Telehealth Follow-up in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis, Treatment Compliance
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)
Conventional prescheduled follow-up
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- >18 years
- Fulfilling the European League against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2010 classification criteria for RA
- Being in remission (RAPID 3 score <=3)
- Able to use the electronic app
- Able to give informed consent
Exclusion Criteria:
- <18 years
- Severe cognitive failure
Sites / Locations
- Martina Hansens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Telehealth follow-up group
Conventional follow-up group
Arm Description
Rheumatoid arthritis patients in remission who will be followed by an electronic app
Rheumatoid arthritis patients in remission who will attend conventional prescheduled visits in the outpatient clinic
Outcomes
Primary Outcome Measures
Number of patients suffering a flare
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
Satisfaction rates
Compare satisfaction rates (as measured by Visual analog scale (VAS) satisfaction with the follow-up procedures) among the 2 patient groups
Clinical disease activity index (CDAI)
CDAI for both groups at baseline and at 52 weeks
Full Information
NCT ID
NCT04536844
First Posted
November 17, 2019
Last Updated
October 21, 2020
Sponsor
Martina Hansen's Hospital
Collaborators
London School of Economics and Political Science, Helse Sor-Ost
1. Study Identification
Unique Protocol Identification Number
NCT04536844
Brief Title
Telehealth Follow-up in Patients With Rheumatoid Arthritis
Official Title
Telehealth Follow-up in Patients With Rheumatoid Arthritis. A Noninferiority Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martina Hansen's Hospital
Collaborators
London School of Economics and Political Science, Helse Sor-Ost
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Treatment Compliance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telehealth follow-up group
Arm Type
Experimental
Arm Description
Rheumatoid arthritis patients in remission who will be followed by an electronic app
Arm Title
Conventional follow-up group
Arm Type
Placebo Comparator
Arm Description
Rheumatoid arthritis patients in remission who will attend conventional prescheduled visits in the outpatient clinic
Intervention Type
Device
Intervention Name(s)
Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional prescheduled follow-up
Intervention Description
Patients will be followed in the outpatient clinic by prescheduled follow-up
Primary Outcome Measure Information:
Title
Number of patients suffering a flare
Description
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)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Satisfaction rates
Description
Compare satisfaction rates (as measured by Visual analog scale (VAS) satisfaction with the follow-up procedures) among the 2 patient groups
Time Frame
52 weeks
Title
Clinical disease activity index (CDAI)
Description
CDAI for both groups at baseline and at 52 weeks
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 years
Fulfilling the European League against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2010 classification criteria for RA
Being in remission (RAPID 3 score <=3)
Able to use the electronic app
Able to give informed consent
Exclusion Criteria:
<18 years
Severe cognitive failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Diamantopoulos, MD, PhD, MPH
Organizational Affiliation
Martina Hansens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martina Hansens Hospital
City
Sandvika
State/Province
Akershus
ZIP/Postal Code
1337
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24550173
Citation
Cross M, Smith E, Hoy D, Carmona L, Wolfe F, Vos T, Williams B, Gabriel S, Lassere M, Johns N, Buchbinder R, Woolf A, March L. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1316-22. doi: 10.1136/annrheumdis-2013-204627. Epub 2014 Feb 18.
Results Reference
background
PubMed Identifier
26290587
Citation
McBain H, Shipley M, Olaleye A, Moore S, Newman S. A patient-initiated DMARD self-monitoring service for people with rheumatoid or psoriatic arthritis on methotrexate: a randomised controlled trial. Ann Rheum Dis. 2016 Jul;75(7):1343-9. doi: 10.1136/annrheumdis-2015-207768. Epub 2015 Aug 19.
Results Reference
background
PubMed Identifier
26290061
Citation
Haugeberg G, Hansen IJ, Soldal DM, Sokka T. Ten years of change in clinical disease status and treatment in rheumatoid arthritis: results based on standardized monitoring of patients in an ordinary outpatient clinic in southern Norway. Arthritis Res Ther. 2015 Aug 20;17(1):219. doi: 10.1186/s13075-015-0716-0.
Results Reference
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PubMed Identifier
28716313
Citation
de Jong MJ, van der Meulen-de Jong AE, Romberg-Camps MJ, Becx MC, Maljaars JP, Cilissen M, van Bodegraven AA, Mahmmod N, Markus T, Hameeteman WM, Dijkstra G, Masclee AA, Boonen A, Winkens B, van Tubergen A, Jonkers DM, Pierik MJ. Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial. Lancet. 2017 Sep 2;390(10098):959-968. doi: 10.1016/S0140-6736(17)31327-2. Epub 2017 Jul 14.
Results Reference
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PubMed Identifier
28511288
Citation
de Thurah A, Stengaard-Pedersen K, Axelsen M, Fredberg U, Schougaard LMV, Hjollund NHI, Pfeiffer-Jensen M, Laurberg TB, Tarp U, Lomborg K, Maribo T. Tele-Health Followup Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Mar;70(3):353-360. doi: 10.1002/acr.23280. Epub 2018 Jan 23.
Results Reference
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PubMed Identifier
27933206
Citation
van Riel P, Alten R, Combe B, Abdulganieva D, Bousquet P, Courtenay M, Curiale C, Gomez-Centeno A, Haugeberg G, Leeb B, Puolakka K, Ravelli A, Rintelen B, Sarzi-Puttini P. Improving inflammatory arthritis management through tighter monitoring of patients and the use of innovative electronic tools. RMD Open. 2016 Nov 24;2(2):e000302. doi: 10.1136/rmdopen-2016-000302. eCollection 2016.
Results Reference
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PubMed Identifier
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Citation
Pincus T, Yazici Y, Bergman M, Swearingen C, Harrington T. A proposed approach to recognise "near-remission" quantitatively without formal joint counts or laboratory tests: a patient self-report questionnaire routine assessment of patient index data (RAPID) score as a guide to a "continuous quality improvement" s. Clin Exp Rheumatol. 2006 Nov-Dec;24(6 Suppl 43):S-60-5; quiz S-66-73.
Results Reference
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Telehealth Follow-up in Patients With Rheumatoid Arthritis
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