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Telehealth Follow-up in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04536844
Recruitment Status : Active, not recruiting
First Posted : September 3, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
London School of Economics and Political Science
Helse Sor-Ost
Information provided by (Responsible Party):
Anne Bull Haaversen, Martina Hansen's Hospital

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Treatment Compliance Device: Mobile application MyDignio (follow disease activity by assigning questionnaires to participants) Other: Conventional prescheduled follow-up Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a pragmatic noninferiority randomized controlled trial (RCT) in Norwegian RA patients in clinical remission (based on RAPID3 score). The patients will be allocated to 2 groups. One group will be followed up by an electronic app, while the second group will attend conventional prescheduled visits in the outpatient clinic of Martina Hansens Hospital. A computer-generated random number sequence will be used for the randomization of the RA patients.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Telehealth Follow-up in Patients With Rheumatoid Arthritis. A Noninferiority Randomized Control Trial
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Clinical disease activity index (CDAI) [ Time Frame: 52 weeks ]
    CDAI for both groups at baseline and at 52 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536844


Locations
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Norway
Martina Hansens Hospital
Sandvika, Akershus, Norway, 1337
Sponsors and Collaborators
Martina Hansen's Hospital
London School of Economics and Political Science
Helse Sor-Ost
Investigators
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Principal Investigator: Andreas Diamantopoulos, MD, PhD, MPH Martina Hansens Hospital
  Study Documents (Full-Text)

Documents provided by Anne Bull Haaversen, Martina Hansen's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] March 26, 2020

More Information
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Publications:

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Responsible Party: Anne Bull Haaversen, Co-principal Investigator, Martina Hansen's Hospital
ClinicalTrials.gov Identifier: NCT04536844    
Other Study ID Numbers: 33172
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases