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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Peijia Zha, PhD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peijia Zha | Newark | New Jersey | 07101 | United States |
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We have total 30 participants enrolled in the study, there was no significant events occurred before they were assigned to groups.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. Vi |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
30 participants were randomly assigned in the mHealth group and the standard follow-up group. 15 in each group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | the Standard Follow-up Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All study sample were analyzed. | Posted | Mean | Standard Deviation | mm Hg | baseline, 3 monthly intervals over 6 months of follow up |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | the mHealth Group | The mHealth group asked to use iHealth BP7-Wirless 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peijia Zha | School of Nursing, Rutgers, the State University of New Jersey | 7327637412 | peijiaz@sn.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2018 | Feb 8, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2018 | Feb 8, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| 6 months |
| baseline and 6-month |
| 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. | baseline and 6-month |
| 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. | 6 months |
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 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Count of Participants | Participants |
|
| Region of Enrollment | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Count of Participants | Participants |
|
| Blood Pressure (BP) | At the baseline, all study participants' blood pressure were measured in an upright seated position with feet flat on the floor while being at rest for at least 5 minutes. 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. An average of the BP readings recorded. | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Mean | Standard Deviation | mm Hg |
|
| Health-Related Quality of Life | Health-Related Quality of Life were measured by 36-Item Short Form Health Survey (SF-36). SF-36 consisted of the sum scores of eight subscales(physical functioning, physical role limitations, mental health, emotional role limitations, social functioning, vitality, pain, general health perceptions), which are the weighted sums of the questions. 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. | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Mean | Standard Deviation | units on a scale |
|
| 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 | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Mean | Standard Deviation | units on a scale |
|
| Hospital Admissions for Hypertension Related Illnesses | Data obtained from patients' electronic health records. Total number of hospital admissions for hypertension related illnesses were recorded. | Three participants in the mHealth group withdrew the study, two participants in the standard follow-up group lost follow up. The final analysis included 25 participants. | Number | hosptial Admissions |
|
| OG000 | 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. |
| OG001 | 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 |
|
|
| 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). | All study sample were analyzed. | Posted | Number | adherence | 6 months |
|
|
|
| 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 | All study sample data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6-month |
|
|
|
| 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. | All study sample were analyzed. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6-month |
|
|
|
| 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. | All study sample were analyzed | Posted | Number | hospital admissions | 6 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mental component summary_Baseline |
|
| Mental component summary_6-month |
|