- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02632838
Improve Hypertension Monitoring and Self-management by Using mHealth
Utilizing a Mobile Health (mHealth) Application to Improve Hypertension Monitoring and Self-management in an Underserved Community: A Pilot Study
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:
- 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.
- Hypertension patients using the mHealth application will exhibit more effective self-management as compared to those who receive standard care.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07101
- Peijia Zha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
No Intervention: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure (BP) Change
Time Frame: baseline, 3 monthly intervals over 6 months of follow up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure Monitoring Adherence
Time Frame: 6 months
|
BP monitoring adherence were used to measure hypertension status monitoring experiences BP monitoring adherence for the mHealth group was 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). BP monitoring adherence for the standard follow-up group was 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). |
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-Related Quality of Life
Time Frame: baseline and 6-month
|
Health-Related Quality of Life were measured by 36-Item Short Form Health Survey (SF-36). The SF-36 consisted of the sum scores of eight subscales (physical functioning, physical role limitations, mental health, emotional role limitations, social functioning, vitality, pain, and general health perceptions), which are the weighted sums of the questions in each sections. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight subscales were summarized into two composite scores (physical and mental quality of life). Various studies demonstrated that the reliability of the SF-36 have exceeded 0.80 The SF-36 scores compared at baseline and 6-month later |
baseline and 6-month
|
Patient Self-efficacy
Time Frame: baseline and 6-month
|
Medication Adherence Self-Efficacy Scale (MASES) were used to measure the patient self-efficacy in adhering to prescribed hypertension medications.
MASES was developed to measure several aspects of self-efficacy, including adherence to prescribed medication for the management of hypertension.
The MASES includes 26 items rated on a 3-point Likert scale (1= Not at all Sure, 2= Somewhat Sure, and 3= Very Sure).
The range of this scale is from 26 to 78.
A total mean score is calculated by averaging responses to all items.
Higher scores indicate a great level of self-efficacy The survey scores compared at baseline and 6 months.
|
baseline and 6-month
|
Hospital Admissions for Hypertension Related Illnesses
Time Frame: 6 months
|
Data obtained from patients' electronic health records.
Total number of hospital admissions for hypertension related illnesses were compared at baseline and 6 months.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peijia Zha, PhD, Rutgers University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro20150001419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
BayerCompletedPrimary HypertensionChina
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on iHealth BP7-Wireless Blood Pressure Wrist Monitor,
-
St. Jude Children's Research HospitalCompleted
-
Huawei Device Co., LtdCompleted
-
University of ArkansasWithdrawn
-
Lawson Health Research InstituteLauren Faught; Michael Greff; Michael Rieder; Safieddin Safavi-NaeiniNot yet recruitingObesity | Fever | Congenital Heart Disease | COPD | Respiratory DistressCanada
-
Icahn School of Medicine at Mount SinaiAT&T and Vital TechSuspended
-
Leo WangBTS InternationalCompletedHypertension | Efficacy of Wrist BPM MeasurementChina
-
Mayo ClinicCompletedHypertension | DiabetesUnited States
-
Cairo UniversityCompletedObesity | Blood PressureEgypt
-
Sheba Medical CenterCompleted
-
National Healthcare Group PolyclinicsMinistry of Health, SingaporeUnknown