The Remote Monitoring of Gout Feasibility Study (ReMonit Gout)

December 6, 2024 updated by: Nina Osteras, Diakonhjemmet Hospital

The ReMonit Gout Feasibility Study

In this feasibility trial, a digital follow-up treatment strategy with patient self-management app (Urika) and remote monitoring in specialist healthcare for patients with gout will be tested.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this feasibility study various outcome measures will be assessed to determine whether the app (Urika) is viable, practical, and useful. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Norway
      • Oslo, Norway, 0319
        • Diakonhjemmet Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or non-pregnant, non-nursing female >18 years of age at screening
  • Patients with a clinical diagnosis of gout
  • Patients who fulfil the American College of Rheumatology (ACR)/EULAR classification criteria
  • Serum urate level >360 μmol/L at inclusion
  • Having a smartphone/tablet

Exclusion Criteria:

  • Contraindication for urate lowering therapy
  • Unstable medical conditions (e.g,, uncontrollable hypertension, impaired liver function); known stage 3b or higher chronic kidney disease (estimated glomerular filtration (eGFR) rate/creatinine clearance <45 mL/min); severe infection or gastrointestinal bleed
  • Major co-morbidities (e.g., malignancies, severe cardiovascular disease, severe diabetes mellitus, severe respiratory diseases)
  • Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: To determine the feasibility of a patient self-management application (Urika) in patients with gout.
The intended purpose of the app is to support self-management for patients with gout that initiate urate lowering therapy.
Device: "Urika", a self-management application for patients with gout
The self-management software application (Urika) will include information videos on gout and treatment, reminders of daily medication and blood tests, a built-in algorithm for medical dosage escalation, visualization and log of serum urate levels, motivational gamification, asynchronous chat function patient-health professionals, and a platform for remote monitoring by health professionals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Desirable feasibility level
Time Frame: Through study completion, an average of 3 months
Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility.
Through study completion, an average of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
App performance and functionality
Time Frame: Through study completion, an average of 3 months
Acceptable number of errors (≤5 errors per participant) in the performance and functionality experienced by the patients and project group members
Through study completion, an average of 3 months
Patient-reported software usability
Time Frame: At 3 months
Considered feasible if the System Usability Scale median score is ≥68 on a 0-100 scale, 100= best score
At 3 months
Patient and health professionals' training requirements
Time Frame: Pre-baseline for health professionals and at baseline for patients
Measured by registering amount of time spent (minutes) on training
Pre-baseline for health professionals and at baseline for patients
Integration of workflow for health professionals
Time Frame: At screening and enrollment
Measured by registering time spent on screening and enrollment
At screening and enrollment
Serum urate level
Time Frame: At 3 months
Considered feasible if there is available data on serum urate levels for ≥90% of patients for calculation of mean levels and proportion with low serum urate level
At 3 months
Patient-reported software functionality
Time Frame: Through study completion, an average of 3 months
Total number of reported errors related to the software functionality (e.g., downloading, login, registration of medication, reminders, access to videos, medication adherence, registration of blood test results, urate level graph, blood test history, chat, request new prescription). Considered acceptable feasibility if the number of errors are ≤5 per patient in the performance and functionality experienced by the patients and project group members.
Through study completion, an average of 3 months
Urate lowering therapy dose escalation
Time Frame: Through study completion, an average of 3 months
Considered feasible if patient-reported data and the medication history in the app monitored in the platform for health personnel is available for ≥90% of patients.
Through study completion, an average of 3 months
Patient-reported adherence to serum urate lowering therapy
Time Frame: At 3 months
Patient-reported Medication Adherence Report Scale (MARS-5), score range 5-25, higher scores mean better adherence. Considered acceptable feasibility if >=90% of the patients complete the instrument.
At 3 months
Acute gout flares
Time Frame: At 3 months
Number of acute gout flares
At 3 months
Side-effects of urate lowering therapy
Time Frame: At 3 months
Number of side-effects registered in the app or by study nurse or study coordinator
At 3 months
Adverse events
