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

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ClinicalTrials.gov Identifier: NCT04682015
Recruitment Status : Not yet recruiting
First Posted : December 23, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Wenzhou Medical University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Other: WeChat platform group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a WeChat Platform-based Management Intervention on Blood Pressure Control: A Randomized Clinical Trial.
Estimated Study Start Date : February 18, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion with controlled blood pressure at 12 months (defined by ambulatory blood pressure monitoring ) [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Systolic blood pressure (mmHg) at 12 months [ Time Frame: 12 months ]
    Systolic blood pressure (mmHg) at 12 months

  2. Diastolic blood pressure (mmHg) at 12 months [ Time Frame: 12 months ]
    Diastolic blood pressure (mmHg) at 12 months

  3. Medication adherence at 12 months [ Time Frame: 12 months ]
    Medication adherence will be measured by 8-item self-reported medication-taking scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682015


Contacts
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Contact: GaoJun Wu +86 13758715199 liujunemail1@163.com

Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
Investigators
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Principal Investigator: GaoJun Wu hypertension center of the first affiliated hospital of Wenzhou medical university
More Information
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Responsible Party: First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04682015    
Other Study ID Numbers: WMU1H-HTN
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases