A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
A Multi-Center Cluster Randomized Controlled Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
1 other identifier
interventional
69
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
Started Oct 2020
Typical duration for not_applicable rheumatoid-arthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2023
CompletedJune 22, 2023
June 1, 2023
2.7 years
December 10, 2018
June 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
- 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
Study Arms (2)
Control Arm
NO INTERVENTIONStandard of care
Intervention Arm
EXPERIMENTALMobile Health App
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Michigan Medicine - Rheumatology
Ann Arbor, Michigan, 48109-5358, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John M Davis
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 10, 2018
First Posted
December 12, 2018
Study Start
October 20, 2020
Primary Completion
June 21, 2023
Study Completion
June 21, 2023
Last Updated
June 22, 2023
Record last verified: 2023-06