Telehealth-delivered HealthcaRe to ImproVe Care

NCT05483855 | Recruiting

• 1 other identifier: THRIVERTM
• Study Type: observational
• Target: 1,580
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Telemedicine

Outcome Measures

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).

  Immediately after the intervention

Study Arms (2)

Objective 1: Telehealth Visit

Any rheumatology patient, seen and treated by a participating physician, who is 19 years and older, with the target condition(s) of interest, and is already scheduled for a telehealth visit.

Other: Objective 1 Only: Telehealth Satisfaction Survey

Objective 2: ArthritisPower App

Patients diagnosed with Rheumatoid Arthritis who already have a pre-scheduled in-office visit.

Other: Objective 2 Only: ArthritisPower Joint Assessment

Interventions

Objective 1 Only: Telehealth Satisfaction Survey OTHER

Participants 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 1: Telehealth Visit

Objective 2 Only: ArthritisPower Joint Assessment OTHER

RA 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.

Objective 2: ArthritisPower App

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with Rheumatoid Arthritis seen in a Rheumatology Clinic.

You may qualify if:

• 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.

You may not qualify if:

• Younger than 19 years of age
• Does not have a prior diagnosis of Rheumatoid Arthritis.
• Unable to read and write in English or Spanish

Sponsors & Collaborators

• Attune Health Research, Inc.: lead
• Rheumatology Research Foundation: collaborator

Study Sites (1)

Attune Health Research Inc

Beverly Hills, California, 90211, United States

RECRUITING

Central Study Contacts

Natalie Fortune

CONTACT

3106520010; research.admin@attunehealth.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 2, 2022
• Study Start: January 3, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)