Dyslipidemia, Hyperlipidemia
Conditions
Keywords
smart phone-based, rosuvastatin, duration of treatment, Treatment adherence
Brief summary
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
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.
Interventions
OTHERSmart 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), (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.
OTHERControl application: only for data collection
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).
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Fully Adherent Patients | Up to 24 weeks | 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. |
| Treatment Adherence | Up to 24 weeks | The number of reported rosuvastatin tablets taken divided by the total number of days in the study. |
| Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline | Baseline and Week 24 | Low-Density Lipoprotein-Cholesterol (LDL-C) change from baseline at the Week 24 assessment for subjects who completed 24 weeks of treatment |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Active Group receive the smart phone-based patient support tool | 431 |
| Control Group provided only the control application and not the smart phone-based patient support tool | 423 |
| Total | 854 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 3 |
| Overall Study | Eligibility criteria not fullfilled | 7 | 3 |
| Overall Study | Lost to Follow-up | 2 | 14 |
| Overall Study | Severe non-compliance to protocol | 13 | 7 |
| Overall Study | Withdrawal by Subject | 101 | 99 |
Baseline characteristics
| Characteristic | Control Group | Total | Active Group |
|---|---|---|---|
| Age, Continuous | 54.5 Years STANDARD_DEVIATION 9.51 | 54.6 Years STANDARD_DEVIATION 9.65 | 54.7 Years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 423 Participants | 854 Participants | 431 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 423 Participants | 854 Participants | 431 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 154 Participants | 315 Participants | 161 Participants |
| Sex: Female, Male Male | 269 Participants | 539 Participants | 270 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 23 / 431 | 11 / 423 |
Outcome results
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.
Time frame: limited to 169 days
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group | Duration of Treatment | 156.7 days | Standard Error 2.24 |
| Control Group | Duration of Treatment | 146.0 days | Standard Error 2.69 |
p-value: 0.0019Log Rank
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.
Time frame: Up to 24 weeks
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Group | Percentage of Fully Adherent Patients | 4.4 % of patients |
| Control Group | Percentage of Fully Adherent Patients | 9.9 % of patients |
p-value: 0.0017Chi-squared
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
Time frame: Baseline and Week 24
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group | Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline | -21.09 % change | Standard Error 1.4 |
| Control Group | Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline | -21.72 % change | Standard Error 1.4 |
p-value: 0.751495% CI: [-3.27, 4.53]ANCOVA
Secondary
Treatment Adherence
The number of reported rosuvastatin tablets taken divided by the total number of days in the study.
Time frame: Up to 24 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group | Treatment Adherence | 37.95 % adherence | Standard Deviation 32.916 |
| Control Group | Treatment Adherence | 58.19 % adherence | Standard Deviation 36.257 |
p-value: <0.000195% CI: [-26.91, -13.57]t-test, 2 sided
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.
Time frame: Up to 24 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group | Reported Treatment Adherence | 94.63 % adherence | Standard Deviation 18.347 |
| Control Group | Reported Treatment Adherence | 96.01 % adherence | Standard Deviation 14.316 |
p-value: 0.393995% CI: [-4.56, 1.8]t-test, 2 sided