Systemic Lupus ErythematosusCO-LEADNCT06458075
Intervention to Improve Communication and Medication Adherence in Lupus
A study testing CO-LEAD in people with Systemic Lupus Erythematosus, run by Duke University at 1 site in United States.
Trial summary
CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE). The purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- CO-LEAD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinician Inclusion Criteria:
- Adult rheumatology attendings, advanced practice providers, and fellows at the two academic institutions
- Clinicians who have ambulatory rheumatology care at least ½ day per week
Clinician Exclusion Criteria:
- Clinicians at Duke University who were involved in the investigators' pilot work
- Clinicians with an anticipated departure from the institution in the 12 months following enrollment
Patient Inclusion Criteria:
- 18 years or older
- English-speaking, able to provide consent
- Diagnosed with SLE and receiving care with enrolled clinicians
- Prescribed at least one SLE medication, and filling their SLE mediations at a pharmacy linked to Surescripts reporting visible in Epic EMR.
Patient Exclusion Criteria:
- Non-English speakers
- Patients who are prescribed only corticosteroids for SLE
- Patients who are accompanied by third-party member that is not willing or able to remain in the waiting room during the patient's visit and
- Does not wish to be audio recorded
- A minor without a parental/legal guardian and/or
- Unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Kai Sun, kai.sun@duke.edu
About this study
Official title: Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)
CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE).
The purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following:
- clinicians will be provided with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill date, engage and formulate solutions to adherence barriers, and collaboratively overcome adherence barriers.
- use of a reliable and valid patient-reported measure of the extent of and reasons for nonadherence that helps patients identify and communicate their adherence barriers with clinicians proactively, efficiently, and comprehensively.
Read the detailed description
Substantial racial disparities exist in patients with systemic lupus erythematosus (SLE), a disease that markedly reduces life expectancy and quality of life. Long-term, consistent use of immune-altering medicines is critical for treating symptoms and preventing organ damage from SLE, but Black patients have lower medication adherence. While reasons for nonadherence are complex, Black patients with SLE are disproportionately affected by motivational barriers related to their beliefs, attitudes, and trust. Effective and collaborative patient-clinician communication can lead to more honest exchange of information, strengthen trust and therapeutic alliance, and thereby increase medication adherence and improve health outcomes. Unfortunately, effective patient-clinician discussions about nonadherence occur sporadically, and Black patients experience worse communication with their clinicians. Existing adherence interventions in SLE do not address patient-clinician communication nor focus on reducing racial disparities.
In this study, clinicians will go through training on how to assess medication adherence and communicate more effectively with this population. Clinicians will familiarize with EMR pharmacy refill data and the DOSE-Nonadherence-SLE questionnaire, a validated measure of the extent of and reasons for nonadherence. Clinicians will practice having a medication nonadherence discussion with another clinician in the intervention arm and give each other feedback after the practice. Clinicians will also be provided with resource handouts for medication adherence. The training will increase clinicians' confidence in conducting the intervention, and gain empathy role-playing as the patient. CO-LEAD team members will observe and give feedback to clinicians in real time.
The study will assess both communication and adherence outcomes.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- CO-LEAD
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-LEADBehavioural
The investigators will provide clinicians with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill data and the DOSE-Nonadherence-SLE survey, and engage and formulate solutions to adherence barriers together. The study team will provide the clinician intervention training in-person or virtually and will include didactics, demonstration, and practice that include two one-hour sessions one month apart. After training, CO-LEAD clinicians will be encouraged to incorporate the intervention in regular clinic visits with all patients.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control clinicians will continue usual care. |
| CO-LEAD | Active comparator | CO-LEAD clinicians will receive training in the intervention. Receives: Behavioral: CO-LEAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adherence discussions
Proportion of SLE patient visits in which a nonjudgmental, patient-centered adherence discussion took place as determined by analysis of clinic visit audio recordings
Measured: During intervention period (up to 2 years)
Secondary outcomes (3)
Quality of patient-clinician communication determined by audio recordings
Audio recordings of clinic visits which will be analyzed using a validated coding scheme
Measured: During intervention period (up to 2 years)
Quality of patient-clinician communication determined by surveys
The Interpersonal Processes of Care survey will be used
Measured: During intervention period (up to 2 years)
Change in SLE medication adherence
Determined by pharmacy refill data. Proportion of days covered (PDC) will be calculated as total days of supply dispensed.
