The Nori Health App

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.

Study Overview

• Status: Terminated
• Conditions: Crohn Disease; Ulcerative Colitis; IBD
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboudumc
  • Tilburg, Netherlands
    • Elisabeth-TweeSteden Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Use of the Nori Health app during the study period, standard care	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.
No Intervention: Control group; No use of the Nori Health app during the study period, standard care

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: Radboud University Medical Center; Elisabeth-TweeSteden Ziekenhuis

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Pilot; Qualitative component
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: Nori_Health

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No