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

NCT ID: NCT03773471

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2023-06-21

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control Arm

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

Mobile Health App

Group Type EXPERIMENTAL

Mobile Health App

Intervention Type BEHAVIORAL

ArthritisPower App

Interventions

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Mobile Health App

ArthritisPower App

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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John M. Davis, III

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John M Davis

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Michigan Medicine - Rheumatology

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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17-005947

Identifier Type: -

Identifier Source: org_study_id

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