Rosuvastatin Adherence App Study in China
Condition: Dyslipidemia; Hyperlipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias
Study type: Interventional

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.
    

Intervention name(s): Smart phone based patient support tool; Control application: only for data collection
Intervention type(s): Other; Other
Intervention description(s): 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.; 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).
Other intervention name(s): Active; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: smart phone-based; rosuvastatin; duration of treatment; Treatment adherence