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

NCT05922722 | Completed

• 3 other identifiers: 2023-0846Protocol Version 5/23/23SMPH/MEDICINE/RHEUMATOL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus

Keywords

hydroxychloroquine

Outcome Measures

Primary Outcomes (6)

• 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 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

  Compare the proportion of adherent patients (Adherence = PDC ≥ 80%) at baseline v 6 months after completing intervention

  Baseline to 6 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 Outcomes (3)

• Change in decisional conflict scores

  Baseline to 6 months

• Assess participant satisfaction with decision-making tool

  Post-intervention, on average 6 months

• Intervention completion

  Duration of study, up to 12 months

Study Arms (1)

Participants with lupus

Other: Decision-making tool; Other: Questionnaire

Interventions

Decision-making tool 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.

Participants with lupus

Questionnaire OTHER

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

Participants with lupus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with validated lupus diagnosis on Hydroxychloroquine (HCQ)

You may qualify if:

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

You may not qualify if:

• participants with other autoimmune diseases
• participants who are not taking HCQ

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Shivani Garg, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: February 15, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)