The Nori Health App

Study Overview
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Brief Summary
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A multicenter, randomized controlled trial with an embedded pilot and qualitative component to investigate the effects of the Nori Health app.

Detailed Description
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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.

Official Title
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The Nori Health App: (Pilot) Randomized Controlled Trial

Conditions
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IBD, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Other: The Nori Health app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Use of the Nori Health app during the study period, standard care | Other: The Nori Health app<br>* 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.<br>|
| No Intervention: Control group<br>No use of the Nori Health app during the study period, standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 6, 12 and 20 weeks follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Pilot, Qualitative component