The Nori Health App

Ulcerative Colitis Clinical Trial

Official title:

The Nori Health App: (Pilot) Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05474742
• Other study ID #: Nori_Health
• Status: Terminated
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2023
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• IBD
• Ulcerative Colitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen
Netherlands	Elisabeth-TweeSteden Ziekenhuis	Tilburg

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Elisabeth-TweeSteden Ziekenhuis, Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interviews	Experiences of patients with IBD with use of the Nori Health app and their views on its pros and cons.	6-20 weeks follow-up
Primary	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	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
Secondary	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
Secondary	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
Secondary	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