Medication Adherence in Rheumatic Diseases

NCT06018350 | Completed Results

• 1 other identifier: Pro00108618
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Rheumatic Diseases

Outcome Measures

Primary Outcomes (3)

• Intervention Feasibility as Measured by Number of Providers Agreeing to Participate

  4 weeks

• Intervention Feasibility as Measured by the Feasibility of Intervention Measure (FIM)

  Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, where 5 is most feasible.

  4 weeks

• Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills

  Calculated for the full population, not per participant.

  4 weeks

Secondary Outcomes (5)

• Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM)

  4 weeks

• Intervention Acceptability as Measured by the Percentage of Patients Who Report a Positive Feeling After Having an Adherence Conversation With Their Providers

  4 weeks

• Fidelity as Measured by the Number of Participants With Clinicians Conducting the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies

  4 weeks

• Fidelity as Measured by the Number of Participants With EMR Documentation of Completing the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies

  4 weeks

• Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample

  Baseline to 3 months

Other Outcomes (1)

• Change in MPR (Medication Possession Ratio) as a Percentage

  Baseline to 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Clinicians in this arm will be trained to conduct the adherence intervention in general rheumatology clinic with all follow up patients with a chronic rheumatic disease. Patients seen by these clinicians will contribute to the outcome data collection.

Behavioral: Clinician-led adherence intervention

Interventions

Clinician-led adherence intervention BEHAVIORAL

The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Kai Sun, M.D.
• Organization: Duke University

kai.sun@duke.edu

919-681-7417

Study Officials

• Kai Sun, MD, MS

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: February 2, 2024
• Primary Completion: June 5, 2024
• Study Completion: June 22, 2024
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)