The Nori Health App

NCT05474742 | Terminated

• 1 other identifier: Nori_Health
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

IBD; Crohn Disease; Ulcerative Colitis

Keywords

Randomized Controlled Trial; Pilot; Qualitative component

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient Activation Measure (PAM)

  12 and 20 weeks follow-up

• Inflammatory Bowel Disease (IBD)-control questionnaire

  6, 12 and 20 weeks follow-up

• EuroQol-5 dimension questionnaire (EQ-5D)

  6, 12 and 20 weeks follow-up

• Healthcare utilization

  6, 12 and 20 weeks follow-up

Other Outcomes (1)

• Interviews

  6-20 weeks follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

Use of the Nori Health app during the study period, standard care

Other: The Nori Health app

Control group

NO INTERVENTION

No use of the Nori Health app during the study period, standard care

Interventions

The Nori Health app OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UMC Utrecht: lead
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Radboud University Medical Center: collaborator

Study Sites (2)

Radboudumc

Nijmegen, Netherlands

Location

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 26, 2022
• Study Start: April 25, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)