NCT02433288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
885

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 20, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

April 29, 2015

Results QC Date

September 28, 2017

Last Update Submit

August 31, 2018

Conditions

DyslipidemiaHyperlipidemia

Keywords

smart phone-basedrosuvastatinduration of treatmentTreatment adherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Percentage of Fully Adherent Patients

    Up to 24 weeks

  • Treatment Adherence

    Up to 24 weeks

  • Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline

    Baseline and Week 24

Study Arms (2)

Active app

OTHER

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

Control app

OTHER

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

Interventions

Smart phone based patient support toolOTHER

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.

Also known as: Active
Active app
Control application: only for data collectionOTHER

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).

Also known as: Control
Control app

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Research Site

Beijing, 100029, China

Location

Research Site

Beijing, 100034, China

Location

Research Site

Beijing, 100045, China

Location

Research Site

Beijing, 100049, China

Location

Research Site

Beijing, 100191, China

Location

Research Site

Beijing, 100700, China

Location

Research Site

Beijing, 100730, China

Location

Research Site

Beijing, 101199, China

Location

Research Site

Changsha, 410005, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Chongqing, 400013, China

Location

Research Site

Hangzhou, 310003, China

Location

Research Site

Huzhou, 313003, China

Location

Research Site

Nanchang, 330009, China

Location

Research Site

Shandong, 262700, China

Location

Research Site

Shanghai, 200050, China

Location

Research Site

Shanghai, 200072, China

Location

Research Site

Shanghai, 200240, China

Location

Research Site

Shanghai, 201199, China

Location

Research Site

Tianjin, 300142, China

Location

Research Site

Tianjin, 300192, China

Location

Research Site

Tianjin, 300211, China

Location

Research Site

Waifang, 261500, China

Location

Research Site

Wenzhou, 325000, China

Location

Research Site

Wuhan, 430022, China

Location

Related Publications (1)

  • 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.

    PMID: 10661603BACKGROUND

MeSH Terms

Conditions

DyslipidemiasHyperlipidemiasTreatment Adherence and Compliance

Interventions

ExerciseData Collection

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Limitations and Caveats

The secondary endpoints Percentage of fully adherent patients and Treatment adherence may be impacted by the response frequency to the relevant questions. There is a tendency to a higher response frequency in the Control group in this study.

Results Point of Contact

Title
Traxler, Barry M
Organization
AstraZeneca
barry.traxler@astrazeneca.com
+1 301 398 0657

Study Officials

  • Stefan C Carlsson

    AstraZeneca R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 4, 2015

Study Start

July 20, 2015

Primary Completion

October 28, 2016

Study Completion

October 28, 2016

Last Updated

January 31, 2019

Results First Posted

January 31, 2019

Record last verified: 2018-08

Locations

CN(25)