Rosuvastatin adherence app study in China - eHELP China

Study identifier:D3560C00088

ClinicalTrials.gov identifier:NCT02433288

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Dyslipidemia

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

885

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 20 Jul 2015

Primary Completion Date: 28 Oct 2016

Study Completion Date: 28 Oct 2016

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Verification:

Verified 01 Aug 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Other: Active app 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 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 Name: Active
Other: Control app 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 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 Name: Control

Arms

Assigned Interventions

Other: Active app
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
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 Name: Active

Other: Control app
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
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 Name: Control

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Stefan C Carlsson

AstraZeneca R&D