Feasibility of BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease: The BIO-FACTS Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Feasibilty study of biochemical urine analysis of adherence to high intensity statin therapy in outpatients with coronary artery disease
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coronary artery disease
- •prescription of atorvastatin or rosuvastatin
排除标准
- •< 18 years
- •impairment (e.g. dementia)
- •language barrier (German)
- •end-stage kidney disease with hemodialysis
结局指标
主要结局
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.
时间窗: 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.
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.
时间窗: 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 participants to complete the study questionnaire
时间窗: through study completion, approximately 1 year
Average time (in minutes) that is needed by the participants to complete the study questionnaire
Rate of questions (in %) in the study questionnaire that are completely answered by participants
时间窗: through study completion, approximately 1 year
Rate of questions (in %) in the study questionnaire that are completely answered by participants
Recrutiment Rate
时间窗: through study completion, approximately 1 year
Recruitment will be assessed by proportion of eligible patients (in %) that agree to participate in the study
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
时间窗: 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 spectrometry
次要结局
- Rate of patients (in %) in whom atorvastatin or rosuvastatin is detected by liquid chromatography/mass spectrometry analysis of a urine sample(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 information on health locus of control (open question) can be obtained by the study questionnaire(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)(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.(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(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).(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(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(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.(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(through study completion, approximately 1 year)