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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active app | Other | 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. |
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| Control app | Other | a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart phone based patient support tool | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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].
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.
Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the patient's safety or successful participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan C Carlsson | AstraZeneca R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | 100029 | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10661603 | Background | Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4. |
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A total of 885 patients were randomized (1:1) to two groups: an active group which received the smart phone-based patient support tool and a control application used for data collection only.
885 patients signed Inform Consent and were randomized in the study, 443 subjects in the active group and 442 subjects in the control group. 320 (72.2%) and 316 (71.5%) patients, respectively, completed the study. The overall completion rate was 71.9%. 31 patients (12 and 19 respectively) was not successful in receiving the relevant application.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Group | receive the smart phone-based patient support tool |
| FG001 | Control Group | provided only the control application and not the smart phone-based patient support tool |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Control application: only for data collection | Other | 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). |
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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 |
| Beijing |
| 100034 |
| China |
| Research Site | Beijing | 100045 | China |
| Research Site | Beijing | 100049 | China |
| Research Site | Beijing | 100191 | China |
| Research Site | Beijing | 100700 | China |
| Research Site | Beijing | 100730 | China |
| Research Site | Beijing | 101199 | China |
| Research Site | Changsha | 410005 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Chongqing | 400013 | China |
| Research Site | Hangzhou | 310003 | China |
| Research Site | Huzhou | 313003 | China |
| Research Site | Nanchang | 330009 | China |
| Research Site | Shandong | 262700 | China |
| Research Site | Shanghai | 200050 | China |
| Research Site | Shanghai | 200072 | China |
| Research Site | Shanghai | 200240 | China |
| Research Site | Shanghai | 201199 | China |
| Research Site | Tianjin | 300142 | China |
| Research Site | Tianjin | 300192 | China |
| Research Site | Tianjin | 300211 | China |
| Research Site | Waifang | 261500 | China |
| Research Site | Wenzhou | 325000 | China |
| Research Site | Wuhan | 430022 | China |
| COMPLETED |
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| NOT COMPLETED |
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The baseline characteristics were summarized based on the FAS, which comprised all randomized patients who received the study application successfully.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Group | receive the smart phone-based patient support tool |
| BG001 | Control Group | provided only the control application and not the smart phone-based patient support tool |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FAS | Posted | Mean | Standard Error | days | limited to 169 days |
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| Secondary | 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. | FAS | Posted | Number | % of patients | Up to 24 weeks |
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| Secondary | Treatment Adherence | The number of reported rosuvastatin tablets taken divided by the total number of days in the study. | FAS | Posted | Mean | Standard Deviation | % adherence | Up to 24 weeks |
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| Post-Hoc | Reported Treatment Adherence | The number of reported rosuvastatin tablets taken divided by the total number of days reported during the treatment. This is eliminated any missing data from the calculation. | FAS | Posted | Mean | Standard Deviation | % adherence | Up to 24 weeks |
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| Secondary | 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 | FAS | Posted | Mean | Standard Error | % change | Baseline and Week 24 |
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177±7 days
This was an evaluation of the smart phone-based patient support tool, and rosuvastatin was not considered an investigational product for this study. There was no requirement to report AEs as part of the study, except the ones meeting the SAE criteria.
Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Group | receive the smart phone-based patient support tool | 23 | 431 | 0 | 0 | ||
| EG001 | Control Group | provided only the control application and not the smart phone-based patient support tool | 11 | 423 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left carotid artery occlusion | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Right carotid artery stenosis | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Cardiac insufficiency | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Cardiac neurosis | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Complete right bundle branch block | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Coronary atherosclerosis | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Coronary atherosclerotic heart disease | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Coronary heart disease | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Dilated cardiomyopathy | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Persistent atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Unstable angina pectoris | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Ventricular premature beat | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Macular edema | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Dizziness | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Somatization disorder | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Limb mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
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| Acute cerebral infarction | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Acute renal insufficiency | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Chronic glomerulonephritis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Pulmonary infection | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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The secondary endpoints Percentage of fully adherent patients and Treatment adherence may be impacted by the response frequency to the relevant questions. There is a tendency to a higher response frequency in the Control group in this study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Traxler, Barry M | AstraZeneca | +1 301 398 0657 | barry.traxler@astrazeneca.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006949 | Hyperlipidemias |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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