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Rosuvastatin Adherence App Study in China (eHELP China)

31 augusti 2018 uppdaterad av: AstraZeneca

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

885

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.
Övrig: 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.
Andra namn:
  • Aktiva
Övrig: Control app
a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
Övrig: 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).
Andra namn:
  • Kontrollera

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of Treatment
Tidsram: limited to 169 days
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Fully Adherent Patients
Tidsram: Up to 24 weeks
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
Tidsram: Up to 24 weeks
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
Tidsram: Baseline and Week 24
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Utredare

  • Studierektor: Stefan C Carlsson, AstraZeneca R&D

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 juli 2015

Primärt slutförande (Faktisk)

28 oktober 2016

Avslutad studie (Faktisk)

28 oktober 2016

Studieregistreringsdatum

Först inskickad

29 april 2015

Först inskickad som uppfyllde QC-kriterierna

29 april 2015

Första postat (Uppskatta)

4 maj 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 januari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D3560C00088

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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