The primary objective is to assess the effect of on-demand telemonitoring for IBD patients on the cumulative incidence of persistent flares.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the cumulative incidence of persistent flares at 12
months defined as a flare for a consecutive period of >= 12 weeks. A flare is
defined as a FCP >= 250 µg/g on two consecutive measurements in a 12-week
interval and a MIAH above cut-off at least once during the period of 12 weeks.
Secondary outcome
The secondary outcome measures include: Cumulative incidence of transient
flares (lasting <12 weeks), proportion of patients in clinical and biochemical
remission at 12 months, patient-reported disease activity (IBD-Control-8),
quality of life (EQ-5D-5L, WIX, and SIBDQ), self-efficacy (IBD-SES), patient
activation (PAM-13), total number of contacts with a healthcare provider,
safety, and costs (healthcare costs, productivity costs, and patient costs).
Baseline characteristics include patient, disease, and socio-demographic
factors.
Background summary
Crohn's disease and Ulcerative Colitis (Inflammatory Bowel Disease (IBD)) are
chronic intestinal inflammations with significant impact on quality of life.
Due to their chronic nature and complex treatment requiring regular outpatient
appointments, IBD care puts a great burden on both the patient and the
healthcare system. Appropriate care, as described in the Integrated Care
Agreement published by the Dutch ministry of Health, is becoming increasingly
important. Telemonitoring is a promising alternative to regular outpatient
visits, with evidence of improving the quality of care. We combined a clinical
disease activity patient-reported outcome measure (the Monitor IBD At Home
questionnaire) with a faecal calprotectin home test (SmarTest from Preventis)
integrated in a new easy to use E-health application IBD Care Everywhere
(IBD-CE) for IBD patients to determine disease activity at home.
In this study, we are investigating whether utilizing telemonitoring on-demand
(telemonitoring at one's own discretion) is equally effective and safe compared
to telemonitoring based on a fixed schedule. This concept offers the
opportunity to align the treatment of the disease more closely with the
principles of appropriate care, which can result in improved patient autonomy,
increased satisfaction, and enhanced self-management, while simultaneously
reducing the burden on the healthcare system.
Study objective
The primary objective is to assess the effect of on-demand telemonitoring for
IBD patients on the cumulative incidence of persistent flares.
Study design
This is a pragmatic, multicenter, non-inferiority, parallel randomized
controlled trial comparing on-demand telemonitoring with standard
telemonitoring over a period of 12 months. Patients in the standard
telemonitoring group follow a regular telemonitoring care pathway, which
involves completing the Monitor IBD At Home (MIAH) questionnaire and performing
a fecal calprotectin (FCP) home test according to a fixed schedule, in
combination with the option to use it at their own discretion. The app provides
follow-up advice based on the results of an algorithm. In the on-demand
intervention group, patients can use the app at their own discretion when they
experience symptoms but are not required to perform standard measurements when
they are symptom-free. This allows them to have control over their monitoring
activities.
Intervention
Subjects will be randomised into two groups:
- Control group (standard telemonitoring): Patients will be monitored according
to a fixed telemonitoring schedule at their treating hospitals. This schedule
is based on the patient's medication type and in adherence to national and
international guidelines (35). Specific schedules corresponding to each
medication type are described in detail in chapter to utilize the
telemonitoring tool outside the fixed schedule at their own discretion in case
of symptoms.
- Intervention group (on-demand telemonitoring): Patients will have the
flexibility to use the telemonitoring application at their own discretion in
case of symptoms.
Study burden and risks
The risks of participation are negligible and the burden is minimised. No
additional visits are scheduled and no invasive examinations are performed.
Henri Dunantstraat 1
's-Hertogenbosch 5223 GZ
NL
Henri Dunantstraat 1
's-Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
- Aged >18 years.
- Confirmed IBD diagnosis according to current standards.
- Provided informed consent.
- Maintenance therapy with no medication changes in the last 3 months.
- Remission:
- Crohn*s disease
- Location = L1: Faecal calprotectin (FCP) < 150 µg/g and Harvey
Bradshaw Index (HBI) < 5 or MIAH-CD < 0.3623618
- Location > L2: Faecal calprotectin (FCP) < 250 µg/g and Harvey
Bradshaw Index (HBI) < 5 or MIAH-CD < 0.3623618
- Ulcerative Colitis: Faecal calprotectin (FCP) < 250 µg/g and Simple
Clinical Colitis Activity Index scores (SCCAI) < 3 or MIAH-CU < 0.354215
Exclusion criteria
- Presence of a stoma.
- Presence of an ileo-anal pouch or ileorectal anastomosis.
- Participating in another prospective clinical trial that interferes with this
trial.
- Have insufficient knowledge of the Dutch language to use the application.
- Do not have a smartphone or tablet with an internet connection.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06179563 |
| CCMO | NL86106.100.24 |