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Rosuvastatin Adherence App Study in China (eHELP China)

Primary Purpose

Dyslipidemia, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Smart phone based patient support tool
Control application: only for data collection
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyslipidemia focused on measuring smart phone-based, rosuvastatin, duration of treatment, Treatment adherence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Active app

Control app

Arm Description

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.

a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Treatment Adherence
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
Low-Density Lipoprotein-Cholesterol (LDL-C) change from baseline at the Week 24 assessment for subjects who completed 24 weeks of treatment

Full Information

First Posted
April 29, 2015
Last Updated
August 31, 2018
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02433288
Brief Title
Rosuvastatin Adherence App Study in China
Acronym
eHELP China
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2015 (Actual)
Primary Completion Date
October 28, 2016 (Actual)
Study Completion Date
October 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Hyperlipidemia
Keywords
smart phone-based, rosuvastatin, duration of treatment, Treatment adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
885 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active app
Arm Type
Other
Arm Description
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.
Arm Title
Control app
Arm Type
Other
Arm Description
a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
Intervention Type
Other
Intervention Name(s)
Smart phone based patient support tool
Other Intervention Name(s)
Active
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control application: only for data collection
Other Intervention Name(s)
Control
Intervention Description
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).
Primary Outcome Measure Information:
Title
Duration of Treatment
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Fully Adherent Patients
Description
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
Title
Treatment Adherence
Description
The number of reported rosuvastatin tablets taken divided by the total number of days in the study.
Time Frame
Up to 24 weeks
Title
Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan C Carlsson
Organizational Affiliation
AstraZeneca R&D
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100045
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100049
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100700
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
101199
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410005
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400013
Country
China
Facility Name
Research Site
City
Hang Zhou
ZIP/Postal Code
310003
Country
China
Facility Name
Research Site
City
Huzhou
ZIP/Postal Code
313003
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330009
Country
China
Facility Name
Research Site
City
Shandong
ZIP/Postal Code
262700
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
201199
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300142
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Research Site
City
Waifang
ZIP/Postal Code
261500
Country
China
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
10661603
Citation
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.
Results Reference
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Rosuvastatin Adherence App Study in China

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