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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773471
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
John M. Davis, III, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Mobile Health App Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : July 6, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Arm
Standard of care
Experimental: Intervention Arm
Mobile Health App
Behavioral: Mobile Health App
ArthritisPower App




Primary Outcome Measures :
  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). [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773471


Locations
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United States, Michigan
Michigan Medicine - Rheumatology Recruiting
Ann Arbor, Michigan, United States, 48109-5358
Contact: Vivek Nagaraja, MBBS    888-229-3065    nagarajv@med.umich.edu   
Principal Investigator: Vivek Nagaraja, MBBS         
Sub-Investigator: Puja Khanna, MD, MPH         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: John M Davis, III, MD, MS    507-284-4277    davis.john4@mayo.edu   
Contact: Kathleen McCarthy-Fruin    507-284-4797    mccarthy1.kathleen@mayo.edu   
Principal Investigator: John M Davis, III, MD, MS         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Alexa Meara, MD    614-293-4837    Alexa.meara@osumc.edu   
Principal Investigator: Alexa Meara, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: John M Davis Mayo Clinic
Additional Information:
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Responsible Party: John M. Davis, III, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03773471    
Other Study ID Numbers: 17-005947
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases