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

Primary Purpose

Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

WeChat platform group

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic blood pressure (mmHg) at 12 months

Diastolic blood pressure (mmHg) at 12 months

Medication adherence at 12 months

Medication adherence will be measured by 8-item self-reported medication-taking scale

Full Information

NCT ID

NCT04682015

First Posted

December 20, 2020

Last Updated

February 6, 2021

Sponsor

First Affiliated Hospital of Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04682015

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 18, 2021 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

436 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

WeChat platform group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion with controlled blood pressure at 12 months (defined by ambulatory blood pressure monitoring )

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Systolic blood pressure (mmHg) at 12 months

Description

Systolic blood pressure (mmHg) at 12 months

Time Frame

12 months

Title

Diastolic blood pressure (mmHg) at 12 months

Description

Diastolic blood pressure (mmHg) at 12 months

Time Frame

12 months

Title

Medication adherence at 12 months

Description

Medication adherence will be measured by 8-item self-reported medication-taking scale

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

GaoJun Wu

Phone

+86 13758715199

liujunemail1@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GaoJun Wu

Organizational Affiliation

hypertension center of the first affiliated hospital of Wenzhou medical university

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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