Improve Hypertension Monitoring and Self-management by Using mHealth

NCT02632838 | Completed Results

• 1 other identifier: Pro20150001419
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

Hypertension; mHealth; underserved community

Outcome Measures

Primary Outcomes (1)

• Blood Pressure (BP) Change

  BP change defined as monthly average BP in both systolic and diastolic blood pressure decrease. BP decline were expected as early as 3 month of intervention and kept to decreasing over 6 month period. For the mHealth 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, 3-month and 6-month were used for data analysis. For the standard follow up group, participants' BP was measured in an upright seated position with feet flat on the floor while being at rest for at least 5 minutes. During each week's office visit, participants were measured twice or more, separated by two minutes in each arm. The Welch Allyn Spot Vital Signs LXi electronic blood pressure monitor was utilized for this group. Data were aggregated, and an average of the BP readings recorded at baseline, 3-month and 6-month were used for data analysis.

  baseline, 3 monthly intervals over 6 months of follow up

Secondary Outcomes (1)

• Blood Pressure Monitoring Adherence

  6 months

Other Outcomes (3)

• Health-Related Quality of Life

  baseline and 6-month

• Patient Self-efficacy

  baseline and 6-month

• Hospital Admissions for Hypertension Related Illnesses

  6 months

Study Arms (2)

the mHealth Group

EXPERIMENTAL

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.

Device: iHealth BP7-Wireless Blood Pressure Wrist Monitor,

the Standard Follow-up Group

NO INTERVENTION

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

Interventions

iHealth BP7-Wireless Blood Pressure Wrist Monitor, 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.

Also known as: 510(k) number: 121470

the mHealth Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• )18-64 year-old residents of one of the three housing developments and use our community health center as their primary care service
• \) Subjects who have been documented with uncontrolled blood pressure, and whose BP measures 140/90 mmHg or higher for either of the two numbers
• \) Subjects must have a compatible mobile device
• \) Nurses in this study must be who are currently working at our community health center

You may not qualify if:

• Patients under the age of 18 years old
• Pregnant women
• Patient with serious arrhythmia
• Patient with preeclamptic
• Patient who cannot speak/read English.
• Patients using University Hospital or other clinical offices as their primary care service

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Peijia Zha

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

1,Low SES, urban environment cased small sample size.2,medication for some comorbidities may cause blood pressure decrease. We did not consider other comorbidities among the participants in this study, the results should be interpreted with caution.

Results Point of Contact

• Title: Dr. Peijia Zha
• Organization: School of Nursing, Rutgers, the State University of New Jersey

peijiaz@sn.rutgers.edu

7327637412

Study Officials

• Peijia Zha, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 17, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)