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CompletedNCT03773471Updated Jun 22, 2023

A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making

An interventional study of Mobile Health App in Rheumatoid Arthritis, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The overall goal is to improve shared decision-making (SDM) about treatment options and thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with rheumatoid arthritis (RA). The objective of this study is to engage patients in using the ArthritisPower application on a weekly basis during the time between clinic appointments for collection of data on self-reported disease activity and patient-reported outcomes (PROs), and to display the data using an iPad to the patients and their rheumatology health care providers (HCPs) at the point of care for SDM.

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Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 69 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years.
  2. Fulfillment of the ACR/EULAR 2010 classification criteria for RA [9].
  3. Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit.
  4. Intent to modify DMARD therapy (i.e., adding a DMARD, switching to a new DMARD, or changing DMARD dosage) by the patient and HCP.

Exclusion criteria

Exclusion criteria:

  1. Current or previous use of ArthritisPower™ by the patient.
  2. Lack of access to an ArthritisPower™ compatible device (e.g., smartphone, tablet, or computer)
  3. Inability or unwillingness to participate with using the ArthritisPower™ app for this study
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • No intervention
    Control Arm

    Standard of care

  • Experimental
    Intervention Arm

    Mobile Health App

    Behavioral: Mobile Health App

Interventions

  • BehavioralMobile Health App

    ArthritisPower App

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What researchers measure

Primary outcomes

  1. - Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1).

    Time frame: 24 months

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Study locations

2 sites
  • Michigan Medicine - Rheumatology
    Ann Arbor, Michigan 48109-5358, United States
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03773471
Lead sponsor
Mayo Clinic
Responsible party
John M. Davis, III (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Dec 12, 2018
Start date
Oct 20, 2020
Primary completion
Jun 21, 2023
Completion
Jun 21, 2023
Last update
Jun 22, 2023

Study contacts

John M Davis
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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