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Completed

NCT Number: NCT05922722

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

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.

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Key information

Conditions

Lupus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Questionnaire

Other

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

Primary outcomes

  1. Change in medication adherence

    Time frame: Baseline to 3 months

    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)

  2. Change in medication adherence - participant reported

    Time frame: Baseline to 3 months

    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)

  3. Change in medication adherence - blood levels

    Time frame: Baseline to 3 months

    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)

  4. Change in proportion of adherent participants

    Time frame: Baseline to 6 months

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

  5. Change in proportion of adherent participants - participant reported

    Time frame: Baseline to 6 months

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

  6. Change in proportion of adherent participants - blood levels

    Time frame: Baseline to 6 months

    Compare the proportion of adherent patients through blood levels (Adherence = 500 ng/ml or higher) at baseline v 6 months after completing intervention

Secondary outcomes

  1. Change in decisional conflict scores

    Time frame: Baseline to 6 months

    Decisional conflict scores range from 0 (best) to 1 (worst) with 0.25 as an indicator of residual decisional conflict.

  2. Assess participant satisfaction with decision-making tool

    Time frame: Post-intervention, on average 6 months

    Participant satisfaction using a Likert scale 0-7 (7=most satisfied)

  3. Intervention completion

    Time frame: Duration of study, up to 12 months

    Total number of visits with participants completing the intervention during the study period

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Acronym: HCQ-IDEAL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2023
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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