- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03671980
IBD Self-management Website and Home Faecal Calprotectin Monitoring
Feasibility and Acceptability of an Inflammatory Bowel Disease Self-management Website and Home Faecal Calprotectin Monitoring After Treatment De-escalation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
IBD can be challenging to manage as disease flares are often unpredictable and rarely coincide with scheduled outpatient appointments. Websites are a novel way of assisting patients to take more control over monitoring and managing symptoms and have been shown to improve outcomes in some chronic diseases. The My Medical Record (MyMR) webiste was developed to help patients learn about IBD, access test results, monitor symptoms, and manage their medications, with email support from the IBD team.
The use of home faecal calprotectin monitoring will also be explored. This marker of IBD activity is normally performed in hospital laboratories and becomes elevated before the onset of clinical symptoms of an IBD flare. New technologies enable patients to perform the test at home with the aid of a smartphone application.
A 6 month exploratory feasibility study will be conducted to assess if a combination of MyMR and a home faecal testing kit is a feasible and acceptable means for patients to monitor their illness. Their use will be targeted to patients who have recently stopped (or reduced) a treatment for IBD, as up to 50% of these patients may have a disease flare within a year.
Interventions
- Clinic appointments Study participants will not be required to attend any routine outpatient follow up appointments for the 6 month study period, after which they will be reviewed by a member of the IBD team.
- Questionnaires and interviews Partcipants will receive questionnaires and a sample will also undergo interviews to explore their views regarding the website and stool test.
- Website
Participants will be encouraged to use all functions of the website at least monthly:
- Secure email messaging service
- IBD educational material
- Stool, nutritional and flare journals
- Blood and test results
Faecal calprotectin monitoring - monthly testing (or sooner if symptoms of a flare-up) using QuantonCal home faecal calprotectin smartphone application. Participants will test and monitor their FC levels monthly. The results will be overseen by the IBD team who will make contact within a week in the event of abnormal results if the participant has not already done so.
- Blood tests All participants will have a routine blood test at 0 and 6 months. Those taking azathioprine, mercaptopurine and methotrexate should continue regular blood monitoring (minimum of 3 monthly FBC, U&E, LFT and CRP) as usual practice. Participants will be provided with blood test results and explanations of their significance via MyMR. The results will be overseen by the IBD team who will make contact within a week in the event of abnormal results if the patient has not already done so.
- Safety Patients can contact the IBD team the email messaging service at any time for advice and support.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Hampshire
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Southampton, Hampshire, Royaume-Uni, SO16 6YD
- Univesity Hospital Southampton NHS Foundation Trust
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults aged ≥ 18 years currently under secondary care outpatient follow up for IBD
- Diagnosed with IBD at least one year prior to study enrolment (to ensure patients are familiar with their disease and treatments)
- Stopped or reduced the dose of one or more treatments for IBD (for any reason) within the last 8 weeks
- Able to understand English and provide written consent.
- Own, or have regular (at least weekly) access to a smartphone +/- personal computer with internet
Exclusion Criteria:
- Inability to read, understand informed consent
- Inability to use a smartphone
- Likely requirement of IBD surgery within the study period
- Ileostomy
- Pregnancy or planned pregnancy within next 6 months
- Terminal illness with limited (< 1year) life expectancy
- Current participation in another IBD research study
- Any reason, in the opinion of the investigators, which is likely to make the patient unsuitable for the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Web-intervention
30 participants using a self-management website and home faecal calprotectin smartphone monitoring instead of usual outpatient follow up as a means of managing their inflammatory bowel disease for 6 months after stopping an IBD medication.
|
Website comprising patient records, blood and other test results, useful information on IBD, and messaging service to communicate with IBD team, plus home smartphone faecal calprotectin monitoring.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Faecal calprotectin testing completion rates
Délai: 6 months
|
Number of patients completing monthly faecal calprotectin testing
|
6 months
|
MyMR website usage
Délai: 6 months
|
Number of patients logging in to MyMR website at least monthly
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Recruitment
Délai: 6 months
|
Number of patients recruited per month
|
6 months
|
IBD email contact
Délai: 6 months
|
Number of email messaging contacts per patient to IBD specialist nursing team
|
6 months
|
IBD flareline calls
Délai: 6 months
|
Number of IBD flareline telephone calls per patient to IBD specialist nursing team
|
6 months
|
IT support contact
Délai: 6 months
|
Number of IT support email contacts per patient
|
6 months
|
Questionnaire response rates
Délai: 6 months
|
Response rates to pre-and post-study questionnaires
|
6 months
|
Retention rate
Délai: 6 months
|
Study retention rate (target 80%).
Study retention will be defined as successful completion of at least 5 out of 7 home faecal calprotectin tests, with no periods without login to website of greater than 3 consecutive months.
|
6 months
|
Calprotectin levels
Délai: 6 months
|
Mean faecal calprotectin levels at 0, 4, 8, 12, 16, 20, and 24 weeks.
|
6 months
|
IBD-Control
Délai: 6 months
|
Mean IBD-Control scores at 0, 4, 8, 12, 16, 20, and 24 weeks
|
6 months
|
SIBDQ
Délai: 6 months
|
Mean quality of life (SIBDQ) scores at 0 and 26 weeks
|
6 months
|
IBD knowledge
Délai: 6 months
|
Mean IBD knowledge scores (CC-KNOW) at 0 and 26 weeks.
|
6 months
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RHM MED1269
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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