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

Lupus Clinical Trial

— HCQ-IDEAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922722
• Other study ID #: 2023-0846
• Secondary ID: Protocol Version
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Shivani Garg, MD, MS
• Phone: 608-263-2222
• Email: sgarg[@]medicine.wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Assess participant satisfaction with decision-making tool	Participant satisfaction using a Likert scale 0-7 (7=most satisfied)	Post-intervention, on average 6 months
Secondary	Intervention completion	Total number of visits with participants completing the intervention during the study period	Duration of study, up to 12 months