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The Adherence to Oral Anticoagulant in Chinese Patients With NVAF (NVAF)

20. juni 2021 opdateret af: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study of Compliance and Influencing Factors in Chinese Patients With Nonvalvular Atrial Fibrillation (NVAF) to Oral Anticoagulant

Investigate the compliance of oral anticoagulants in Chinese NVAF patients and find out the causes, so as to provide basis for formulating effective measures to improve the compliance of oral anticoagulants.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. The general information about these patients was recorded such as gender, age, smoking history, drinking history, heart failure, hypertension, diabetes, coronary heart disease, stroke history, TIA history, peripheral vascular disease, etc. CHA2DS2-VASc score and HAS-BLED score were recorded.
  2. Medication information and follow-up information was collected.For the patients included in the study, the medication records of oral anticoagulants (outpatient, emergency, hospitalization), adverse reactions, anticoagulant use history, drug withdrawal or dressing change, disease changes, etc. within three years were recorded by referring to the patient's medical records.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: zhang xiaoyu, master
  • Telefonnummer: 18858160685
  • E-mail: 474430517@qq.com

Studiesteder

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 086
        • Chang Cuie
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • huang yuwen, master

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Through the hospital information system (HIS), the information of patients using warfarin, dabigatran and rivaroxaban during 2016.1-2-2021.1 was retrieved

Beskrivelse

Inclusion Criteria:

NVAF; CHA2DS2-VASc≥2（femal≥3）; After starting the medication, the duration of continuous medication was more than 3 months

Exclusion Criteria:

The patients had the records of anticoagulants in other hospitals; Patients lost to follow-up; Patients who do not need long-term anticoagulants after successful radiofrequency ablation or left atrial appendage occlusion. The follow-up time was 3 years or the following conditions occurred: the patient's condition changed and no longer used oral anticoagulants or died, the follow-up was stopped.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
dabigatran group
NVAF patients who taking dabigatran capsule 110mg，bid during 2016.2-2021.1，the duration of continuous medication was more than 3 months.PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran.
Andet: adherence
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin
Rivaroxaban group
NVAF patients who taking rivaroxaban tablet 15mg，bid during 2016.2-2021.1，the duration of continuous medication was more than 3 months.PDC value and mmas-8 scale were used to evaluate the compliance of patients with dabigatran. PDC value and mmas-8 scale were used to evaluate the compliance of patients with rivaroxaban.
Andet: adherence
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin
wafarin group
NVAF patients who taking wafarin tablet during 2016.2-2021.1，the duration of continuous medication was more than 3 months， the dosage is adjusted according to INR. MMAS-8 scale was used to evaluate the compliance of patients with rivaroxaban.evaluate the compliance of patients with wafarin.
Andet: adherence
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The long-term compliance of oral anticoagulants in NVAF patients was compared among warfarin group, dabigatran group and rivaroxaban group.
Tidsramme: 6 months
In this study, the eight item Morisky medication adherence scale (MMAS-8) was used to compare the long-term compliance of patients with warfarin, dabigatran axetil and rivaroxaban. The proportion of days covered (PDC) was used to compare the long-term compliance of patients with dabigatran and rivaroxaban.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Explore the influence of different factors on patients' compliance, and to find out the factors influencing patients' long-term compliance, so as to provide basis for formulating strategies to improve patients' long-term compliance.
Tidsramme: 6 months
Data of all influencing factors included in CHA2DS2-VASc score scale, such as age hypertension，heart failure, diabetes, women and vascular diseases， as well as region, medical insurance category, education level, anticoagulant use history and HAS-BLED score
6 months
Through multivariate logistic regression analysis, to clarify the impact of various factors on long-term compliance of patients.
Tidsramme: 6 months
Univariate analysis of significant variables, further by multivariate logistic regression analysis
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Efterforskere

  • Ledende efterforsker: huang yuwen, master, The Second Affiliated Hospital of Medical College of Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

20. juli 2021

Primær færdiggørelse (Forventet)

6. juni 2022

Studieafslutning (Forventet)

10. juni 2023

Datoer for studieregistrering

Først indsendt

10. juni 2021

Først indsendt, der opfyldte QC-kriterier

20. juni 2021

Først opslået (Faktiske)

29. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020-966

Plan for individuelle deltagerdata (IPD)

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