Improve Hypertension Monitoring and Self-management by Using mHealth
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 6/21/2018 |
| Start Date: | January 2016 |
| End Date: | November 2017 |
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:
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.
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.
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.
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.
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
We found this trial at
1
site
