BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease

Feasibility of BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease: The BIO-FACTS Pilot Study

Feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease

Study Overview

• Status: Recruiting
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Diagnostic test: blood and urine samples

Detailed Description

Background:

Statin therapy is known to improve clinical outcomes in patients with coronary artery disease (CAD), while being highly cost-effective. However, adherence to statin therapy in real world settings is suboptimal and represents a possible target to ameliorate secondary CAD disease prevention. Previous interventional studies on statin adherence showed inconsistent results and it is widely acknowledged that a tailored adherence improvement approach adapted to patient determinants is required. However, methodology to accurately detect and characterize non-adherent patients is challenging and constitutes an important obstacle to developing such interventions. Urine analysis with liquid chromatography/mass spectrometry (LC-MS) for detection of statin intake is a promising method for objective measurement of adherence as an adjunct to subjective adherence assessment using questionnaires, which has not been applied in CAD patients in Germany.

Objectives: In this pilot study (i) a feasibility testing of objective (LC-MS urine analysis) and subjective (questionnaire survey) measures of adherence to statin therapy will be performed, (ii) the prevalence of nonadherence in the target population will be determined , and (iii) instruments assessing possible factors associated with (non-)adherence (e.g. side effects, beliefs about medications, and disease-related knowledge) will be evaulated, in order to establish a methodological ground for further studies characterizing non-adherent patients.

Methods:

Outpatients with CAD treated in University Hospital Düsseldorf and receiving guideline-recommended atorvastatin or rosuvastatin on prescription will be included in the pilot study. Based on sample size calculation about 130 patients will be recruited. A biochemical method of objective urine measurement of statin intake by LC-MS will be combined with a preselected set of questionnaires on adherence behavior and associated factors. Clinical characteristics will be obtained from patient records. A sub-sample of the study population will be invited to participate in the interview for the evaluation of the questionnaire survey.

Outlook:

Based on the results of the pilot study, an adequately powered study to characterize non-adherent patients and identify patterns of non-adherence will be conducted. The results will be used for the development of a complex tailored intervention for non-adherent patients in Germany.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Maximillian Brockmeyer, MD; Phone Number: : +492118118800; Email: maximilian.brockmeyer@med.uni-duesseldorf.de
• Study Contact Backup: Name: Lisa Dannenberg, MD; Phone Number: +49211811800; Email: ctu@med.uni-duesseldorf.de

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Recruiting
    • University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
    • Contact: Clinical Trial Unit; Phone Number: +492118105315; Email: ctu@med.uni-duesseldorf.de
    • Principal Investigator: Maximillian Brockmeyer, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

patients with coronary artery disease and prescription of atorvastatin or rosuvastin

Description

Inclusion Criteria:

• patients with coronary artery disease
• prescription of atorvastatin or rosuvastatin

Exclusion Criteria:

