Intervention to Improve Communication and Medication Adherence in Lupus

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06458075
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • CO-LEAD — BEHAVIORAL
    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 Details

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. 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. 2. 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.

Key Dates

Start date
Jul 1, 2024
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Control
    Control clinicians will continue usual care.
  • Active Comparator: CO-LEAD
    CO-LEAD clinicians will receive training in the intervention.

Primary Outcome Measure

Frequency of adherence discussions [ Time Frame: During intervention period (up to 2 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710

Find similar trials in Durham, NC

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Duke University· Durham, NC

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