Dyslipidemia Clinical Trial
Official title:
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
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:
- 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.
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