Hypertension
Conditions
Keywords
Hypertension, mHealth, underserved community
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.
Interventions
DEVICEiHealth 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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure (BP) Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Monitoring Adherence | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | 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 |
| Patient Self-efficacy | 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. |
| Hospital Admissions for Hypertension Related Illnesses | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited though recruitment flyers, nurses and community health workers (CHWs). Potential participants were invited to attend the information session held by the research team. Informed consent and Health Insurance Portability and Accountability Authorization were obtained for those who were eligible to participate in the study.
Pre-assignment details
We have total 30 participants enrolled in the study, there was no significant events occurred before they were assigned to groups.
Participants by arm
| Arm | Count |
|---|---|
| the mHealth Group The mHealth group asked to use iHealth BP7-Wireless Blood Pressure Wrist Monitor on a daily basis at HOME and also asked to visit community health center once a week to receive the regular hypertension care for the 6-month period as usual. | 15 |
| the Standard Follow-up Group The standard follow-up group received regular hypertension care as usual which consists: nursing assessment, medication management, patient education, follow up and continuing care in the community health center | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Total | the Standard Follow-up Group | the mHealth Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 13 Participants | 12 Participants |
| Age, Continuous | 52.4 years STANDARD_DEVIATION 7.4 | 55.5 years STANDARD_DEVIATION 5.2 | 48.9 years STANDARD_DEVIATION 8 |
| Blood Pressure (BP) Diastolic BP_Baseline | 90.39 mm Hg STANDARD_DEVIATION 7.09 | 90.30 mm Hg STANDARD_DEVIATION 6.46 | 90.48 mm Hg STANDARD_DEVIATION 7.58 |
| Blood Pressure (BP) Systolic BP_Baseline | 145.72 mm Hg STANDARD_DEVIATION 4.32 | 145.67 mm Hg STANDARD_DEVIATION 3.68 | 145.77 mm Hg STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 12 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Health-Related Quality of Life Mental compent summary_Baseline | 45.58 units on a scale STANDARD_DEVIATION 10.83 | 48.73 units on a scale STANDARD_DEVIATION 10.26 | 42.16 units on a scale STANDARD_DEVIATION 10.79 |
| Health-Related Quality of Life Physicalcomponent summary_Baseline | 40.69 units on a scale STANDARD_DEVIATION 9.77 | 40.19 units on a scale STANDARD_DEVIATION 10.85 | 41.22 units on a scale STANDARD_DEVIATION 8.91 |
| Hospital Admissions for Hypertension Related Illnesses | 4 hosptial Admissions | 1 hosptial Admissions | 3 hosptial Admissions |
| Patient Self-efficacy | 64.80 units on a scale STANDARD_DEVIATION 10.92 | 64.85 units on a scale STANDARD_DEVIATION 11.44 | 64.75 units on a scale STANDARD_DEVIATION 10.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 25 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Female | 24 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
Primary
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.
Time frame: baseline, 3 monthly intervals over 6 months of follow up
Population: All study sample were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| the mHealth Group | Blood Pressure (BP) Change | Systolic BP_Baseline | 145.77 mm Hg | Standard Deviation 5.1 |
| the mHealth Group | Blood Pressure (BP) Change | Systolic BP_3-month | 140.55 mm Hg | Standard Deviation 5.46 |
| the mHealth Group | Blood Pressure (BP) Change | Systolic BP_6-month | 137.38 mm Hg | Standard Deviation 4.86 |
| the mHealth Group | Blood Pressure (BP) Change | Diastolic BP_Baseline | 90.84 mm Hg | Standard Deviation 7.58 |
| the mHealth Group | Blood Pressure (BP) Change | Diastolic BP_3-month | 90.53 mm Hg | Standard Deviation 7.62 |
| the mHealth Group | Blood Pressure (BP) Change | Diastolic BP_6-month | 88.08 mm Hg | Standard Deviation 7.45 |
| the Standard Follow-up Group | Blood Pressure (BP) Change | Diastolic BP_3-month | 88.95 mm Hg | Standard Deviation 9.02 |
| the Standard Follow-up Group | Blood Pressure (BP) Change | Systolic BP_Baseline | 145.67 mm Hg | Standard Deviation 3.68 |
| the Standard Follow-up Group | Blood Pressure (BP) Change | Diastolic BP_Baseline | 90.30 mm Hg | Standard Deviation 6.46 |
| the Standard Follow-up Group | Blood Pressure (BP) Change | Systolic BP_3-month | 142.62 mm Hg | Standard Deviation 5.69 |
| the Standard Follow-up Group | Blood Pressure (BP) Change | Diastolic BP_6-month | 88.10 mm Hg | Standard Deviation 9.41 |
| the Standard Follow-up Group | Blood Pressure (BP) Change | Systolic BP_6-month | 140.88 mm Hg | Standard Deviation 5.01 |
Secondary
Blood Pressure Monitoring Adherence
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).
Time frame: 6 months
Population: All study sample were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| the mHealth Group | Blood Pressure Monitoring Adherence | 0.71 adherence |
| the Standard Follow-up Group | Blood Pressure Monitoring Adherence | 0.65 adherence |
Other Pre-specified
Health-Related Quality of Life
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
Time frame: baseline and 6-month
Population: All study sample data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| the mHealth Group | Health-Related Quality of Life | Physical component summary_Baseline | 41.22 units on a scale | Standard Deviation 8.91 |
| the mHealth Group | Health-Related Quality of Life | Physical component summary_6-month | 42.63 units on a scale | Standard Deviation 11.21 |
| the mHealth Group | Health-Related Quality of Life | Mental component summary_Baseline | 42.16 units on a scale | Standard Deviation 10.79 |
| the mHealth Group | Health-Related Quality of Life | Mental component summary_6-month | 43.11 units on a scale | Standard Deviation 10.23 |
| the Standard Follow-up Group | Health-Related Quality of Life | Mental component summary_6-month | 49.65 units on a scale | Standard Deviation 11.87 |
| the Standard Follow-up Group | Health-Related Quality of Life | Physical component summary_Baseline | 40.19 units on a scale | Standard Deviation 10.85 |
| the Standard Follow-up Group | Health-Related Quality of Life | Mental component summary_Baseline | 48.73 units on a scale | Standard Deviation 10.26 |
| the Standard Follow-up Group | Health-Related Quality of Life | Physical component summary_6-month | 44.25 units on a scale | Standard Deviation 11.17 |
Other Pre-specified
Hospital Admissions for Hypertension Related Illnesses
Data obtained from patients' electronic health records. Total number of hospital admissions for hypertension related illnesses were compared at baseline and 6 months.
Time frame: 6 months
Population: All study sample were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| the mHealth Group | Hospital Admissions for Hypertension Related Illnesses | 4 hospital admissions |
| the Standard Follow-up Group | Hospital Admissions for Hypertension Related Illnesses | 5 hospital admissions |
Other Pre-specified
Patient Self-efficacy
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.
Time frame: baseline and 6-month
Population: All study sample were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| the mHealth Group | Patient Self-efficacy | Baseline | 64.85 units on a scale | Standard Deviation 10.85 |
| the mHealth Group | Patient Self-efficacy | 6-month | 69.17 units on a scale | Standard Deviation 7.77 |
| the Standard Follow-up Group | Patient Self-efficacy | Baseline | 64.75 units on a scale | Standard Deviation 11.44 |
| the Standard Follow-up Group | Patient Self-efficacy | 6-month | 61 units on a scale | Standard Deviation 13.08 |