with IV glucocorticoids. When the patients have received an introduction to CC, they will register their disease activity; Simple Clinical Colitis Activity index (SCCAI). This tool captures the patient's illness experience (Patient-Reported Outcomes, PROs). Furthermore, the patients are introduced and assisted with Fecal Calprotectin (FC) testing kit (CalproSmart). For this analysis, patients will receive a personal login to CalproSmart.

Beside the CC monitoring initiated at Day 0, the patient will be followed through standard monitoring (DSGH guidelines) such as vital parameters daily (minimum three times a day), conventional FC Elisa (send to Hvidovre), blood samples and the frequency of bowel movements. In addition, fecal samples will be collected from all patients to microbiome analysis for future use (I Suite nr: 03719, ID no: NOH-2015-017). A separate written informed consent is collected when patient want to participate in future research with microbiome analysis. Furthermore, the patients' medical history, disease course and Montreal classification will be examined. At follow-up (week 52) it is considered if the patient had a colectomy.

While hospitalized patients register in CC everyday as well as perform the FC test with CalproSmart. This is continued until discharge or whenever the patient is categorized as "green". A patient is classified as "green" when either SCCAI or FC are in the green zone (cut-off values: SCCAI; ≤ 2 (green), > 2 - 5 (yellow) and > 5 (red), FC; ≤ 200 mg/kg (green), 201-600 mg/kg (yellow), > 600 (red)).

On or around Day 3 it is considered if patient is a responder to the initial treatment with glucocorticoids. In case only partial or no response is observed the patient is considered rescue therapy (Infliximab, IFX) if no contraindications are present. This divides the patients in two arms; responders and partial/non-responders.

Both groups will continue daily registration in CC and perform FC test while admitted to hospital or until classified as "green". After discharge the responder group will register in CC and perform FC on demand in case of relapse in disease. At follow up (week 52) responders will register in CC and perform the FC test.

Partial/non-responders will, after discharge, register in CC and perform FC test once every week in the following 7 weeks. Afterwards registration is done on demand in case of relapse in disease. A final registration in CC and FC test is done at follow up.

In CC, patients will register: SCCAI, S-IBDQ, WEB-DI and FC via CalproSmart.

Being tested
Constant-Care
Keywords
Hospitalization, Reduction in stay, Ulcerative Colitis, Inflammatory Bowel Disease, eHealth, Colectomy, Rescue therapy, Infliximab
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Constant-CareDevice

    Constant-Care (CC) (https://ibd.constant-care.com) is a web-application and contains an education and a disease monitoring package. An algorithm is established in the disease monitoring package, which consist of two variables; fecal calprotectin (FC) and a disease activity questionnaire (validated), Simple Clinical Colitis Activity index (SCCAI) for UC. The FC is obtained through CalproSmart app (it only takes 18 min) and the questionnaire is filled out in CC. Afterwards, the data are analyzed by CC and presented in a Total Inflammatory Burden Score (TIBS) as well as a visual "traffic light" of disease for the patients

Study groups in NCT04165265
Study groupRoleWhat they receive
Responders and Partial/non-respondersExperimentalThe definition of responders to glucocorticoids is: "Bowel movements ≤ 3/day without blood and normalization of CRP". In the study, this is supported by CC. The definition of non-responders is: "Bowel movements > 8/day or 3-8/day and CRP > 45 mg/l." The decision if the patient is a non-responder is supported by CC. Questionnaires in CC and FC analysis with CalproSmart are performed every day until discharge or when classified as "green" in CC. After discharge questionnaires in CC and FC analysis are performed once every week in the following 7 weeks and a final registration at week 52. In case of disease relapse between week 7 and 52 registration in CC and FC analysis are performed on demand. Fecal samples for future use (biobank) and FC Elisa as well as blood samples are done before administration of IFX (week 2 and 6). At follow-up (week 52) it is considered whether the patient underwent colectomy or not.
Receives: Device: Constant-Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in length of hospitalization due to the use of Constant-Care

    The primary aim is to evaluate if introduction of eHealth in its form of the web application Constant-Care could change the length of hospitalization in patients with acute severe Ulcerative Colitis treated with infliximab. This is relative to historical controls extracted from medical records.

