Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179563
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-05
Brief Title:
TOD-IBD Empowering Patients On-Demand
Sponsor:
Franciscus Gasthuis
Organization:
Franciscus Gasthuis
Study Overview
Official Title:
Enhancing Patient Empowerment in Inflammatory Bowel Disease The Role of On-Demand Telemonitoring
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOD-IBD
Brief Summary:
Crohns disease and Ulcerative Colitis collectively known as Inflammatory Bowel Disease IBD impose a significant burden on patients and healthcare systems due to their chronic nature and complex treatment This study aims to assess the effectiveness and safety of on-demand telemonitoring as opposed to standard fixed-schedule telemonitoring in managing IBD The primary objective is to evaluate the impact of on-demand telemonitoring on the number of persistent flares over 12 months The study involves a multicenter randomized controlled trial comparing standard telemonitoring which includes regular completion of the Monitor IBD At Home questionnaire and fecal calprotectin home tests with on-demand telemonitoring where patients use the app based on their symptoms The study population includes adult patients with stable remission on maintenance therapy Disease activity measured by unplanned healthcare contacts is the primary outcome while secondary outcomes encompass clinical and patient-reported disease activity quality of life self-efficacy patient activation total healthcare contacts safety and costs Baseline characteristics include patient disease and socio-demographic factors This innovative approach has the potential to enhance patient autonomy satisfaction and self-management while reducing the overall burden on the healthcare system
Detailed Description:
Rationale Crohns 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 even 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 investigate whether using telemonitoring on-demand according to individual needs is equally effective and safe as 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
Objective The primary objective is to assess the effect of on-demand telemonitoring for IBD patients on the number persistent flares for 12 months follow up
Study design and intervention This is a multicenter randomized controlled trial comparing on-demand telemonitoring with standard telemonitoring over a period of 12 months Patients in the standard telemonitoring group follow the regular telemonitoring care pathway which involves completing the Monitor IBD At Home MIAH questionnaire and performing a fecal calprotectin FCP home test The app provides follow-up advice based on the results ofan 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
Study population Adult 18 years patients with an established diagnosis of Crohns disease or ulcerative colitis according to international guidelines on maintenance therapy with no medication changes in the last three months and in stable remission Remission will be defined as faecal calprotectin FCP 100 µgg and Harvey Bradshaw Index HBI 5 for CD and as faecal calprotectin FCP 250 µgg and Simple Clinical Colitis Activity Index scores SCCAI 3 for UC
Study parametersendpoints Disease activity defined as the number persistent flares is the primary outcome measure The secondary outcome measures include clinical disease activity number of flares 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
In this study we investigate whether using telemonitoring on-demand according to individual needs is equally effective and safe as 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
Objective The primary objective is to assess the effect of on-demand telemonitoring for IBD patients on the number persistent flares for 12 months follow up
Study design and intervention This is a multicenter randomized controlled trial comparing on-demand telemonitoring with standard telemonitoring over a period of 12 months Patients in the standard telemonitoring group follow the regular telemonitoring care pathway which involves completing the Monitor IBD At Home MIAH questionnaire and performing a fecal calprotectin FCP home test The app provides follow-up advice based on the results ofan 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
Study population Adult 18 years patients with an established diagnosis of Crohns disease or ulcerative colitis according to international guidelines on maintenance therapy with no medication changes in the last three months and in stable remission Remission will be defined as faecal calprotectin FCP 100 µgg and Harvey Bradshaw Index HBI 5 for CD and as faecal calprotectin FCP 250 µgg and Simple Clinical Colitis Activity Index scores SCCAI 3 for UC
Study parametersendpoints Disease activity defined as the number persistent flares is the primary outcome measure The secondary outcome measures include clinical disease activity number of flares 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None