Clarifying Misbeliefs About Hydroxychloroquine: Developing a Decision Aid for Patients With Lupus

NCT ID: NCT05922722

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-02-20

Brief Summary

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The purpose of this research study is to collect information from lupus patients about their experience with a tool that informs patients about the benefits vs. harms of a medication such as hydroxychloroquine. The main question it aims to answer is whether the decision-making tool will increase medication adherence.

Participants will be asked to complete questionnaires that assess their understanding of the decision-making tool.

Detailed Description

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This study will be no different from a routine lupus or lupus nephritis clinic visit. During the same visit that a participant routinely does for lupus with their healthcare team, a healthcare team member will discuss the tool that elaborates the benefits vs. risks of lupus medications such as hydroxychloroquine. Participants will complete questionnaires that assesses their understanding of the medication (hydroxychloroquine) before and after they complete the discussion regarding the medication using the tool with the healthcare team member.

Study team members will study the data collected to answer research questions. They will analyze the data and plan better steps improve care quality in lupus.

Conditions

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Lupus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with lupus

Decision-making tool

Intervention Type OTHER

The shared decision-making tool is a paper tool or an electronic version which will be available in the clinics for clinic team's use.

Questionnaire

Intervention Type OTHER

Questionnaire to assess participant's understanding of the decision-making tool

Interventions

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Decision-making tool

The shared decision-making tool is a paper tool or an electronic version which will be available in the clinics for clinic team's use.

Intervention Type OTHER

Questionnaire

Questionnaire to assess participant's understanding of the decision-making tool

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* validated SLE diagnosis
* no absolute contraindication to HCQ (e.g., retinopathy)
* prior HCQ therapy for at least 3-6 months

Exclusion Criteria

* participants with other autoimmune diseases
* participants who are not taking HCQ
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shivani Garg, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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Protocol Version 5/23/23

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/RHEUMATOL

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0846

Identifier Type: -

Identifier Source: org_study_id

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