Effect of a WeChat Platform-based Management Intervention on Blood Pressure Control

Hypertension Clinical Trial

Official title:

Effect of a WeChat Platform-based Management Intervention on Blood Pressure Control: A Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04682015
• Other study ID #: WMU1H-HTN
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: GaoJun Wu
• Phone: +86 13758715199
• Email: liujunemail1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

WeChat is the largest and most popular social media platform in China, In this study, investigators will evaluate the use of management program delivered via WeChat platform in patients with hypertension.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 436
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 18 years with confirmed diagnosis of hypertension

• Office systolic blood pressure (SBP)=140 mmHg and/or diastolic blood pressure (DBP)=90 mmHg, or ambulatory blood pressure monitoring (ABPM) indicating 24- hour SBP =130 mmHg and/or DBP =80 mmHg and/or daytime SBP =135 mmHg and/or DBP =85 mmHg and/or nocturnal SBP =120 mmHg and/or DBP =70 mmHg.

• Patients have smart phone and often use WeChat to communicate with others (including written interaction)

• Patients are willing and able to give informed consent for participation in the trial

Exclusion Criteria:

• Secondary hypertension

• Hypertensive emergency: defined as severe elevations in BP (SBP =180 mmHg and/or DBP=120mmHg) associated with evidence of new or worsening target organ damage, including hypertensive encephalopathy, intracranial hemorrhage, cerebral hemorrhage, subarachnoid hemorrhage, cerebral infarction, heart failure, acute coronary syndrome (unstable angina, acute myocardial infarction), aortic dissection, perioperative hypertension, preeclampsia, and eclampsia

• Refractory hypertension: defined as failure to control BP despite lifestyle changes and use of at least 5 antihypertensive agents of different classes, including a thiazide-type diuretic and a mineralocorticoid receptor antagonist

• Pregnancy or lactation or having pregnancy plan during the study period

• Life expectancy less than 1 year

• Participation in another clinical study or clinical trial in the 3 months prior to the confirmation of eligibility or current user of WeChat platform provided by hypertension center of the first affiliated hospital of Wenzhou medical university

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• WeChat platform group
Participants in the intervention group will receive educational messages related to hypertension, such as impact of hypertension on cardiovascular system, lifestyle adjustment and side effects of antihypertensive drugs. Participants will be reminded to take their blood pressure regularly and enter the blood pressure readings into the WeChat platform. If participants enter extremely high or low readings, they will be asked to seek medical help from doctors. Participants can also consult doctors online via WeChat platform by text and voice messages, or voice calls.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion with controlled blood pressure at 12 months (defined by ambulatory blood pressure monitoring )	mean 24-hour ambulatory blood pressure monitoring (ABPM) <130/80 mmHg, day time blood pressure <135/85 mmHg, and nocturnal blood pressure <120/70 mmHg	12 months
Secondary	Systolic blood pressure (mmHg) at 12 months	Systolic blood pressure (mmHg) at 12 months	12 months
Secondary	Diastolic blood pressure (mmHg) at 12 months	Diastolic blood pressure (mmHg) at 12 months	12 months
Secondary	Medication adherence at 12 months	Medication adherence will be measured by 8-item self-reported medication-taking scale	12 months