IBDNCT05474742
The Nori Health App
A study testing The Nori Health app in people with IBD and Crohn Disease, run by UMC Utrecht at 2 sites in Netherlands.
Trial summary
A multicenter, randomized controlled trial with an embedded pilot and qualitative component to investigate the effects of the Nori Health app. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD, Crohn Disease, Ulcerative Colitis
- What is being tested?
- The Nori Health app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- 25 Apr 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Radboudumc
Nijmegen
Elisabeth-TweeSteden Ziekenhuis
Tilburg
About this study
Official title: The Nori Health App: (Pilot) Randomized Controlled Trial
A multicenter, randomized controlled trial with an embedded pilot and qualitative component to investigate the effects of the Nori Health app.
Read the detailed description
RATIONALE Inflammatory bowel disease (IBD) is an umbrella term used to describe diseases that involve chronic inflammation of the gastrointestinal tract. Although progress in treatment has been made over the past two decades, IBD continues to profoundly affect patients' quality of life. Since patients with IBD have to deal with their disease's complex and unpredictable nature 24 hours a day, it is important that they have access to self-management support outside the hospital. Nori Health aims to provide this support with an app that consists of an artificial intelligence-driven chatbot and 6-week education program.
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
- IBD, Crohn Disease, Ulcerative Colitis
- Being tested
- The Nori Health app
- Keywords
- Randomized Controlled Trial, Pilot, Qualitative component
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Nori Health appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Use of the Nori Health app during the study period, standard care Receives: Other: The Nori Health app |
| Control group | No intervention | No use of the Nori Health app during the study period, standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation Measure (PAM)
Measure of patient activation for self-management. Scale from 0 to 100, higher scores mean a higher level of patient activation for self-management (=better outcome).
Measured: 6 weeks follow-up
Secondary outcomes (4)
Patient Activation Measure (PAM)
Measure of patient activation for self-management. Scale from 0 to 100, higher scores mean a higher level of patient activation for self-management (=better outcome).
Measured: 12 and 20 weeks follow-up
Inflammatory Bowel Disease (IBD)-control questionnaire
Measure of disease control. Scale from 0 to 16, higher scores mean a higher level of disease control (=better outcome).
Measured: 6, 12 and 20 weeks follow-up
EuroQol-5 dimension questionnaire (EQ-5D)
Measure of quality of life. Scale from 0 to 100, higher scores mean a higher quality of life (=better outcome).
Measured: 6, 12 and 20 weeks follow-up
Healthcare utilization
Brief questionnaire with 5 close-ended questions on healthcare utilizatio, using a nominal scale (e.g., yes/no).
Measured: 6, 12 and 20 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start25 Apr 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: bankruptcy app owner
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis, Radboud University Medical Center
- Responsible party
- Principal investigator, Elke Mathijssen, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474742
- Sponsor's protocol ID
- Nori_Health
- Status last verified
- Dec 2023
- First submitted
- 8 Jul 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nori Health App: (Pilot) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05474742
- Acronym / sponsor ID
- Nori_Health
- Conditions
- IBD, Crohn Disease, Ulcerative Colitis
- Keywords
- Randomized Controlled Trial, Pilot, Qualitative component
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: bankruptcy app owner
- Enrolment
- 50 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis, Radboud University Medical Center
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized controlled trial with an embedded pilot and qualitative component to investigate the effects of the Nori Health app.
Detailed description
RATIONALE Inflammatory bowel disease (IBD) is an umbrella term used to describe diseases that involve chronic inflammation of the gastrointestinal tract. Although progress in treatment has been made over the past two decades, IBD continues to profoundly affect patients' quality of life. Since patients with IBD have to deal with their disease's complex and unpredictable nature 24 hours a day, it is important that they have access to self-management support outside the hospital. Nori Health aims to provide this support with an app that consists of an artificial intelligence-driven chatbot and 6-week education program.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: The Nori Health appUse of the Nori Health app during the study period, standard care |
| Control group | No intervention | –No use of the Nori Health app during the study period, standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Nori Health appThe 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. | Other | Intervention group |
Primary outcome
Patient Activation Measure (PAM)
Time frame: 6 weeks follow-up
Measure of patient activation for self-management. Scale from 0 to 100, higher scores mean a higher level of patient activation for self-management (=better outcome).
4 secondary outcomes
Patient Activation Measure (PAM)
Time frame: 12 and 20 weeks follow-up
Inflammatory Bowel Disease (IBD)-control questionnaire
Time frame: 6, 12 and 20 weeks follow-up
EuroQol-5 dimension questionnaire (EQ-5D)
Time frame: 6, 12 and 20 weeks follow-up
Healthcare utilization
Time frame: 6, 12 and 20 weeks follow-up
Results and safety
The study was stopped early (reason given: bankruptcy app owner). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 40243391Tiles-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Nori Health app in people with IBD and Crohn Disease, run by UMC Utrecht at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: bankruptcy app owner). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation Measure (PAM) (time frame: 6 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.