Trial Outcomes & Findings for Improve Hypertension Monitoring and Self-management by Using mHealth (NCT NCT02632838)

Last Updated: 2018-06-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

baseline, 3 monthly intervals over 6 months of follow up

Results posted on

2018-06-19

Participant Flow

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.

We have total 30 participants enrolled in the study, there was no significant events occurred before they were assigned to groups.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	15	15
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Withdrawal by Subject	3	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

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.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: baseline, 3 monthly intervals over 6 months of follow up

Population: All study sample were analyzed.

Outcome measures

Outcome measures
Measure	the mHealth Group n=12 Participants 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.	the Standard Follow-up Group n=13 Participants 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
Blood Pressure (BP) Change Systolic BP_Baseline	145.77 mm Hg Standard Deviation 5.1	145.67 mm Hg Standard Deviation 3.68
Blood Pressure (BP) Change Systolic BP_3-month	140.55 mm Hg Standard Deviation 5.46	142.62 mm Hg Standard Deviation 5.69
Blood Pressure (BP) Change Systolic BP_6-month	137.38 mm Hg Standard Deviation 4.86	140.88 mm Hg Standard Deviation 5.01
Blood Pressure (BP) Change Diastolic BP_Baseline	90.84 mm Hg Standard Deviation 7.58	90.30 mm Hg Standard Deviation 6.46
Blood Pressure (BP) Change Diastolic BP_3-month	90.53 mm Hg Standard Deviation 7.62	88.95 mm Hg Standard Deviation 9.02
Blood Pressure (BP) Change Diastolic BP_6-month	88.08 mm Hg Standard Deviation 7.45	88.10 mm Hg Standard Deviation 9.41

SECONDARY outcome

Timeframe: 6 months

Population: All study sample were analyzed.

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).

Outcome measures

Outcome measures
Measure	the mHealth Group n=12 Participants 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.	the Standard Follow-up Group n=13 Participants 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
Blood Pressure Monitoring Adherence	0.71 adherence	0.65 adherence

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 6-month

Population: All study sample data were analyzed.

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

Outcome measures

Outcome measures
Measure	the mHealth Group n=12 Participants 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.	the Standard Follow-up Group n=13 Participants 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
Health-Related Quality of Life Physical component summary_Baseline	41.22 units on a scale Standard Deviation 8.91	40.19 units on a scale Standard Deviation 10.85
Health-Related Quality of Life Physical component summary_6-month	42.63 units on a scale Standard Deviation 11.21	44.25 units on a scale Standard Deviation 11.17
Health-Related Quality of Life Mental component summary_Baseline	42.16 units on a scale Standard Deviation 10.79	48.73 units on a scale Standard Deviation 10.26
Health-Related Quality of Life Mental component summary_6-month	43.11 units on a scale Standard Deviation 10.23	49.65 units on a scale Standard Deviation 11.87

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 6-month

Population: All study sample were analyzed.

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.

Outcome measures

Outcome measures
Measure	the mHealth Group n=12 Participants 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.	the Standard Follow-up Group n=13 Participants 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
Patient Self-efficacy Baseline	64.85 units on a scale Standard Deviation 10.85	64.75 units on a scale Standard Deviation 11.44
Patient Self-efficacy 6-month	69.17 units on a scale Standard Deviation 7.77	61 units on a scale Standard Deviation 13.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All study sample were analyzed

Data obtained from patients' electronic health records. Total number of hospital admissions for hypertension related illnesses were compared at baseline and 6 months.

Outcome measures

Outcome measures
Measure	the mHealth Group n=12 Participants 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.	the Standard Follow-up Group n=13 Participants 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
Hospital Admissions for Hypertension Related Illnesses	4 hospital admissions	5 hospital admissions

Adverse Events

the mHealth Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

the Standard Follow-up Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peijia Zha

