Clinical trial NCT03527563: Study on Internet Medical Models for the Management of Patients With Hypertension in China
Official title: A Comparative Study on Internet Medical Models and Conventional Medical Models for the Management of Patients With Hypertension in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: China Cardiovascular Association
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-05-17
Enrollment: 958
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Primary endpoint: blood pressure control rate of subjects in the two groups at Month 6
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University First Hospital
name: huo yong, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pickering TG, Miller NH, Ogedegbe G, Krakoff LR, Artinian NT, Goff D; American Heart Association; American Society of Hypertension; Preventive Cardiovascular Nurses Association. Call to action on use and reimbursement for home blood pressure monitoring: a joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. J Cardiovasc Nurs. 2008 Jul-Aug;23(4):299-323. doi: 10.1097/01.JCN.0000317429.98844.04.
citation: Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure-related disease, 2001. Lancet. 2008 May 3;371(9623):1513-8. doi: 10.1016/S0140-6736(08)60655-8.