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Reducing Disparities in Medication Adherence in SLE

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ClinicalTrials.gov Identifier: NCT03738826
Recruitment Status : Not yet recruiting
First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Duke University

Brief Summary:
This is a pilot study to assess the feasibility of a multi-level intervention to improve medication adherence in patients with systemic lupus erythematosus

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Behavioral: Behavioral Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Intervention arm
A multilevel intervention targeted towards lupus clinic providers, staff, and patients to improve medication adherence in lupus patients will be tested to assess its feasibility and acceptability.
Behavioral: Behavioral Intervention
The intervention will be developed based on quantitative and qualitative data that is currently being collected. After data collection and analysis, an intervention will be designed with input from stake holders including lupus clinic providers, staff, and patients.




Primary Outcome Measures :
  1. Feasibility - number of patients able to complete the intervention [ Time Frame: over 12 weeks ]
    Feasibility as measured by number of patients able to complete the intervention

  2. Acceptability - number of participants that stated the intervention was easy to use [ Time Frame: over 12 weeks ]
    Acceptability as measured by number of participants that stated the intervention was easy to use.


Secondary Outcome Measures :
  1. Medication adherence [ Time Frame: over 12 weeks ]
    This will be determined by self report

  2. Medication refills [ Time Frame: over 12 weeks ]
    This will be determined by pharmacy refill data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English fluency
  • having SLE actively followed by treating rheumatologist for ≥6months
  • prescribed ≥1 scheduled, oral or injectable disease-modifying medication for SLE

Exclusion Criteria:

  • pregnant or nursing
  • seen for the first time
  • significant cognitive impairment as determined by treating rheumatologist, or otherwise unable to comply with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738826


Contacts
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Contact: Edna Scarlett 919 684 6150 edna.scarlett@duke.edu
Contact: Kai Sun kai.sun@duke.edu

Sponsors and Collaborators
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Kai Sun Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03738826     History of Changes
Other Study ID Numbers: Pro00100861
5U54MD012530-02 ( U.S. NIH Grant/Contract )
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
medication adherence
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases