Back to resultsA Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health App
Sponsored by
About this trial
This is an interventional health services research trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Michigan Medicine - Rheumatology
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Arm
Intervention Arm
Arm Description
Standard of care
Mobile Health App
Outcomes
Primary Outcome Measures
- 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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03773471
Brief Title
A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
June 21, 2023 (Actual)
Study Completion Date
June 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Mobile Health App
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health App
Intervention Description
ArthritisPower App
Primary Outcome Measure Information:
Title
- 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Davis
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine - Rheumatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5358
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
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