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Rheumatoid ArthritisNCT04536844

Telehealth Follow-up in Patients With Rheumatoid Arthritis

A study testing Mobile application MyDignio (follow disease activity by assigning questionnaires to participants) and Conventional prescheduled follow-up in people with Rheumatoid Arthritis and Treatment Compliance, run by Vestre Viken Hospital Trust at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis, Treatment Compliance
What is being tested?
Mobile application MyDignio (follow disease activity by assigning questionnaires to participants) and Conventional prescheduled follow-up
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteNorway
Study dates
15 Jun 2020to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >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

Who cannot join

  • <18 years
  • Severe cognitive failure

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Martina Hansens Hospital

    Sandvika, Akershus, 1337

Other trials in Norway

About this study

Official title: 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

Read the 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.

Being tested
Mobile application MyDignio (follow disease activity by assigning questionnaires to participants), Conventional prescheduled follow-up
Medical subject headings
Arthritis, Rheumatoid, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Conventional prescheduled follow-upOther

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

Study groups in NCT04536844
Study groupRoleWhat they receive
Telehealth follow-up groupExperimentalRheumatoid arthritis patients in remission who will be followed by an electronic app
Receives: Device: Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)
Conventional follow-up groupPlacebo comparatorRheumatoid arthritis patients in remission who will attend conventional prescheduled visits in the outpatient clinic
Receives: Other: Conventional prescheduled follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 52 weeks

Secondary outcomes (2)

  1. Satisfaction rates

    Compare satisfaction rates (as measured by Visual analog scale (VAS) satisfaction with the follow-up procedures) among the 2 patient groups

    Measured: 52 weeks

  2. Clinical disease activity index (CDAI)

    CDAI for both groups at baseline and at 52 weeks

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2020
  2. Study start15 Jun 2020
  3. Primary completion15 Aug 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04536844
Sponsor's protocol ID
33172
Status last verified
Oct 2020
First submitted
17 Nov 2019
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24550173

  • 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.

    PubMed 26290587

  • 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.

    PubMed 26290061

  • 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.

    PubMed 28716313

  • 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.

    PubMed 28511288

  • 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.

    PubMed 27933206

  • 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.

    PubMed 17083765

Questions about this trial

What is this clinical trial studying?

A study testing Mobile application MyDignio (follow disease activity by assigning questionnaires to participants) and Conventional prescheduled follow-up in people with Rheumatoid Arthritis and Treatment Compliance, run by Vestre Viken Hospital Trust at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients suffering a flare (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04536844, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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