NCT05301621

Brief Summary

This is a proof-of-concept study. The main goal is to evaluate if the accelerometry signal recorded from patients with arthritis in different disease activity stages, allows for assessment of the activity status. It will also be analysed if the accelerometry signal can be classified as registered in arthritis patients vs. registered in healthy control. Arthritis subjects will be recruited from the outpatients' clinic of the Rheumatology Department Helse Førde, Førde, Norway. Healthy control subjects will be recruited from the same administrative area as the patients and will be invited to participate via announcement on the Helse Forde Medical Trust website. Four visits to the site are planned for the arthritis group and one for the control group. The patients will be recruited in the active phase of arthritis as defined in the inclusion criteria. The study's secondary objective is to develop methods for analysing the accelerometry signal in arthritis patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 12, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

March 19, 2022

Last Update Submit

August 15, 2022

Conditions

Arthritis, RheumatoidSpondyloarthritisPsoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Detection of arthritis activity status

    Analysis of raw akcelerometry will be used to detect disease activity status

    2023

Study Arms (2)

Arthritis patients

It is not planned any intervention. The patients' group will be invited to 4 visits.

Other: Akcelerometry follow up

Healthy controls

No intervention planned. Only one visit will be conducted.

Other: Akcelerometry follow up

Interventions

Akcelerometry follow upOTHER

The patients and control group will be followed up with single accelerometer.

Arthritis patientsHealthy controls

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be collected from Rheumatologic outpatients clinic Helse Forde. Only patients with the active disease will be included.

You may qualify if:

  • Patients:
  • Clinical diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SPA).
  • Planned or newly started (within 4 weeks before baseline visit) disease-modifying treatment.
  • Disis activity defined as:
  • RA - DAS28 (ESR or CRP) minimum 3.2,
  • PsA - DAPSA minimum 15,
  • SPA - BASDAI minimum 4.0.
  • A minimum number of tender or swollen joints:
  • RA - 4/4,
  • PsA - 2/2,
  • SPA - not applicable.

You may not qualify if:

  • Willing to participate and consent competent.
  • Over 18 years old.
  • Controls:
  • Without any inflammatory rheumatic disease
  • Willing to participate and consent competent.
  • Over 18 years old.
  • Both patients and controls:
  • Chronic neurologic disorders such as multiple sclerosis, parkinsonism, active epilepsy, symptomatic peripheral neuropathy, sequels after radiculopathy or other central nervous system deficit.
  • Paresis after cerebral stroke (mild deficits or TIA can be allowed).
  • Serious heart failure (NYHA 3 or above).
  • Pregnancy.
  • Active psychotic disorder.
  • Activ alcohol or drug addiction.
  • Fast use of medicine that can significantly influence CNS function (low dose sleeping medicine 12 hours before a visit can be allowed).
  • Spinal compression fractures less than six months before baseline.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pawel Mielnik

Førde, Vestlandet, 6812, Norway

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthritisArthritis, Psoriatic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone DiseasesSpondylarthropathiesPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Study Officials

  • Pawel Mielnik, MD, PhD

    Helse Forde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pawel Mielnik, MD, PhD

CONTACT

+ 4757839000post@helse-forde.no

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Rheumatology

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 31, 2022

Study Start

May 12, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)