    Measured: One year after inclusion

Secondary outcomes (6)

  1. Quality of Life (S-IBDQ)

    S-IBDQ is a clinical tool, which measure the subjective health related quality of life (HRQoL) in patients with an IBD diagnosis. The questionnaire compromises 10 questions derived from the full version IBDQ. Questions cover patients physical health, psychological health, social relationships and environment. The total score ranges from 10 to 70, where 70 indicates best health (classified as "green" in CC when S-IBDQ > 50). Evidence has shown that the tool is able to discriminate between patients with active and inactive disease. Furthermore, evidence indicates that S-IBDQ correlates with other clinical tools such as the SCCAI.

    Interesting questions concerning the S-IBDQ are: How will the S-IBDQ change over time (responder and non-responder)? What are the differences between responders and non-responders? What is the impact of S-IBDQ in relation to clinical decision-making?

    Measured: One year after inclusion

  2. Disability index (WEB-DI), The IBD Disk

    The IBD Disk was developed from selected elements from the IBD disability index (IBD-DI), which are most likely to be important in assessing a patient's disease burden and at the same time had relevance to both the patient and physician. The IBD-DI consists of 28 questions and is a physician- administrated tool, which evaluates the IBD patients' functional status. The IBD Disk consists of 10 elements, which are ranked from 0 to 10; Abdominal pain, regulating defecation, interpersonal interactions, education/work, sleep, energy, emotions, body image, sexual functions and joint pain. The result is visually illustrated in a disc.

    Interesting questions concerning the WEB-DI are: How will the WEB-DI change over time (responder and non-responder)? What are the differences between responders and non-responders? What is the impact of WEB-DI in relation to clinical decision-making?

    Measured: One year after inclusion

  3. Fecal calprotectin level

    FC release is related to cell stress/damage and is a very sensitive marker for inflammation in the gastrointestinal tract. It is available as a non-invasive tool for monitoring and adjustment of treatment in UC as it relates to relapse in the disease. Furthermore, there is a high correlation between FC level measured in stool and the histological and endoscopic findings. In the study FC would be analyzed with conventional FC Elisa and by the use of Calpro Smart

    Interesting questions concerning the fecal calprotectin level are: How will the calprotectin level change over time (responder and non-responder)? What are the differences between responders and non-responders? What is the lead time between fecal calprotectin determination via CalproSmart and conventional Elisa? What is the impact of the immediate calprotectin analysis via CalproSmart to clinical decision-making?

    Measured: One year after inclusion

  4. Time to clinical decision-making (days)

    The conventional treatment of patients with acute severe UC is IV glucocorticoids. No response to glucocorticoids is associated with colectomy in 85% of cases during the actual admission if rescue therapy is not initiated. Infliximab, which is one of the therapeutic alternatives, has been found safe and effective as rescue therapy (reduction in colectomy rate) in patients with acute moderate to severe UC. The response to the treatment with glucocorticoids is evaluated at Day 3-5. If no or only partial response is observed, it is considered if the patient is a candidate for the rescue therapy with IFX between Day 3 and 5. However, Day 3-5 is rarely being withhold in everyday life in hospital.

    Interesting questions concerning the time to clinical decision-making: Will time to clinical decision-making change relative to historical controls? This would be an estimate relative to the length of hospitalization. What are factors that determine whether to start infliximab or not?

    Measured: One year after inclusion

  5. Colectomy rate (at week 52)

    Will the colectomy rate change (decrease/increase/unaffected) compared with the historical controls?

    Measured: One year after inclusion

  6. Disease course types

    The disease course of UC patients is varying. Overall, they are considered in four subgroups characterized based on relations between periods of active disease and remission. The groups are as follows:

    1. High disease activity in the beginning, followed by decreasing disease activity
    2. Low disease activity in the beginning, followed by increasing disease activity
    3. Chronic disease course with constant disease activity
    4. Chronic disease course with fluctuations in disease activity

    Interesting questions concerning disease course types: Are the patients disease course changed over time? Will there be any differences between responders and non-responders? Does the initial disease course have an impact on the outcome of the admission?

