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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Other: WeChat platform group

• Study Type: Interventional
• Enrollment (Anticipated): 436
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group will be enrolled into WeChat platform. Participants will receive health education materials, monitor blood pressure at home and sent the blood pressure record to the platform and consult doctors online via platform.	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.
No Intervention: Control; Control group will receive usual care and follow up in hospitals and community health centers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (mmHg) at 12 months	Systolic blood pressure (mmHg) at 12 months	12 months
Diastolic blood pressure (mmHg) at 12 months	Diastolic blood pressure (mmHg) at 12 months	12 months
Medication adherence at 12 months	Medication adherence will be measured by 8-item self-reported medication-taking scale	12 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: GaoJun Wu, hypertension center of the first affiliated hospital of Wenzhou medical university

Study record dates

Study Major Dates

• Study Start (Anticipated): February 18, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: WMU1H-HTN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No