Improve Hypertension Monitoring and Self-management by Using mHealth

NCT ID: NCT02632838

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-11-30

Brief Summary

Monitoring and self-management are important components of effective chronic disease care and improved patient outcomes. With the rapid development of integration of mobile health technology (mHealth) into health care delivery services, mHealth intervention provides a great opportunity to improve the efficiency of chronic disease management. However, little is known about whether mHealth interventions can effectively impact the health and health care outcomes in underserved populations. This pilot study will assess the preliminary effectiveness of a mobile-based health intervention in an urban underserved community with a high incidence of hypertension. It is hypothesized that patients with hypertension will experience improved outcomes due to the use of a mHealth application compared with patients who are not using the application. The findings from this study will advance our understanding of the utility of mHealth interventions among underserved populations and generate evidence to support this new health care delivery approach in underserved urban communities.

In this study, two hypotheses will be tested:

1. Hypertension patients using the mHealth application exhibit a greater decrease in blood pressure and better maintenance over a 6-month period compared to those who receive standard care.

2. Hypertension patients using the mHealth application will exhibit more effective self-management as compared to those who receive standard care.

Detailed Description

Based on the J&HCHC's current practice, all hypotension patients are required to visit the nurses for their regular hypertension care every week. Therefore, all participants in this study will be asked to visit J&HCHC once a week for the 6-month period as usual. The standard follow-up group will receive regular hypertension care as usual which consists: nursing assessment, medication management, patient education, follow up and continuing care. Home monitoring is a great way to help detect and monitor high blood pressure. The mHealth group will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor on a daily basis at HOME and also will be asked to visit J&HCHC once a week to receive the regular hypertension care for the 6-month period as usual. After all participants complete their 6-month study, the study data will be collected from Electronic Health Record (McKesson) and patient's mobile devices.

In this study, a FDA 510K approved device, iHealth BP7-Wireless Blood Pressure Wrist Monitor (iHealth Lab Inc.), will be utilized for the mHealth group. This is a fully automatic wrist cuff blood pressure monitor that uses the oscillometric principle to measure blood pressure and pulse rate. The monitor works with mobile devices to test, track and share vital blood pressure data. There are no physical risks associated with using this device to take the blood pressure at home. Besides the FDA 510K approval, iHealth BP7-Wireless Blood Pressure Wrist Monitor has also CE medical certification (Europe) and ESH Certification (European Society of Hypertension). iHealth BP7-Wireless Blood Pressure Wrist Monitor works with both Apple and Android devices. Apple iOS devices requires iOS version 5.0 or higher and Android devices requires operating system 3.0 or later.

iHealth BP7-Wireless Blood Pressure Wrist Monitor can maintain a maximum of 10,000 measurements or three years of usage. In addition, iHealth BP7-Wireless Blood Pressure Wrist Monitor has a Bluetooth sync system that will pair with both Apple and Android devices. The synchronization allows the monitor to send systolic and diastolic blood pressures and pulse rate to patients' mobile devices. The free iHealth MyVitals app then automatically keeps a history of BP data and gives patient the option to share their blood pressure data information with their healthcare provider. In addition to keep the data on the mobile device, patient also receive a free and secure cloud account. Vital data on the cloud allows patients to access from any computer and to share readings with their healthcare provider, if they choose to do so. With this type of information available, patients will be able to do self-management and nurses will be able to actively provide intervention activities. Conceptual diagram for iHealth BP-7 Wireless Blood Pressure Wrist Monitor device, apps and cloud sever are presented in research protocol

A pilot version of a parallel-group 6-month randomized controlled trial (RCT) will be utilized to this study. 30 participants will be randomly assigned either to standard care and treatment (the standard follow up group) or to the mobile intervention group (the mHealth group). For the standard follow up group, participants' BP will be measured in an upright seated position with feet flat on the floor while being at rest for at least 5 minutes. During each visit, participants will be measured twice or more, separated by two minutes in each arm. The Welch Allyn Spot Vital Signs LXi electronic blood pressure monitor will be utilized for this group. Participants' systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse will be measured and recorded by the J&HCHC nurses. For the mHealth group participants' BP data will be collected in two ways: iHealth's MyVitals and office visit BP records. The office visit BP will be measured in a manner identical to the standard follow up group. iHealth's MyVitals BP data were collected by a project research assistant every week. Data were aggregated, and an average of the BP readings recorded at baseline (beginning of the study), at three months and six months will be used for data analysis.

