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IBD Self-management Website and Home Faecal Calprotectin Monitoring

13 de septiembre de 2018 actualizado por: University Hospital Southampton NHS Foundation Trust

Feasibility and Acceptability of an Inflammatory Bowel Disease Self-management Website and Home Faecal Calprotectin Monitoring After Treatment De-escalation

6 month exploratory feasibility study to assess if a combination of MyMedicalRecord supported self-management website and a home faecal calprotectin smartphone testing kit is a feasible and acceptable means for patients to monitor for signs of relapse after treatment de-escalation.

Descripción general del estudio

Descripción detallada

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:

  1. Secure email messaging service
  2. IBD educational material
  3. Stool, nutritional and flare journals
  4. Blood and test results
  5. 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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

11

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Hampshire
      • Southampton, Hampshire, Reino Unido, SO16 6YD
        • Univesity Hospital Southampton NHS Foundation Trust

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Faecal calprotectin testing completion rates
Periodo de tiempo: 6 months
Number of patients completing monthly faecal calprotectin testing
6 months
MyMR website usage
Periodo de tiempo: 6 months
Number of patients logging in to MyMR website at least monthly
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment
Periodo de tiempo: 6 months
Number of patients recruited per month
6 months
IBD email contact
Periodo de tiempo: 6 months
Number of email messaging contacts per patient to IBD specialist nursing team
6 months
IBD flareline calls
Periodo de tiempo: 6 months
Number of IBD flareline telephone calls per patient to IBD specialist nursing team
6 months
IT support contact
Periodo de tiempo: 6 months
Number of IT support email contacts per patient
6 months
Questionnaire response rates
Periodo de tiempo: 6 months
Response rates to pre-and post-study questionnaires
6 months
Retention rate
Periodo de tiempo: 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
Periodo de tiempo: 6 months
Mean faecal calprotectin levels at 0, 4, 8, 12, 16, 20, and 24 weeks.
6 months
IBD-Control
Periodo de tiempo: 6 months
Mean IBD-Control scores at 0, 4, 8, 12, 16, 20, and 24 weeks
6 months
SIBDQ
Periodo de tiempo: 6 months
Mean quality of life (SIBDQ) scores at 0 and 26 weeks
6 months
IBD knowledge
Periodo de tiempo: 6 months
Mean IBD knowledge scores (CC-KNOW) at 0 and 26 weeks.
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de abril de 2017

Finalización primaria (Actual)

30 de abril de 2018

Finalización del estudio (Actual)

30 de junio de 2018

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2017

Primero enviado que cumplió con los criterios de control de calidad

13 de septiembre de 2018

Publicado por primera vez (Actual)

14 de septiembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

13 de septiembre de 2018

Última verificación

1 de septiembre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • RHM MED1269

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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