Telehealth Follow-up in Patients With Rheumatoid Arthritis

NCT04536844 | Unknown

• 1 other identifier: 33172
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis; Treatment Compliance

Outcome Measures

Primary Outcomes (1)

• 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)

  52 weeks

Secondary Outcomes (2)

• Satisfaction rates

  52 weeks

• Clinical disease activity index (CDAI)

  52 weeks

Study Arms (2)

Telehealth follow-up group

EXPERIMENTAL

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)

Conventional follow-up group

PLACEBO COMPARATOR

Rheumatoid arthritis patients in remission who will attend conventional prescheduled visits in the outpatient clinic

Other: Conventional prescheduled follow-up

Interventions

Mobile application MyDignio (follow disease activity by assigning questionnaires to participants) DEVICE

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.

Telehealth follow-up group

Conventional prescheduled follow-up OTHER

Patients will be followed in the outpatient clinic by prescheduled follow-up

Conventional follow-up group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• \<18 years
• Severe cognitive failure

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• London School of Economics and Political Science: collaborator
• Helse Sor-Ost: collaborator

Study Sites (1)

Martina Hansens Hospital

Sandvika, Akershus, 1337, Norway

Location

Related Publications (7)

• 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.

  PMID: 24550173 BACKGROUND

• 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.

  PMID: 26290587 BACKGROUND

• 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.

  PMID: 26290061 BACKGROUND

• 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.

  PMID: 28716313 BACKGROUND

• 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.

  PMID: 28511288 BACKGROUND

• 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.

  PMID: 27933206 BACKGROUND

• 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.

  PMID: 17083765 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Patient Compliance

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Andreas Diamantopoulos, MD, PhD, MPH

  Martina Hansens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: September 3, 2020
• Study Start: June 15, 2020
• Primary Completion: August 15, 2021
• Study Completion: December 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

NO (1)