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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03773471
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

John M Davis
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

No Intervention: Control Arm

Standard of care

Experimental: Intervention Arm

Mobile Health App

Interventions

Behavioral: - Mobile Health App

ArthritisPower App

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Michigan Medicine - Rheumatology, Ann Arbor, Michigan

Status

Recruiting

Address

Michigan Medicine - Rheumatology

Ann Arbor, Michigan, 48109-5358

Site Contact

Vivek Nagaraja, MBBS

[email protected]

888-229-3065

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

John M Davis, III, MD, MS

[email protected]

507-284-4277

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221

Site Contact

Alexa Meara, MD

[email protected]

614-293-4837