BP monitoring adherence for the standard follow-up group will be calculated by dividing the total number of office visits to measure BP by the total number of expected visits (one office BP measurement every week for 6 months). BP monitoring adherence for the mHealth group will be calculated by dividing the total number of times iHealth BP-7 was used to measure BP by the total number of expected times it should have been used (one BP measurement performed every day for 6 months).

Improved health related quality of life, patient self-efficacy, and reduced hospital utilization will be measured. Medical Outcomes Study 36-Item Short- Form Health Survey (SF-36) will be utilized to measure the health-related quality of life. Patient self-efficacy and treatment adherence will be measured by the Medication Adherence Self-Efficacy Scale (MASES). Self-reported hospital utilization rate will be used to measure reduced hospital utilization. Participants hospital utilization data will be retrieved from their electronic medical record.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

the mHealth Group

The mHealth group will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor on a daily basis at HOME and also will be asked to visit community health center once a week to receive the regular hypertension care for the 6-month period as usual.

Group Type: EXPERIMENTAL

iHealth BP7-Wireless Blood Pressure Wrist Monitor,

Intervention Type: DEVICE

The mHealth group will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor at home. This monitor is a fully automatic wrist cuff blood pressure monitor that uses the oscillometric principle to measure blood pressure and pulse rate. The monitor works with mobile devices to test, track and share vital blood pressure data. The Bluetooth sync system allows the monitor to send BP measures and pulse rate to patients' mobile devices. The free iHealth app automatically keeps a history of BP data and gives patient the option to share their blood pressure data with their provider. In addition to keep the data on the mobile device, patient also receive a free and secure cloud account. Vital data on the cloud allows patients to access from any computer and to share with their provider.

the Standard Follow-up Group

The standard follow-up group will receive regular hypertension care as usual which consists: nursing assessment, medication management, patient education, follow up and continuing care in the community health center

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iHealth BP7-Wireless Blood Pressure Wrist Monitor,

The mHealth group will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor at home. This monitor is a fully automatic wrist cuff blood pressure monitor that uses the oscillometric principle to measure blood pressure and pulse rate. The monitor works with mobile devices to test, track and share vital blood pressure data. The Bluetooth sync system allows the monitor to send BP measures and pulse rate to patients' mobile devices. The free iHealth app automatically keeps a history of BP data and gives patient the option to share their blood pressure data with their provider. In addition to keep the data on the mobile device, patient also receive a free and secure cloud account. Vital data on the cloud allows patients to access from any computer and to share with their provider.

Intervention Type: DEVICE

Other Intervention Names

510(k) number: 121470

Eligibility Criteria

Inclusion Criteria

1)18-64 year-old residents of one of the three housing developments and use our community health center as their primary care service

2) Subjects who have been documented with uncontrolled blood pressure, and whose BP measures 140/90 mmHg or higher for either of the two numbers

3) Subjects must have a compatible mobile device

4) Nurses in this study must be who are currently working at our community health center

Exclusion Criteria

1. Patients under the age of 18 years old

2. Pregnant women

3. Patient with serious arrhythmia

4. Patient with preeclamptic

5. Patient who cannot speak/read English.

6. Patients using University Hospital or other clinical offices as their primary care service

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Peijia Zha

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peijia Zha, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Peijia Zha

Newark, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Pro20150001419

Identifier Type: -

Identifier Source: org_study_id