Chronic Rheumatic DiseasesNCT06018350
Medication Adherence in Rheumatic Diseases
A study testing Clinician-led adherence intervention in people with Chronic Rheumatic Diseases, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rheumatic Diseases
- What is being tested?
- Clinician-led adherence intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 22 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- new patients, those who are not prescribed any rheumatic disease medications, or do not have available pharmacy refill data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Medication Adherence in Chronic Rheumatic Diseases
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
- Being tested
- Clinician-led adherence intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician-led adherence interventionBehavioural
The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Clinician-led adherence intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility as Measured by Number of Providers Agreeing to Participate
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (5)
Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, where 5 is most acceptable.
Measured: 4 weeks
Intervention 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 following provider visit.
Measured: 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
This was collected using a EMR Smartphrase where clinicians documented whether they reviewed pharmacy refill data or discussed adherence with patients.
Measured: 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
Measured: 4 weeks
Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start2 Feb 2024
- Primary completion5 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Sun, MD, MS, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018350
- Sponsor's protocol ID
- Pro00108618
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2023
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence in Chronic Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT06018350
- Acronym / sponsor ID
- Pro00108618
- Conditions
- Chronic Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Clinician-led adherence interventionClinicians 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- new patients, those who are not prescribed any rheumatic disease medications, or do not have available pharmacy refill data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician-led adherence interventionThe clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient | Behavioural | Intervention |
Primary outcome
Intervention Feasibility as Measured by Number of Providers Agreeing to Participate
Time frame: 4 weeks
Intervention Feasibility as Measured by the Feasibility of Intervention Measure (FIM)
Time frame: 4 weeks
Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, where 5 is most feasible.
Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills
Time frame: 4 weeks
Calculated for the full population, not per participant.
5 secondary outcomes
Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
Time frame: 4 weeks
Intervention Acceptability as Measured by the Percentage of Patients Who Report a Positive Feeling After Having an Adherence Conversation With Their Providers
Time frame: 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
Time frame: 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
Time frame: 4 weeks
Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample
Time frame: Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Sun, MD, MS principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician-led adherence intervention in people with Chronic Rheumatic Diseases, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility as Measured by Number of Providers Agreeing to Participate (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.