Compare the Effects of Telemedicine Approach With Usual Care in Hypertension Management in China

NCT02919033 | Unknown

• 1 other identifier: SHDC12015308
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China.

Conditions

Hypertension

Keywords

randomized controlled trial; telemedicine; hypertension; primary care; medication adherence

Outcome Measures

Primary Outcomes (1)

• Changes in mean SBP

  The primary endpoint of the trial is changes in mean SBP from baseline (T1) to 12 months (T3) measured using the BP tele-monitor (Bliss BL928). The 12 months BP readings will be determined by taking the average of three BP measurements at the follow-up visit to the CHC. All BP data are collected and uploaded simultaneously to the trial database.

  From baseline (T1) to 12 months (T3)

Secondary Outcomes (3)

• Changes in mean DBP

  From baseline (T1) to 12 months (T3)

• Hypertension control rate

  From baseline (T1) to 6 months (T2) and 12 months (T3)

• Anti-hypertensive medication adherence

  At baseline (T1) and 12 months (T3).

Study Arms (3)

Usual care (UC)

PLACEBO COMPARATOR

Patients are managed by their PCPs at the registered CHCs as usual.

Other: Usual care

Self-management

EXPERIMENTAL

* BP tele-monitor \& App based self-management supports * Patient proficiency training

Device: Self-management

PCTM intervention

EXPERIMENTAL

* BP tele-monitor \& App-based self-management supports * Patient proficiency training * PCP \& cardiologist training of using Web-based analytics * Proactive and interactive care by PCPs and cardiologists

Other: PCTM intervention

Interventions

Usual care OTHER

The hypertension care of this arm complies with the national guideline and includes designated follow-ups by PCPs once every 1-3 months for stage-1 (≥ 140/90 mm Hg) hypertension patients, once every 1 month for stage-2 (≥ 160/100 mm Hg) and once every 2 weeks for stage-3 (≥ 180/110 mm Hg) patients.

Usual care (UC)

Self-management DEVICE

* Usual care * Patients receive a BP telemedicine system developed by CareLinker Inc. (Shanghai, China) to facilitate BP self-management in addition to all the usual care components. The system consists of: 1) a BP tele-monitor with embedded GSM module that can upload BP readings; 2) a mobile App that allows patients to manually input healthcare data, display history BP measurements and lab test results, receive personalized lifestyle coaching contents and medication reminders, and communicate with PCPs through text-messaging. * All patients receive proficiency training in using the BP tele-monitor, and mobile App.

Self-management

PCTM intervention OTHER

* Usual care * Self-management * PCPs and cardiologists use the secure CareLinker website to review patient data including BP measurements, lab test results and medications in use and comorbidities. The auto analytics tools of the website reveal BP average, BP trend, and risk score of each patient. Text alerts of abnormal BP variability will be pushed to PCPs' App when they occur and proactive interventions including phone consultation and medication dosage adjustment will be offered. A case review session will be set once every 1-2 months for PCPs and cardiologists to exam patients' disease progresses. The proprietary web-based analytic module also produces automated individualized medication recommendations to PCPs. * PCPs and cardiologists receive training of the CareLinker website.

PCTM intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 21 years or older
• a clinical diagnosis of hypertension with uncontrolled BP in the previous three months, currently taking or about to take anti-hypertensive medications
• received high school or above level of education
• active user of smart phone (Android or Apple) and mobile Apps
• the average of three BP measurements during the screening visit at the CHC is ≥ 140/90 mm Hg, or ≥ 130/80 mm Hg if the patient has diabetes or renal diseases;
• being able to give informed consent.

You may not qualify if:

• acute coronary syndrome
• heart failure
• cardiac arrhythmia
• stroke within the past three months
• renal failure
• cancer
• dementia, severe or acute psychiatric illness, pregnancy or intention to be pregnant in the next 18 months, and hospitalization within 3 months.
• circumference \>32 centimeters that may affect the accuracy of BP measurement due to cuff size limit of the tele-monitor's, and unwillingness to comply with the 12 month intervention duration.

Sponsors & Collaborators

• Xu Lei: lead

Study Sites (1)

Shanghai Chest Hostpital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

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MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lei Xu, Master

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Xu, Master

CONTACT

86-21-32260806; waqyl@126.com

Kai Liu, Doctor

CONTACT

86-18918656956; liuk@carelinker.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 29, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 29, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)