Clinical trial NCT05922722: Clarifying Misbeliefs About Hydroxychloroquine: Developing a Decision Aid for Patients With Lupus
Official title: Clarifying Misbeliefs About Hydroxychloroquine (HCQ): Developing an Individualized Decision Aid for Diverse Patients With Lupus (HCQ-IDEAL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus
Keywords: hydroxychloroquine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with validated lupus diagnosis on Hydroxychloroquine (HCQ)

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in medication adherence
timeFrame: Baseline to 3 months
measure: Change in medication adherence - participant reported
timeFrame: Baseline to 3 months
measure: Change in medication adherence - blood levels
timeFrame: Baseline to 3 months
measure: Change in proportion of adherent participants
timeFrame: Baseline to 6 months
measure: Change in proportion of adherent participants - participant reported
timeFrame: Baseline to 6 months
measure: Change in proportion of adherent participants - blood levels
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in decisional conflict scores
timeFrame: Baseline to 6 months
measure: Assess participant satisfaction with decision-making tool
timeFrame: Post-intervention, on average 6 months
measure: Intervention completion
timeFrame: Duration of study, up to 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Shivani Garg, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: