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Rosuvastatin Adherence App Study in China (eHELP China)

31. august 2018 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

885

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Annen: 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.
Andre navn:
  • Aktiv
Annen: Control app
a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
Annen: 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).
Andre navn:
  • Styre

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of Treatment
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Fully Adherent Patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Etterforskere

  • Studieleder: Stefan C Carlsson, AstraZeneca R&D

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. juli 2015

Primær fullføring (Faktiske)

28. oktober 2016

Studiet fullført (Faktiske)

28. oktober 2016

Datoer for studieregistrering

Først innsendt

29. april 2015

Først innsendt som oppfylte QC-kriteriene

29. april 2015

Først lagt ut (Anslag)

4. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D3560C00088

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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