Trial Outcomes & Findings for Medication Adherence in Rheumatic Diseases (NCT NCT06018350)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Clinician-led Adherence Intervention - Clinicians 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. 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	Clinician-led Adherence Intervention - Patients Patients seen by these clinicians will contribute to the outcome data collection. 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
Overall Study STARTED	6	96
Overall Study COMPLETED	6	96
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data not collected on clinicians.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinician-led Adherence Intervention - Clinicians n=6 Participants 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. 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	Clinician-led Adherence Intervention - Patients n=96 Participants Patients seen by these clinicians will contribute to the outcome data collection. 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	Total n=102 Participants Total of all reporting groups
Age, Continuous	—	54 years STANDARD_DEVIATION 17 • n=96 Participants • Data not collected on clinicians.	54 years STANDARD_DEVIATION 17 • n=96 Participants • Data not collected on clinicians.
Sex: Female, Male Female	2 Participants n=6 Participants	81 Participants n=96 Participants	83 Participants n=102 Participants
Sex: Female, Male Male	4 Participants n=6 Participants	15 Participants n=96 Participants	19 Participants n=102 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6 Participants	5 Participants n=96 Participants	5 Participants n=102 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=6 Participants	91 Participants n=96 Participants	97 Participants n=102 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=96 Participants	0 Participants n=102 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	1 Participants n=96 Participants	1 Participants n=102 Participants
Race (NIH/OMB) Asian	1 Participants n=6 Participants	1 Participants n=96 Participants	2 Participants n=102 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=96 Participants	0 Participants n=102 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	31 Participants n=96 Participants	31 Participants n=102 Participants
Race (NIH/OMB) White	5 Participants n=6 Participants	57 Participants n=96 Participants	62 Participants n=102 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=96 Participants	0 Participants n=102 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	6 Participants n=96 Participants	6 Participants n=102 Participants
Region of Enrollment United States	6 Participants n=6 Participants	96 Participants n=96 Participants	102 Participants n=102 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Clinicians approached for study participation.

Outcome measures

Outcome measures
Measure	Clinician-led Adherence Intervention - Clinicians n=6 Participants 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. 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
Intervention Feasibility as Measured by Number of Providers Agreeing to Participate	6 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Data not collected on patients.

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

Outcome measures

Outcome measures
Measure	Clinician-led Adherence Intervention - Clinicians n=6 Participants 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. 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
Intervention Feasibility as Measured by the Feasibility of Intervention Measure (FIM)	4.60 score on a scale Standard Deviation 0.58

PRIMARY outcome

Timeframe: 4 weeks

Calculated for the full population, not per participant.

Outcome measures

Outcome measures
Measure	Clinician-led Adherence Intervention - Clinicians n=96 Visits 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. 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
Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills	65.0 percentage of visits

SECONDARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome measures
Measure	Clinician-led Adherence Intervention - Clinicians n=6 Participants 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. 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
Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM)	4.30 score on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: 4 weeks

Population: Patients who completed the survey.

Patient survey will be administered following provider visit.

Outcome measures

Outcome measures
Measure	Clinician-led Adherence Intervention - Clinicians n=42 Participants 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. 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
Intervention Acceptability as Measured by the Percentage of Patients Who Report a Positive Feeling After Having an Adherence Conversation With Their Providers	90.0 percentage of patients

SECONDARY outcome

Timeframe: 4 weeks

This was collected using a EMR Smartphrase where clinicians documented whether they reviewed pharmacy refill data or discussed adherence with patients.

Outcome measures

Outcome measures
Measure	Clinician-led Adherence Intervention - Clinicians n=96 Participants 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. 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
Fidelity as Measured by the Number of Participants With Clinicians Conducting the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies	62 Participants

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Clinician-led Adherence Intervention - Clinicians n=96 Participants 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. 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
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	62 Participants

SECONDARY outcome

Timeframe: Baseline to 3 months

MPR is calculated by dividing the number of days all patients were covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change for the entire sample.

Outcome measures

Outcome measures
Measure	Clinician-led Adherence Intervention - Clinicians n=96 Participants 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. 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
Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample	11.0 percentage of change

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

MPR is calculated by dividing the number of days a patient is covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change.

Outcome measures

Outcome data not reported

Adverse Events

Clinician-led Adherence Intervention - Clinicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinician-led Adherence Intervention - Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kai Sun, M.D.

Duke University

Phone: 919-681-7417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place