NCT04682015

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
436

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Feb 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 9, 2021

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

December 20, 2020

Last Update Submit

February 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Systolic blood pressure (mmHg) at 12 months

    12 months

  • Diastolic blood pressure (mmHg) at 12 months

    12 months

  • Medication adherence at 12 months

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Control group will receive usual care and follow up in hospitals and community health centers.

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • GaoJun Wu

    hypertension center of the first affiliated hospital of Wenzhou medical university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2020

First Posted

December 23, 2020

Study Start

February 18, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 9, 2021

Record last verified: 2020-12