Medication Adherence in Rheumatic Diseases

Chronic Rheumatic Diseases Clinical Trial

Official title:

Improving Medication Adherence in Chronic Rheumatic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018350
• Other study ID #: Pro00108618
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: Kai Sun, MD, MS
• Phone: 919 681 7405
• Email: kai.sun[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will pilot test a clinician-led intervention to improve medication adherence in general rheumatology clinic across a spectrum of rheumatic diseases. The study will assess feasibility, acceptability, and fidelity, and explore signal for improved medication adherence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all providers at Southpoint Rheumatology All patients with a rheumatic disease diagnosis currently prescribed at least one rheumatic medication will be included in the analysis

Exclusion Criteria:

• new patients, those who are not prescribed any rheumatic disease medications, or do not have available pharmacy refill data

Related Conditions & MeSH terms

• Chronic Rheumatic Diseases
• Collagen Diseases
• Rheumatic Diseases

Intervention

Behavioral:
• Clinician-led adherence intervention
The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Feasibility	Percent of providers agreeing to participate	4 weeks
Primary	Intervention Feasibility	Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, 5 is most feasible	4 weeks
Primary	Intervention Feasibility	Percent of visits with EMR documentation of providers reviewing refills	4 weeks
Secondary	Acceptability	Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, 5 is most acceptable	4 weeks
Secondary	Acceptability, as measured by the percentage of patients who report a positive feeling after having an adherence conversation with their providers	Patient survey will be administered after their provider visit	4 weeks
Secondary	Fidelity	Provider survey about the frequency of conducting the intervention components of reviewing pharmacy refills and using effective communication strategies	4 weeks
Secondary	Fidelity	Frequency of EMR documentation of completing the intervention components of reviewing pharmacy refills and using effective communication strategies	4 weeks
Secondary	Change in medication adherence	90-day medication possession ratio at 3 months after the intervention visit compared to baseline	baseline, 3 months
Secondary	Change in medication adherence	90-day medication possession ratio at 6 months after the intervention visit compared to baseline	baseline, 6 months