    Measured: One year after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2019
  2. Study start3 Dec 2019
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Case-control trial
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04165265
Sponsor's protocol ID
H-19047104
Status last verified
Nov 2019
First submitted
8 Nov 2019
Last updated
5 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Elkjaer M, Shuhaibar M, Burisch J, Bailey Y, Scherfig H, Laugesen B, Avnstrom S, Langholz E, O'Morain C, Lynge E, Munkholm P. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided 'Constant-care' approach. Gut. 2010 Dec;59(12):1652-61. doi: 10.1136/gut.2010.220160.

    PubMed 21071584

  • Pedersen N, Thielsen P, Martinsen L, Bennedsen M, Haaber A, Langholz E, Vegh Z, Duricova D, Jess T, Bell S, Burisch J, Munkholm P. eHealth: individualization of mesalazine treatment through a self-managed web-based solution in mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2014 Dec;20(12):2276-85. doi: 10.1097/MIB.0000000000000199.

    PubMed 25248002

  • de Jong MJ, van der Meulen-de Jong AE, Romberg-Camps MJ, Becx MC, Maljaars JP, Cilissen M, van Bodegraven AA, Mahmmod N, Markus T, Hameeteman WM, Dijkstra G, Masclee AA, Boonen A, Winkens B, van Tubergen A, Jonkers DM, Pierik MJ. Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial. Lancet. 2017 Sep 2;390(10098):959-968. doi: 10.1016/S0140-6736(17)31327-2. Epub 2017 Jul 14.

    PubMed 28716313

  • Silverberg MS, Satsangi J, Ahmad T, Arnott ID, Bernstein CN, Brant SR, Caprilli R, Colombel JF, Gasche C, Geboes K, Jewell DP, Karban A, Loftus EV Jr, Pena AS, Riddell RH, Sachar DB, Schreiber S, Steinhart AH, Targan SR, Vermeire S, Warren BF. Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Can J Gastroenterol. 2005 Sep;19 Suppl A:5A-36A. doi: 10.1155/2005/269076.

    PubMed 16151544

  • Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.

    PubMed 16698746

  • Dignass A, Eliakim R, Magro F, Maaser C, Chowers Y, Geboes K, Mantzaris G, Reinisch W, Colombel JF, Vermeire S, Travis S, Lindsay JO, Van Assche G. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1: definitions and diagnosis. J Crohns Colitis. 2012 Dec;6(10):965-90. doi: 10.1016/j.crohns.2012.09.003. Epub 2012 Oct 3. No abstract available.

    PubMed 23040452

  • Lane ER, Zisman TL, Suskind DL. The microbiota in inflammatory bowel disease: current and therapeutic insights. J Inflamm Res. 2017 Jun 10;10:63-73. doi: 10.2147/JIR.S116088. eCollection 2017.

    PubMed 28652796

  • Hansen JJ, Sartor RB. Therapeutic Manipulation of the Microbiome in IBD: Current Results and Future Approaches. Curr Treat Options Gastroenterol. 2015 Mar;13(1):105-20. doi: 10.1007/s11938-014-0042-7.

    PubMed 25595930

  • Bernstein CN, Forbes JD. Gut Microbiome in Inflammatory Bowel Disease and Other Chronic Immune-Mediated Inflammatory Diseases. Inflamm Intest Dis. 2017 Nov;2(2):116-123. doi: 10.1159/000481401. Epub 2017 Oct 20.

    PubMed 30018962

  • Franzosa EA, Sirota-Madi A, Avila-Pacheco J, Fornelos N, Haiser HJ, Reinker S, Vatanen T, Hall AB, Mallick H, McIver LJ, Sauk JS, Wilson RG, Stevens BW, Scott JM, Pierce K, Deik AA, Bullock K, Imhann F, Porter JA, Zhernakova A, Fu J, Weersma RK, Wijmenga C, Clish CB, Vlamakis H, Huttenhower C, Xavier RJ. Gut microbiome structure and metabolic activity in inflammatory bowel disease. Nat Microbiol. 2019 Feb;4(2):293-305. doi: 10.1038/s41564-018-0306-4. Epub 2018 Dec 10.

