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

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: Hypertension
• Intervention / Treatment: Behavioral: Internet Medical Model

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• Sponsor: China Cardiovascular Association
• Collaborators: Pfizer

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

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: Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension

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