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

Mayo Clinic

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Behavioral: Mobile Health App

Study type: Interventional

Funder types: Other

Identifiers

NCT03773471

17-005947

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Standard of care

Intervention Arm

Experimental group

Description:

Mobile Health App

Treatment:

Behavioral: Mobile Health App