• < 18 years
• impairment (e.g. dementia)
• language barrier (German)
• end-stage kidney disease with hemodialysis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recrutiment Rate	Recruitment will be assessed by proportion of eligible patients (in %) that agree to participate in the study	through study completion, approximately 1 year
Rate of participating patients (in %) from whom a urine sample can be obtained that is suitable for detection analysis of atorvastatin or rosuvastatin by liquid chromatography/mass spectrometr	Rate of participating patients (in %) from whom a urine sample can be obtained that is suitable for detection analysis of atorvastatin or rosuvastatin by liquid chromatography/mass spectrometry	through study completion, approximately 1 year
Rate of urine samples (in %) from which a valid result of liquid chromatography/mass spectrometry analysis for detection of atorvastatin or rosuvastatin can be obtained.	Rate of urine samples (in %) from which a valid result of liquid chromatography/mass spectrometry analysis for detection of atorvastatin or rosuvastatin can be obtained.	through study completion, approximately 1 year
Average time (in minutes) that is needed by the study personnel to inform the patient about the study, receive written informed consent, hand out and retrieve the study questionnaire, and obtain a urine sample from the participant.	Average time (in minutes) that is needed by the study personnel to inform the patient about the study, receive written informed consent, hand out and retrieve the study questionnaire, and obtain a urine sample from the participant.	through study completion, approximately 1 year
Average time (in minutes) that is needed by the participants to complete the study questionnaire	Average time (in minutes) that is needed by the participants to complete the study questionnaire	through study completion, approximately 1 year
Rate of questions (in %) in the study questionnaire that are completely answered by participants	Rate of questions (in %) in the study questionnaire that are completely answered by participants	through study completion, approximately 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients (in %) in whom atorvastatin or rosuvastatin is detected by liquid chromatography/mass spectrometry analysis of a urine sample	Prevalence of statin adherence assessed by urine analysis	through study completion, approximately 1 year
Rate of patients (in %) who report good adherence atorvastatin or rosuvastatin assessed by Medical Adherence Report Scale (MARS-D)	Prevalence of statin adherence assessed by questionnaire	through study completion, approximately 1 year
Rate of patients (in %) from whom information on concomitant medication other than atorvastatin or rosuvastatin can be obtained from medical records		through study completion, approximately 1 year
Rate of patients (in %) from whom information on comorbidities (i.e., cerebrovascular disease, peripheral artery disease, arterial hypertension, and heart failure, or other comorbidities) can be obtained from medical records		through study completion, approximately 1 year
Rate of patients (in %) from whom socio-demographic information (i.e., level of education and income) can be obtained by the study questionnaire.	Rate of patients (in %) from whom socio-demographic information (i.e., level of education and income) can be obtained by the study questionnaire.	through study completion, approximately 1 year
Rate of patients (in %) from whom information on perceived side-effects of statin therapy can be obtained by the study questionnaire (open question).	Rate of patients (in %) from whom information on perceived side-effects of statin therapy can be obtained by the study questionnaire (open question).	through study completion, approximately 1 year
Rate of patients (in %) from whom information on patients' concerns about medications assessed by Beliefs about Medicines Questionnaire (BMQ-D) can be obtained by the study questionnaire	Rate of patients (in %) from whom information on patients' concerns about medications assessed by Beliefs about Medicines Questionnaire (BMQ-D) can be obtained by the study questionnaire	through study completion, approximately 1 year
Rate of patients (in %) from whom information on anxiety and depression on the Hospital Anxiety and Depression Scale can be obtained by the study questionnaire.	Rate of patients (in %) from whom information on anxiety and depression on the Hospital Anxiety and Depression Scale can be obtained by the study questionnaire.	through study completion, approximately 1 year
Rate of patients (in %) from whom information on health-related quality of life measured by the The Short Form (12) Health Survey (SF-12) can be obtained by the study questionnaire	Rate of patients (in %) from whom information on health-related quality of life measured by the The Short Form (12) Health Survey (SF-12) can be obtained by the study questionnaire	through study completion, approximately 1 year
Rate of patients (in %) from whom information on social integration measured by the Social Integration Index can be obtained by the study questionnaire	Rate of patients (in %) from whom information on social integration measured by the Social Integration Index can be obtained by the study questionnaire	through study completion, approximately 1 year
Rate of patients (in %) from whom information on social support measured by the Oslo-3-Social-Support-Scale can be obtained by the study questionnaire	Rate of patients (in %) from whom information on social support measured by the Oslo-3-Social-Support-Scale can be obtained by the study questionnaire	through study completion, approximately 1 year
Rate of patients (in %) from whom information on health locus of control (open question) can be obtained by the study questionnaire	Rate of patients (in %) from whom information on health locus of control (open question) can be obtained by the study questionnaire	through study completion, approximately 1 year

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Malte Kelm, Prof., Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: adherence; coronary artery disease; Rosuvastatin; atorvastatin; statin; biochemical urine testing of adherebnce
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: BIO-FACTS

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