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Can better talks boost lupus med adherence? new study aims to find out.

NCT ID NCT06458075

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests a program called CO-LEAD that trains doctors to use effective communication strategies and a patient survey to identify barriers to taking lupus medications. Researchers will enroll 480 patients and their clinicians at two academic centers. The goal is to see if this approach increases medication adherence and improves patient-clinician communication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (communication training for clinicians and patient survey tool)
What this could lead to
If successful, this could improve how doctors and lupus patients discuss medications, leading to better adherence and disease control.
What could go wrong
This is a behavioral study, not a drug trial, so benefits may be modest. Results depend on clinician and patient engagement, and may not apply to all settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Clinician Inclusion Criteria: 1. Adult rheumatology attendings, advanced practice providers, and fellows at the two academic institutions 2. Clinicians who have ambulatory rheumatology care at least ½ day per week Clinician Exclusion Criteria: 1. Clinicians at Duke University who were involved in the investigators' pilot work 2. Clinicians with an anticipated departure from the institution in the 12 months following enrollment Patient Inclusion Criteria: 1. 18 years or older 2. English-speaking, able to provide consent 3. Diagnosed with SLE and receiving care with enrolled clinicians 4. 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: 1. Non-English speakers 2. Patients who are prescribed only corticosteroids for SLE 3. 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

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

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