Rosuvastatin Adherence App Study in China (eHELP China)

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Hyperlipidemia
• Intervention / Treatment: Other: Smart phone based patient support tool; Other: Control application: only for data collection

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.

• Study Type: Interventional
• Enrollment (Actual): 885
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Research Site
  • Beijing, China, 100034
    • Research Site
  • Beijing, China, 100029
    • Research Site
  • Beijing, China, 100191
    • Research Site
  • Beijing, China, 100049
    • Research Site
  • Beijing, China, 100045
    • Research Site
  • Beijing, China, 100700
    • Research Site
  • Beijing, China, 101199
    • Research Site
  • Changsha, China, 410005
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Chongqing, China, 400013
    • Research Site
  • Hang Zhou, China, 310003
    • Research Site
  • Huzhou, China, 313003
    • Research Site
  • Nanchang, China, 330009
    • Research Site
  • Shandong, China, 262700
    • Research Site
  • Shanghai, China, 200072
    • Research Site
  • Shanghai, China, 201199
    • Research Site
  • Shanghai, China, 200240
    • Research Site
  • Shanghai, China, 200050
    • Research Site
  • Tianjin, China, 300142
    • Research Site
  • Tianjin, China, 300211
    • Research Site
  • Tianjin, China, 300192
    • Research Site
  • Waifang, China, 261500
    • Research Site
  • Wenzhou, China, 325000
    • Research Site
  • Wuhan, China, 430022
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Stefan C Carlsson, AstraZeneca R&D

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2015
• Primary Completion (Actual): October 28, 2016
• Study Completion (Actual): October 28, 2016

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): May 4, 2015

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: rosuvastatin; Treatment adherence; smart phone-based; duration of treatment
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: D3560C00088