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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773471
• Other study ID #: 17-005947
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: June 21, 2023

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Mobile Health App
ArthritisPower App

Locations

Country	Name	City	State
United States	Michigan Medicine - Rheumatology	Ann Arbor	Michigan
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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).		24 months

External Links

•   Mayo Clinic Clinical Trials