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

NCT03527563

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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NCT03527563
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study on Internet Medical Models for the Management of Patients With Hypertension in China
Official Title  ICMJE A Comparative Study on Internet Medical Models and Conventional Medical Models for the Management of Patients With Hypertension in China
Brief Summary 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.
Detailed Description

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hypertension
Intervention  ICMJE Behavioral: Internet Medical Model
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.
Study Arms  ICMJE
  • Internet Medical Model
    Using Internet blood pressure management model: home blood pressure self-monitoring + Internet diagnosis + Maintained or adjusted anti-hypertension drug(s) treatment.
    Intervention: Behavioral: Internet Medical Model
  • No Intervention: 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2018)
958
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: yong huo, master13901333060[email protected]
Contact: jie jiang, doctor13601155975[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03527563
Other Study ID Numbers  ICMJE Not Provided
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party China Cardiovascular Association
Study Sponsor  ICMJE China Cardiovascular Association
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:huo yong, masterPeking University First Hospital
PRS Account China Cardiovascular Association
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP