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Clarifying Misbeliefs About Hydroxychloroquine: Developing a Decision Aid for Patients With Lupus (HCQ-IDEAL)

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Lupus

Treatments

Other: Questionnaire
Other: Decision-making tool

Study type

Observational

Funder types

Other

Identifiers

NCT05922722
SMPH/MEDICINE/RHEUMATOL (Other Identifier)
Protocol Version 5/23/23 (Other Identifier)
2023-0846

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Participants with lupus
Treatment:
Other: Decision-making tool
Other: Questionnaire

Trial contacts and locations

1

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Central trial contact

Shivani Garg, MD, MS

Data sourced from clinicaltrials.gov

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