Telehealth Follow-up in Patients With Rheumatoid Arthritis

October 21, 2020 updated by: Anne Bull Haaversen, Martina Hansen's Hospital

Telehealth Follow-up in Patients With Rheumatoid Arthritis. A Noninferiority Randomized Control Trial

The main objective of the present project is to test the effect of a customized Patient-Reported-Outcome (PRO)-based telehealth follow-up compared to a conventional pre-scheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in patients with RA

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid arthritis (RA) is a chronic inflammatory joint disease with a high burden both for the patient and society. Outcomes for the individuals living with RA have been improved and the majority of RA patients are now in remission or low disease activity status. RA patients continue to be followed up by pre-scheduled visits, which may compromise accessibility for the sickest and thus, quality of care. The introduction of patient-initiated follow-up leads to a reduction in the use of outpatient clinic services without compromising outcomes. Self-monitoring and remote patient monitoring are facilitated by electronic innovative health tools. Among RA patients with low disease activity or remission, a Patient-Reported Outcome-based telehealth follow-up for tight control of disease activity in RA can achieve similar disease control as conventional outpatient follow-up and is likely to reduce the costs. Thus, the main objective of the present project is to test the effect of a customized PRO-based telehealth follow-up compared to a conventional prescheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in Norwegian RA patients.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • 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 Locations

  • Norway
    • Akershus
      • Sandvika, Akershus, Norway, 1337
        • Martina Hansens 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. >18 years
  2. Fulfilling the European League against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2010 classification criteria for RA
  3. Being in remission (RAPID 3 score <=3)
  4. Able to use the electronic app
  5. Able to give informed consent

Exclusion Criteria:

  1. <18 years
  2. Severe cognitive failure

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telehealth follow-up group
Rheumatoid arthritis patients in remission who will be followed by an electronic app
Device: Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)
An electronic application available both on Apple store and Android play which the patients can download for free will be used to collect data from the Telehealth follow up group. This group will be compared to conventional outpatient clinic follow-up group.
Placebo Comparator: Conventional follow-up group
Rheumatoid arthritis patients in remission who will attend conventional prescheduled visits in the outpatient clinic
Other: Conventional prescheduled follow-up
Patients will be followed in the outpatient clinic by prescheduled follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients suffering a flare
Time Frame: 52 weeks
comparison of the number of patients suffering a flare in each group (Flare is defined as a routine assessment of patient index data 3 (RAPID3) score >=3)
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction rates
Time Frame: 52 weeks
Compare satisfaction rates (as measured by Visual analog scale (VAS) satisfaction with the follow-up procedures) among the 2 patient groups
52 weeks
Clinical disease activity index (CDAI)
Time Frame: 52 weeks
CDAI for both groups at baseline and at 52 weeks
52 weeks

Collaborators and Investigators

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

Sponsor

Martina Hansen's Hospital

Collaborators

Helse Sor-Ost
London School of Economics and Political Science

Investigators

  • Principal Investigator: Andreas Diamantopoulos, MD, PhD, MPH, Martina Hansens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 15, 2020

Primary Completion (Anticipated)

August 15, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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