Clinical trial NCT05474742: The Nori Health App
Official title: The Nori Health App: (Pilot) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: IBD
Crohn Disease
Ulcerative Colitis
Keywords: Randomized Controlled Trial
Pilot
Qualitative component
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Elisabeth-TweeSteden Ziekenhuis
name: Radboud University Medical Center
First posted: 2022-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Activation Measure (PAM)
timeFrame: 6 weeks follow-up
Secondary outcomes:
measure: Patient Activation Measure (PAM)
timeFrame: 12 and 20 weeks follow-up
measure: Inflammatory Bowel Disease (IBD)-control questionnaire
timeFrame: 6, 12 and 20 weeks follow-up
measure: EuroQol-5 dimension questionnaire (EQ-5D)
timeFrame: 6, 12 and 20 weeks follow-up
measure: Healthcare utilization
timeFrame: 6, 12 and 20 weeks follow-up
Other outcomes:
measure: Interviews
timeFrame: 6-20 weeks follow-up
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
Study officials:
References: