A Randomized, Two-arm, Open, 24-week Study to Evaluate the Effect of a Smart Phone-based Patient Support Tool on Duration of Treatment in Patients Prescribed Rosuvastatin in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 885
- 试验地点
- 25
- 主要终点
- Duration of Treatment
研究概览
简要总结
This is a randomized, two-arm, open label, Phase IV clinical trial to evaluate if the provision of a smart phone-based patient support tool prolongs the patient's rosuvastatin treatment duration.
详细描述
This is a randomised, two-arm, open, Phase IV clinical trial to evaluate if the provision of a smart phone-based patient support tool prolongs the patient's rosuvastatin treatment duration.
Patients diagnosed with dyslipidemia or hyperlipidemia at high risk and are treated with rosuvastatin will be offered participation in the study. Patients who accept and sign the Informed Consent will be randomised into one of two study groups:
- Active group: In this group, patients will have access to the smart phone-based patient support tool. The smart phone application used on the patients' smart phones will contain both the patient support tool and the questions for the clinical evaluation in the form of the Rosuvastatin Adherence questionnaire (RAQ), Beliefs about Medicine Questionnaire - General (BMQ-G), and a Lifestyle questionnaire (LSQ) on disease understanding, lifestyle and treatment awareness. Patients in the Active group will also receive feedback on their daily rosuvastatin treatment as entered in the patient support tool.
- Control group: In this group the patients will have no additional support beyond the commonly practiced patient information, i.e. the patients will have no access to the smart phone-based patient support tool. However, a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
In this study, no rosuvastatin will be dispensed to the study participants i.e. patients will purchase their rosuvastatin prescription themselves as in normal practice. All assessments in this study (including blood sampling for the lipid profile) will not be used for guiding the treatment of patients in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Female or male aged 18-80 years, diagnosed with dyslipidemia or hyperlipidemia at high risk and prescribed rosuvastatin
- •Dyslipidemia or hyperlipidemia defined as:
- •LDL-C≥2.6 mmol/L and TG<4.52mmol/L
- •High risk complies with any of the following:
- •Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization [percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)] and other arterial revascularization procedures, ischaemic stroke and peripheral arterial disease (PAD).
- •Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria).
- •Patients with moderate to severe chronic kidney disease [(CKD), glomerular filtration rate (GFR) < 60 mL/min/1.73 m2].
- •Patients must have a smart phone that is compatible with the patient support tool and clinical evaluation questionnaire at their disposal and are comfortable with using of interactive smart phone applications. The required specification for the phone will be determined after completed testing.
- •Ability to read, understand and write Chinese.
- •Statin-naïve or with no statin use during the last 4 weeks prior to enrolment except in the event of patients may receive at most 7 doses of statins during current hospitalization before enrollment.
排除标准
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •Previous enrolment or randomisation in the present study
- •Participation in another clinical study with an investigational product or device during the last 30 days excluding prospective/retrospective register based studies that do not require any extra visits in addition to ordinary health care. Patients who withdraw from this study for any reason cannot re-enter the study.
- •Patients in whom rosuvastatin is contraindicated i.e.
- •patients with hypersensitivity to rosuvastatin or any of the excipients.
- •patients with active liver disease including unexplained, persistent elevations of serum transaminases and have serum transaminase elevation exceeding 3 x the upper limit of normal (ULN).
- •patients with severe renal impairment (creatinine clearance <30 ml/min).
- •patients with myopathy.
- •patients receiving concomitant cyclosporin.
- •females during pregnancy and lactation and women of childbearing potential who are not using appropriate contraceptive measures.
- •Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the patient's safety or successful participation in the study.
研究组 & 干预措施
Active app
The smart phone application used on the patients' smart phones will contain both the patient support tool and the questions for the clinical evaluation in the form of the Rosuvastatin Adherence questionnaire (RAQ), Beliefs about Medicine Questionnaire - General (BMQ-G), (Horne, 1999) and a Lifestyle questionnaire (LSQ) on disease understanding, lifestyle and treatment awareness. Patients in the Active group will also receive feedback on their daily rosuvastatin treatment as entered in the patient support tool.
干预措施: Smart phone based patient support tool (Other)
Control app
a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
干预措施: Control application: only for data collection (Other)
结局指标
主要结局
Duration of Treatment
时间窗: limited to 169 days
The time from randomization to last patient reported visit (prior to the end-of-study visit) to a doctor to get a prescription for rosuvastatin plus the number of days of medicine provided in that last prescription.
次要结局
- Treatment Adherence(Up to 24 weeks)
- Percentage of Fully Adherent Patients(Up to 24 weeks)
- Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline(Baseline and Week 24)