School of Nursing, Rutgers, the State University of New Jersey

Phone: 7327637412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	the mHealth Group n=15 Participants 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.	the Standard Follow-up Group n=15 Participants 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	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants • 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.	0 Participants n=13 Participants • 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.	0 Participants n=25 Participants • 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.
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants • 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.	13 Participants n=13 Participants • 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.	25 Participants n=25 Participants • 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.
Age, Categorical >=65 years	0 Participants n=12 Participants • 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.	0 Participants n=13 Participants • 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.	0 Participants n=25 Participants • 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.
Age, Continuous	48.9 years STANDARD_DEVIATION 8 • n=12 Participants • 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.	55.5 years STANDARD_DEVIATION 5.2 • n=13 Participants • 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.	52.4 years STANDARD_DEVIATION 7.4 • n=25 Participants • 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.
Sex: Female, Male Female	12 Participants n=12 Participants • 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.	12 Participants n=13 Participants • 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.	24 Participants n=25 Participants • 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.
Sex: Female, Male Male	0 Participants n=12 Participants • 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.	1 Participants n=13 Participants • 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.	1 Participants n=25 Participants • 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.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=12 Participants • 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.	1 Participants n=13 Participants • 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.	1 Participants n=25 Participants • 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.
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=12 Participants • 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.	12 Participants n=13 Participants • 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.	24 Participants n=25 Participants • 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.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants • 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.	0 Participants n=13 Participants • 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.	0 Participants n=25 Participants • 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.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=12 Participants • 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.	0 Participants n=13 Participants • 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.	0 Participants n=25 Participants • 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.
Race (NIH/OMB) Asian	0 Participants n=12 Participants • 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.	0 Participants n=13 Participants • 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.	0 Participants n=25 Participants • 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.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants • 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.	0 Participants n=13 Participants • 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.	0 Participants n=25 Participants • 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.
Race (NIH/OMB) Black or African American	12 Participants n=12 Participants • 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.	12 Participants n=13 Participants • 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.	24 Participants n=25 Participants • 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.
Race (NIH/OMB) White	0 Participants n=12 Participants • 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.	1 Participants n=13 Participants • 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.	1 Participants n=25 Participants • 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.
Race (NIH/OMB) More than one race	0 Participants n=12 Participants • 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.	0 Participants n=13 Participants • 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.	0 Participants n=25 Participants • 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.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants • 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.	0 Participants n=13 Participants • 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.	0 Participants n=25 Participants • 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.
Region of Enrollment United States	12 Participants n=12 Participants • 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.	13 Participants n=13 Participants • 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.	25 Participants n=25 Participants • 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.
Blood Pressure (BP) Systolic BP_Baseline	145.77 mm Hg STANDARD_DEVIATION 5.10 • n=12 Participants • 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.	145.67 mm Hg STANDARD_DEVIATION 3.68 • n=13 Participants • 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.	145.72 mm Hg STANDARD_DEVIATION 4.32 • n=25 Participants • 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.
Blood Pressure (BP) Diastolic BP_Baseline	90.48 mm Hg STANDARD_DEVIATION 7.58 • n=12 Participants • 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.	90.30 mm Hg STANDARD_DEVIATION 6.46 • n=13 Participants • 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.	90.39 mm Hg STANDARD_DEVIATION 7.09 • n=25 Participants • 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.
Health-Related Quality of Life Physicalcomponent summary_Baseline	41.22 units on a scale STANDARD_DEVIATION 8.91 • n=12 Participants • 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.	40.19 units on a scale STANDARD_DEVIATION 10.85 • n=13 Participants • 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.	40.69 units on a scale STANDARD_DEVIATION 9.77 • n=25 Participants • 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.
Health-Related Quality of Life Mental compent summary_Baseline	42.16 units on a scale STANDARD_DEVIATION 10.79 • n=12 Participants • 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.	48.73 units on a scale STANDARD_DEVIATION 10.26 • n=13 Participants • 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.	45.58 units on a scale STANDARD_DEVIATION 10.83 • n=25 Participants • 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.
Patient Self-efficacy	64.75 units on a scale STANDARD_DEVIATION 10.85 • n=12 Participants • 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.	64.85 units on a scale STANDARD_DEVIATION 11.44 • n=13 Participants • 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.	64.80 units on a scale STANDARD_DEVIATION 10.92 • n=25 Participants • 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.
Hospital Admissions for Hypertension Related Illnesses	3 hosptial Admissions n=12 Participants • 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.	1 hosptial Admissions n=13 Participants • 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.	4 hosptial Admissions n=25 Participants • 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.