    PubMed 30531976

  • Burisch J, Jess T, Martinato M, Lakatos PL; ECCO -EpiCom. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013 May;7(4):322-37. doi: 10.1016/j.crohns.2013.01.010. Epub 2013 Feb 8.

    PubMed 23395397

  • Burisch J, Katsanos KH, Christodoulou DK, Barros L, Magro F, Pedersen N, Kjeldsen J, Vegh Z, Lakatos PL, Eriksson C, Halfvarson J, Fumery M, Gower-Rousseau C, Brinar M, Cukovic-Cavka S, Nikulina I, Belousova E, Myers S, Sebastian S, Kiudelis G, Kupcinskas L, Schwartz D, Odes S, Kaimakliotis IP, Valpiani D, D'Inca R, Salupere R, Chetcuti Zammit S, Ellul P, Duricova D, Bortlik M, Goldis A, Kievit HAL, Toca A, Turcan S, Midjord J, Nielsen KR, Andersen KW, Andersen V, Misra R, Arebi N, Oksanen P, Collin P, de Castro L, Hernandez V, Langholz E, Munkholm P; Epi-IBD Group. Natural Disease Course of Ulcerative Colitis During the First Five Years of Follow-up in a European Population-based Inception Cohort-An Epi-IBD Study. J Crohns Colitis. 2019 Feb 1;13(2):198-208. doi: 10.1093/ecco-jcc/jjy154.

    PubMed 30289522

  • Burisch J, Zammit SC, Ellul P, Turcan S, Duricova D, Bortlik M, Andersen KW, Andersen V, Kaimakliotis IP, Fumery M, Gower-Rousseau C, Girardin G, Valpiani D, Goldis A, Brinar M, Cukovic-Cavka S, Oksanen P, Collin P, Barros L, Magro F, Misra R, Arebi N, Eriksson C, Halfvarson J, Kievit HAL, Pedersen N, Kjeldsen J, Myers S, Sebastian S, Katsanos KH, Christodoulou DK, Midjord J, Nielsen KR, Kiudelis G, Kupcinskas L, Nikulina I, Belousova E, Schwartz D, Odes S, Salupere R, Carmona A, Pineda JR, Vegh Z, Lakatos PL, Langholz E, Munkholm P; Epi-IBD group. Disease course of inflammatory bowel disease unclassified in a European population-based inception cohort: An Epi-IBD study. J Gastroenterol Hepatol. 2019 Jun;34(6):996-1003. doi: 10.1111/jgh.14563. Epub 2019 Jan 21.

    PubMed 30562421

  • Harbord M, Eliakim R, Bettenworth D, Karmiris K, Katsanos K, Kopylov U, Kucharzik T, Molnar T, Raine T, Sebastian S, de Sousa HT, Dignass A, Carbonnel F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jul 1;11(7):769-784. doi: 10.1093/ecco-jcc/jjx009. No abstract available.

    PubMed 28513805

  • Jarnerot G, Hertervig E, Friis-Liby I, Blomquist L, Karlen P, Granno C, Vilien M, Strom M, Danielsson A, Verbaan H, Hellstrom PM, Magnuson A, Curman B. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology. 2005 Jun;128(7):1805-11. doi: 10.1053/j.gastro.2005.03.003.

    PubMed 15940615

Questions about this trial

What is this clinical trial studying?

A study testing Constant-Care in people with Ulcerative Colitis and Telemedicine, run by Nordsjaellands Hospital at 1 site in Denmark.

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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Malte Rosager Hansen, Research assistant (+45 4829 6765, luca.malte.rosager.hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in length of hospitalization due to the use of Constant-Care (time frame: One year after inclusion). 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 NCT04165265, which also lists 25 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 5 Dec 2019.

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