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NCT Number: NCT03773471

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

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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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Medicine - Rheumatology, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Fulfillment of the ACR/EULAR 2010 classification criteria for RA [9].
  • Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit.
  • 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

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

Treatment and study plan

mobile health app

Behavioral

ArthritisPower App

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2018
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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