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Study on Internet Medical Models for the Management of Patients With Hypertension in China

30. Januar 2019 aktualisiert von: China Cardiovascular Association

A Comparative Study on Internet Medical Models and Conventional Medical Models for the Management of Patients With Hypertension in China

The study is a multi-center, randomized, open, and parallel study. Approximately 958 subjects will be enrolled in 16 sites. The random number table will be adopted to conduct cluster randomization per township hospital/community health service center. Patients will be randomized 1:1 to receive blood pressure management in Internet medical model or Conventional medical model. After follow-ups of 3 months and 6 months, the blood pressure in each group will be observed and compared.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Protocol Title:A Comparative Study on Internet Medical Models and Conventional Medical Models for the Management of Patients with Hypertension in China Study Indication:Hypertension Number of Site:16sites Study Duration (from the initiation of the first site to the end of the follow-up for the last subject): 12 months Duration of Treatment and Management: 6 months Planned Number of Subjects:958 subjects, 479 in each group(blood pressure management in Internet medical model, Conventional medical model) Internet Medical Model:Using Internet blood pressure management model: home blood pressure self-monitoring + Internet diagnosis + Maintained or adjusted anti-hypertension drug(s) treatment.

Conventional Medical Model:Using Conventional blood pressure management model: home blood pressure monitoring + face-to-face diagnosis in clinic + Maintained or adjusted anti-hypertension drug(s) treatment.

Inclusion Criteria:

  1. Male or female, 45 to 75 years old (including 45and 75 years);
  2. Two measurements of resting systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg on different days during screening;
  3. Female subjects of child-bearing potential who are willing to adopt one of the following methods for contraception during the study:

    • Oral contraceptive, either combined or progestogen alone.
    • Injectable progestogen.
    • Implants of levonorgestrel.
    • Oestrogenic vaginal ring.
    • Percutaneous contraceptive patches.
    • Intrauterine device or intrauterine system showing that the expected failure rate is less than 1% per year as stated in the product label.
    • Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
  4. Subjects who can understand and perform home blood pressure monitoring as required by the study;
  5. Subjects who voluntarily participate in the study and sign informed consent form.

Exclusion Criteria:

  1. Two measurements of resting systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg on different days during screening;
  2. Subjects with the history of cerebral stroke within 6 months prior to screening;
  3. Subjects with the history of myocardial infarction within 6 months prior to screening;
  4. Subjects with the history of heart failure;
  5. Subjects with the history of atrial fibrillation;
  6. Subjects with the history of coronary artery revascularization;
  7. Subjects with other serious diseases, such as tumor;
  8. Subjects diagnosed as the secondary hypertension;
  9. Subjects with congenital or acquired organic heart disease;
  10. Pregnant or lactant subjects;
  11. Subjects with severe mental disease;
  12. Subjects with abnormal liver and renal function: ALT or AST>2 X upper limit value; Or creatinine > 2X upper limit value
  13. Subjects who were previously diagnosed with diabetes that is currently poorly controlled: FBG>10mmol/L;
  14. Subjects who are unable to conduct blood pressure self-test;
  15. The subject has any other known condition at screening that would compromise subject safety, might affect life expectancy, or making it difficult to successfully manage and follow the subject according to the protocol.

Efficacy Evaluations:

Primary Efficacy Endpoints:

  • Blood pressure control rate of subjects in the two groups at Month 6 Secondary Efficacy Endpoints:
  • Blood pressure control rate of subjects in the two groups at Month 3
  • Blood pressure value of subjects in the two groups at Month 3 and Month 6
  • Change of blood pressure of subjects in the two groups at Month 3 and Month 6
  • Variability of blood pressure of subjects in the two groups at Month 3 and Month 6
  • Treatment compliance of subjects in the two groups at Month 3 and Month 6
  • Medical expense of subjects in the two groups at Month 3 and Month 6
  • Treatment satisfaction of subjects in the two groups at Month 3 and Month 6

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

958

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

45 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Male or female, 45 to 75 years old (including 45 and 75 years);
  2. Two measurements of resting systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg on different days during screening;
  3. Female subjects of child-bearing potential who are willing to adopt one of the following methods for contraception during the study:

    Oral contraceptive, either combined or progestogen alone. Injectable progestogen. Implants of levonorgestrel. Oestrogenic vaginal ring. Percutaneous contraceptive patches. Intrauterine device or intrauterine system showing that the expected failure rate is less than 1% per year as stated in the product label.

    Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).

  4. Subjects who can understand and perform home blood pressure monitoring as required by the study;
  5. Subjects who voluntarily participate in the study and sign informed consent form.

Exclusion Criteria:

  1. Two measurements of resting systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg on different days during screening;
  2. Subjects with the history of cerebral stroke within 6 months prior to screening;
  3. Subjects with the history of myocardial infarction within 6 months prior to screening;
  4. Subjects with the history of heart failure;
  5. Subjects with the history of atrial fibrillation;
  6. Subjects with the history of coronary artery revascularization;
  7. Subjects with other serious diseases, such as tumor;
  8. Subjects diagnosed as the secondary hypertension;
  9. Subjects with congenital or acquired organic heart disease;
  10. Pregnant or lactant subjects;
  11. Subjects with severe mental disease;
  12. Subjects with abnormal liver and renal function: ALT or AST>2 X upper limit value; Or creatinine >2 X upper limit value;
  13. Subjects who were previously diagnosed with diabetes that is currently poorly controlled: FBG>10mmol/L;
  14. Subjects who are unable to conduct blood pressure self-test;
  15. The subject has any other known condition at screening that would compromise subject safety, might affect life expectancy, or making it difficult to successfully manage and follow the subject according to the protocol.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Internet Medical Model
Using Internet blood pressure management model: home blood pressure self-monitoring + Internet diagnosis + Maintained or adjusted anti-hypertension drug(s) treatment.
Subjects in the Internet group should upload blood pressure monitoring data at least once per day. It is highly recommended to upload two pressure monitoring results to capture more blood pressure information. The warning value of blood pressure set in the cloud database is systolic blood pressure ≥ 180mmHg or ≤ 100mmHg and diastolic blood pressure ≥ 110mmHg or ≤ 60mmHg. After enrollment, subjects and physicians communicate via telephone or Internet every two weeks until blood pressure is well controlled judged by physician. Then the frequency of communication will be changed to once a month. Once there are lacks of blood pressure data in 3 days of each week, or. blood pressure values of the subject exceed the warning value in 2 days of consecutive 3 days, the physician will take the initiative to contact the patient for disease inquiry.
Kein Eingriff: Conventional Medical Model
Using Conventional blood pressure management model: home blood pressure monitoring + face-to-face diagnosis in clinic + Maintained or adjusted anti-hypertension drug(s) treatment.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Primary endpoint: blood pressure control rate of subjects in the two groups at Month 6
Zeitfenster: 6 months
Definition of blood pressure control rate is that the percent of subjects with systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg
6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. März 2019

Primärer Abschluss (Voraussichtlich)

1. September 2019

Studienabschluss (Voraussichtlich)

1. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

4. Mai 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Mai 2018

Zuerst gepostet (Tatsächlich)

17. Mai 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Januar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Januar 2019

Zuletzt verifiziert

1. Januar 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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