Rosuvastatin Adherence App Study in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dyslipidemia, Hyperlipidemia

Intervention / Treatment
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* Other: Smart phone based patient support tool
* Other: Control application: only for data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active app<br>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. | Other: Smart phone based patient support tool<br>* 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.<br>* Other names: Active;|
| Other: Control app<br>a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ). | Other: Control application: only for data collection<br>* 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).<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Treatment | 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. | limited to 169 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Fully Adherent Patients | The number of patients who answered 'Yes' to Q4 of Rosuvastatin Adherence Questionnaire (RAQ) at all time points divided by the total number of randomized patients. | Up to 24 weeks | 
| Treatment Adherence | The number of reported rosuvastatin tablets taken divided by the total number of days in the study. | Up to 24 weeks | 
| Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline | Low-Density Lipoprotein-Cholesterol (LDL-C) change from baseline at the Week 24 assessment for subjects who completed 24 weeks of treatment | Baseline and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smart phone-based, rosuvastatin, duration of treatment, Treatment adherence