Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
50 participants
INTERVENTIONAL
2022-04-25
2022-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OBJECTIVES
The primary objective is to investigate whether use of the Nori Health app improves the level of patient activation for self-management in patients with IBD by comparing an intervention and (waiting-list) control group at 6 weeks after randomization. Secondary objectives are:
* To investigate whether there are any differences between the intervention and control group in the level of patient activation for self-management at 12 and 20 weeks after randomization;
* To investigate whether there are any differences between the intervention and control group in the level of disease control at 6, 12 and 20 weeks after randomization;
* To investigate whether there are any differences between the intervention and control group in quality of life at 6, 12 and 20 weeks after randomization;
* To investigate whether there are any differences between the intervention and control group in healthcare utilization at 6, 12 and 20 weeks after randomization;
* To investigate intervention fidelity at 6, 12 and 20 weeks after randomization;
* To explore the experiences of patients with IBD with use of the Nori Health app and their views on its pros and cons.
STUDY DESIGN A multicenter, randomized controlled trial with an embedded pilot and qualitative component.
STUDY POPULATION
Patients with IBD are eligible for participation if they:
* Are aged \>18 years;
* Are able to read and write the Dutch language;
* Are in the possession of a tablet or smartphone with WiFi connection.
Excluded are those with cognitive impairments or who are already familiar with use of the Nori Health app.
STUDY INTERVENTION Participants are randomized in a 1:1 ratio to the intervention or control group. Participants in the intervention group receive access to the Nori Health app for a 6-month period directly after randomization. They are free to use the Nori Health app whenever and as often as they want. Participants in the control group receive no intervention. Standard IBD care continues unchanged. After study completion, participants in the control group also receive access to the Nori Health app for a 6-month period.
STUDY PARAMETERS The level of patient activation for self-management is assessed using the patient activation measure. The IBD control questionnaire and EQ-5D are used to assess respectively the level of disease control and quality of life. Healthcare utilization is assessed with 5 close-ended questions. System data is used to assess intervention fidelity. Experiences of patients with IBD with use of the Nori Health app and their views on its pros and cons are explored by performing individual, semi-structured, telephonic interviews.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Use of the Nori Health app during the study period, standard care
The Nori Health app
The Nori Health app consist of a chatbot that instantly answers questions about topics relevant to patients with IBD and 6-week education program. The chatbot is driven by artificial intelligence and armed with state of the art scientific literature to offer to the right information to the right person at the right time. The education program is offered during the first six weeks of use. The Nori Health app then actively offers information on four fixed topics and two topics to a participant's choosing (i.e. low energy, pain, stress, mental health, hydration, exercising). It is expected from participants that they respond to this by having approximately five chat conversations of five minutes per week. Participants in the intervention group receive access to the Nori Health app for a 6-month period directly after randomization. They are free to use the Nori Health app whenever and as often as they want. Participants in the control group receive no intervention.
Control group
No use of the Nori Health app during the study period, standard care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Nori Health app
The Nori Health app consist of a chatbot that instantly answers questions about topics relevant to patients with IBD and 6-week education program. The chatbot is driven by artificial intelligence and armed with state of the art scientific literature to offer to the right information to the right person at the right time. The education program is offered during the first six weeks of use. The Nori Health app then actively offers information on four fixed topics and two topics to a participant's choosing (i.e. low energy, pain, stress, mental health, hydration, exercising). It is expected from participants that they respond to this by having approximately five chat conversations of five minutes per week. Participants in the intervention group receive access to the Nori Health app for a 6-month period directly after randomization. They are free to use the Nori Health app whenever and as often as they want. Participants in the control group receive no intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Are able to read and write the Dutch language;
* Are in the possession of a tablet or smartphone with WiFi connection.
Excluded are those with cognitive impairments or who are already familiar with use of the Nori Health app.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Elisabeth-TweeSteden Ziekenhuis
OTHER
Radboud University Medical Center
OTHER
UMC Utrecht
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elke Mathijssen
Principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radboudumc
Nijmegen, , Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Nori_Health
Identifier Type: -
Identifier Source: org_study_id