Measured: Baseline and post-intervention (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Kai Sun, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458075
- Sponsor's protocol ID
- Pro00115358
- Other IDs
- 1R01MD018977-01
- Acronym
- CO-LEAD
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- 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
- Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT06458075
- Acronym / sponsor ID
- CO-LEAD / Pro00115358
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE).
The purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following:
- clinicians will be provided with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill date, engage and formulate solutions to adherence barriers, and collaboratively overcome adherence barriers.
- use of a reliable and valid patient-reported measure of the extent of and reasons for nonadherence that helps patients identify and communicate their adherence barriers with clinicians proactively, efficiently, and comprehensively.
Detailed description
Substantial racial disparities exist in patients with systemic lupus erythematosus (SLE), a disease that markedly reduces life expectancy and quality of life. Long-term, consistent use of immune-altering medicines is critical for treating symptoms and preventing organ damage from SLE, but Black patients have lower medication adherence. While reasons for nonadherence are complex, Black patients with SLE are disproportionately affected by motivational barriers related to their beliefs, attitudes, and trust. Effective and collaborative patient-clinician communication can lead to more honest exchange of information, strengthen trust and therapeutic alliance, and thereby increase medication adherence and improve health outcomes. Unfortunately, effective patient-clinician discussions about nonadherence occur sporadically, and Black patients experience worse communication with their clinicians. Existing adherence interventions in SLE do not address patient-clinician communication nor focus on reducing racial disparities.
In this study, clinicians will go through training on how to assess medication adherence and communicate more effectively with this population. Clinicians will familiarize with EMR pharmacy refill data and the DOSE-Nonadherence-SLE questionnaire, a validated measure of the extent of and reasons for nonadherence. Clinicians will practice having a medication nonadherence discussion with another clinician in the intervention arm and give each other feedback after the practice. Clinicians will also be provided with resource handouts for medication adherence. The training will increase clinicians' confidence in conducting the intervention, and gain empathy role-playing as the patient. CO-LEAD team members will observe and give feedback to clinicians in real time.
The study will assess both communication and adherence outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control clinicians will continue usual care. |
| CO-LEAD | Active comparator | Behavioral: CO-LEADCO-LEAD clinicians will receive training in the intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CO-LEADThe investigators will provide clinicians with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill data and the DOSE-Nonadherence-SLE survey, and engage and formulate solutions to adherence barriers together. The study team will provide the clinician intervention training in-person or virtually and will include didactics, demonstration, and practice that include two one-hour sessions one month apart. After training, CO-LEAD clinicians will be encouraged to incorporate the intervention in regular clinic visits with all patients. | Behavioural | CO-LEAD |
Primary outcome
Frequency of adherence discussions
Time frame: During intervention period (up to 2 years)
Proportion of SLE patient visits in which a nonjudgmental, patient-centered adherence discussion took place as determined by analysis of clinic visit audio recordings
3 secondary outcomes
Quality of patient-clinician communication determined by audio recordings
Time frame: During intervention period (up to 2 years)
Quality of patient-clinician communication determined by surveys
Time frame: During intervention period (up to 2 years)
Change in SLE medication adherence
Time frame: Baseline and post-intervention (up to 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- 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.
Kai Sun, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-LEAD in people with Systemic Lupus Erythematosus, 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?
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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Sun, MD (919- 681- 7417, kai.sun@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adherence discussions (time frame: During intervention period (up to 2 years)). 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.