Time Frame: At 3 months
Number of adverse events (incl. serious adverse events) registered by study medical doctor, study nurse or study coordinator
At 3 months
Knowledge of gout and recommended treatment
Time Frame: At baseline and 3 months
Measured by the Gout Knowledge Questionnaire, 0-10, higher scores mean better outcome. Considered acceptable feasibility if there is available total score data for >=90% of the patients.
At baseline and 3 months
Pain related to gout
Time Frame: At 3 months
Measured by a numeric rating scale (NRS) 0-10, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.
At 3 months
Activity limitations
Time Frame: At 3 months
Measured by Work Productivity and Activity Impairment (WPAI) item no.6, 0-10, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.
At 3 months
Number of consultations in specialist or primary healthcare
Time Frame: At 3 months
Considered acceptable feasibility if there is available data for ≥90% of patients on patient-reported visits in specialist or primary healthcare
At 3 months
Costs and time for traveling
Time Frame: At 3 months
Considered acceptable feasibility if there is available data for ≥90% of patients on patient-reported time for travelling to the hospital
At 3 months
Sick leave and time off work
Time Frame: At 3 months
Considered acceptable feasibility if there is available data for ≥90% of participants using self-report
At 3 months
Eligible patients per month
Time Frame: At enrollment
Number of eligible patients per month.
At enrollment
Recruitment rate
Time Frame: After enrollment
Acceptable recruitment rate is ≥50% of eligible patients.
After enrollment
Patient dropout
Time Frame: At 3 months
Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.
At 3 months
Trial logistics
Time Frame: At 3 months
Acceptable overall trial logistics (Identification, screening, recruitment, patient training, data collections, monitoring blood test results, renewal of prescriptions) evaluated as Yes vs. No by the study group.
At 3 months
Patients' app use: videos watched
Time Frame: Through study completion, an average of 3 months
Count the number of videos watched per participant. Considered acceptable feasibility if ≥70% of the participants have watched at least 1 video.
Through study completion, an average of 3 months
Patients' app use: registrations of daily medication adherence
Time Frame: Through study completion, an average of 3 months
Count the number of registrations of daily medication adherence. Considered acceptable feasibility if ≥70% of the participants have registered at least 1 adherence.
Through study completion, an average of 3 months
Patients' app use: registration of serum urate levels
Time Frame: Through study completion, an average of 3 months
Count the number of registered serum urate levels. Considered acceptable feasibility if ≥90% of the patients register their serum urate level monthly.
Through study completion, an average of 3 months
Patients' app use: chat messages
Time Frame: Through study completion, an average of 3 months
Count the number of chat messages. Considered acceptable feasibility if ≥70% of the participants register at least 1 chat message.
Through study completion, an average of 3 months
Patients' app use: flare registering
Time Frame: Through study completion, an average of 3 months
Count the number of flare registering. Considered acceptable feasibility if ≥10% of the participants register 1 flare.
Through study completion, an average of 3 months
Potential risk and challenges
Time Frame: At 3 months
Incidence of hinders that could harm a successful clinical evaluation of the app in a large randomised, controlled trial.
At 3 months
Patient-reported experiences and perceived benefits with the app
Time Frame: At 3 months
Open responses will be collected in semi-structured interview. No scales or instruments will be used
At 3 months
Patient-reported satisfaction with the app
Time Frame: At 3 months
Measured by a numeric rating scale (NRS) 0-10, higher scores mean better outcome. Acceptable feasibility if >=70% of the participants report score >=5, otherwise considered not acceptable feasibility.
At 3 months
Health related quality of life
Time Frame: At 3 months
Measured by the Euro Quality of Life 5 Dimensions 5 Levels, each item is scored 1-5, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.
At 3 months
Patient satisfaction with the follow-up care
Time Frame: At 3 months
Measured by a single item with 5 response categories, ranging from very dissatisfied to very satisfied, higher scores mean higher satisfaction. Considered acceptable feasibility if >=70% of the participants report to be satisfied or very satisfied.
At 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diakonhjemmet Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nina Østerås, Prof., Diakonhjemmet Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23/02662
  • 2023054 (Other Grant/Funding Number: South-Eastern Norway Health Authority)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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