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

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

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.

Study Overview

• Status: Completed
• Conditions: Lupus
• Intervention / Treatment: Other: Decision-making tool; Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with validated lupus diagnosis on Hydroxychloroquine (HCQ)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with lupus	Other: 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.; Other: Questionnaire; Questionnaire to assess participant's understanding of the decision-making tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medication adherence	Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using the proportion of days covered (PDC). PDC is calculated using prescription refill data (PDC = Sum of days covered/number of days in the observation period)	Baseline to 3 months
Change in proportion of adherent participants	Compare the proportion of adherent patients (Adherence = PDC ≥ 80%) at baseline v 6 months after completing intervention	Baseline to 6 months
Change in medication adherence - participant reported	Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using participant self-report (adherence = 80% prescriptions refilled)	Baseline to 3 months
Change in medication adherence - blood levels	Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using blood levels (adherence = 500 ng/ml or higher)	Baseline to 3 months
Change in proportion of adherent participants - participant reported	Compare the proportion of adherent patients (Adherence = 80% prescription refills) at baseline v 6 months after completing intervention	Baseline to 6 months
Change in proportion of adherent participants - blood levels	Compare the proportion of adherent patients through blood levels (Adherence = 500 ng/ml or higher) at baseline v 6 months after completing intervention	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in decisional conflict scores	Decisional conflict scores range from 0 (best) to 1 (worst) with 0.25 as an indicator of residual decisional conflict.	Baseline to 6 months
Assess participant satisfaction with decision-making tool	Participant satisfaction using a Likert scale 0-7 (7=most satisfied)	Post-intervention, on average 6 months
Intervention completion	Total number of visits with participants completing the intervention during the study period	Duration of study, up to 12 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Shivani Garg, MD, MS, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: hydroxychloroquine
• Other Study ID Numbers: 2023-0846; Protocol Version 5/23/23 (Other Identifier: UW Madison); SMPH/MEDICINE/RHEUMATOL (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No