Telehealth-delivered HealthcaRe to ImproVe Care
ConditionTelemedicine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorAttune Health Research, Inc.
About this trial
Objective 1:
Evaluate patients' satisfaction with their telehealth care and determine factors associated with satisfaction.
Objective 2:
Deploy PROs and patient self-assessment tools, specifically a patient-facing instructional in-app tool that instructs RA patients how to perform self-assessment examinations to observe and report the number of tender and swollen joint counts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be 19 years or older.
Must have a prior diagnosis of Rheumatoid Arthritis.
Must be able to read and write in English or Spanish.
Disqualifiers
Younger than 19 years of age
Does not have a prior diagnosis of Rheumatoid Arthritis.
Unable to read and write in English or Spanish
Trial population
Adults with Rheumatoid Arthritis seen in a Rheumatology Clinic.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Objective 1 Only: Telehealth Satisfaction Survey
Other interventionParticipants must complete a telehealth satisfaction survey rating their standard of care telehealth visit on a scale of 1 to 10, with 1 denoting low satisfaction and 10 denoting high satisfaction.
Objective 2 Only: ArthritisPower Joint Assessment
Other interventionRA patients must complete a self-assessment examination of their joints using the ArthritisPower app prior to their in-office visit, where a repeat joint assessment is performed by participating physician.
Treatment groups
1,580 Participants
are divided into 2 treatment groupsGroup A: Objective 1: Telehealth Visit1 intervention
Group B: Objective 2: ArthritisPower App1 intervention
Trial outcomes
Primary outcomes
1
Correlation between patient joint count and provider joint count
The investigators will examine and compare the patient and rheumatology provider's tender and swollen joint count summed scores and Pearson and Spearman's correlation coefficient (if the data is non-normally distributed). The investigators will also calculate a typical Clinical Disease Index (CDAI) for RA which is a composite score of TJC28 + SJC28 + Patient Global + Provider Global and correlate with the patient \[p\] CDAI (\[p\]TJC28 + \[p\]SJC28 + Patient Global + Provider Global). Disease remission for RA is denoted by a CDAI composite score of less than or equal to 2.8 while high RA disease activity is denoted by a CDAI score of 22 or greater. The investigators will also compute weighted kappa statistics, comparing the 4x4 table of remission, low moderate, and high disease activity categories, using the traditional CDAI cut points (2.8, 10, and 22).
Time frame
Immediately after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Attune Health Research, Inc.
Lead sponsor
Rheumatology Research Foundation
Collaborator
Source ClinicalTrials.gov