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

January 30, 2019 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

958

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Internet Medical Model
Using Internet blood pressure management model: home blood pressure self-monitoring + Internet diagnosis + Maintained or adjusted anti-hypertension drug(s) treatment.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint: blood pressure control rate of subjects in the two groups at Month 6
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Cardiovascular Association

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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