Trial Outcomes & Findings for Effect of Smart Phone Based Telemonitoring on Blood Pressure Among Hypertensive Patients in Primary Care (NCT NCT02046993)

Results Overview

Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

210 participants

Primary outcome timeframe

Baseline, 3rd month, 6th month

Results posted on

2016-12-12

Participant Flow

recruitment of eligible subjects from January to December 2014 at a primary care clinic in Hong Kong

Participant milestones

Participant milestones
Measure	Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Enahnced Usual Care Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
Overall Study STARTED	105	105
Overall Study 3rd Month	104	97
Overall Study 6th Month	102	94
Overall Study COMPLETED	102	94
Overall Study NOT COMPLETED	3	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Enahnced Usual Care Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
Overall Study Withdrawal by Subject	2	10
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Effect of Smart Phone Based Telemonitoring on Blood Pressure Among Hypertensive Patients in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smart Phone Based Telemonitoring of HBP n=105 Participants Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Usual Care n=105 Participants Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary	Total n=210 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 8.7 • n=5 Participants	59.4 years STANDARD_DEVIATION 8.9 • n=7 Participants	58.3 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	105 Participants n=5 Participants	105 Participants n=7 Participants	210 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Hong Kong	105 participants n=5 Participants	105 participants n=7 Participants	210 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3rd month, 6th month

Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week

Outcome measures

Outcome measures
Measure	Smart Phone Based Telemonitoring of HBP n=105 Participants Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Enhanced Usual Care n=105 Participants Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
Percentage of Subjects Doing Home BP Monitoring baseline	54 percentage of subjects doing HBPM	46 percentage of subjects doing HBPM
Percentage of Subjects Doing Home BP Monitoring 3rd month	68 percentage of subjects doing HBPM	64 percentage of subjects doing HBPM
Percentage of Subjects Doing Home BP Monitoring 6th month	67 percentage of subjects doing HBPM	62 percentage of subjects doing HBPM

PRIMARY outcome

Timeframe: baseline, 3rd month and 6 month

Population: Intention to treat analysis was used and the last known data were carried forward to replace missing values for drop-outs.

At baseline and follow-up visits, research assistants who are blinded to allocation outcomes will meaure blood pressure after 15 minutes rest with validated electronic automated sphygmanometer ( ) . Four blood pressure readings taken at 1 minute interval will done for each subject and the mean of the second and third reading would be used for the primary outcome ,

Outcome measures

Outcome measures
Measure	Smart Phone Based Telemonitoring of HBP n=105 Participants Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Enhanced Usual Care n=105 Participants Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline baseline mCSBP in mmHg	129.96 mmHg Standard Deviation 11.86	130.40 mmHg Standard Deviation 14.74
Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline baseline mCDBPin mmHg	81.19 mmHg Standard Deviation 8.49	81.41 mmHg Standard Deviation 10.12
Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline change mCSBPat 3 months	-2.22 mmHg Standard Deviation 15.3	-3.28 mmHg Standard Deviation 13.9
Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline change in mCDBP at 3 months	-2.42 mmHg Standard Deviation 7.4	-0.82 mmHg Standard Deviation 8.8
Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline change mCSBP 6 months from baseline	-1.10 mmHg Standard Deviation 13.1	-2.82 mmHg Standard Deviation 14.4
Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline change mCDBPat 6 months from baseline	-1.35 mmHg Standard Deviation 6.2	-1.52 mmHg Standard Deviation 8.7

PRIMARY outcome

Timeframe: baseline

Population: The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected

At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.

Outcome measures

Outcome measures
Measure	Smart Phone Based Telemonitoring of HBP n=93 Participants Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Enhanced Usual Care n=79 Participants Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline baseline HDBPin mmHg	77.16 mmHg Standard Deviation 8.13	77.32 mmHg Standard Deviation 8.31
Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline baseline HSBP in mmHg	127.17 mmHg Standard Deviation 11.08	128.35 mmHg Standard Deviation 13.53

PRIMARY outcome

Timeframe: 3 months

Population: The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected

At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.

Outcome measures

Outcome measures
Measure	Smart Phone Based Telemonitoring of HBP n=104 Participants Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Enhanced Usual Care n=97 Participants Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings at 3 Months Between Smart Phone Based Telemonitoring Group and Control Group on Enhanced Usual Care 3 months HSBP in mmHg	121.50 mmHg Standard Deviation 11.17	124.37 mmHg Standard Deviation 10
Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings at 3 Months Between Smart Phone Based Telemonitoring Group and Control Group on Enhanced Usual Care 3 months HDBPin mmHg	73.93 mmHg Standard Deviation 7.24	74.97 mmHg Standard Deviation 7.91

PRIMARY outcome

Timeframe: 6 months

Population: The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected

At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.

Outcome measures

Outcome measures
Measure	Smart Phone Based Telemonitoring of HBP n=102 Participants Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Enhanced Usual Care n=94 Participants Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
Comparison Between Mean Home Systolic and Diastolic Blood Pressure HSBP and HDBP Readings at 6 Months Between the Smartphone Based Telemonitoring Group and Control Group on Enhanced Usual Care mHSBP in mmHg at 6 months between groups	122.63 mmHg Standard Deviation 11.1	124.95 mmHg Standard Deviation 11.25
Comparison Between Mean Home Systolic and Diastolic Blood Pressure HSBP and HDBP Readings at 6 Months Between the Smartphone Based Telemonitoring Group and Control Group on Enhanced Usual Care mHDBPin mmHg at 6 months between groups	74.15 mmHg Standard Deviation 8.23	75.87 mmHg Standard Deviation 7.59

SECONDARY outcome

Timeframe: 6 months

This is a 6-items scale for measuring confidence of patients in self management of their chronic disease. Each item has a likert scale from 1 to 10 with 10 as most confident. Higher score indicating higher self-efficacy

Outcome measures

Outcome measures
Measure	Smart Phone Based Telemonitoring of HBP n=105 Participants Smart phone based telemonitoring home blood pressure (HBP) 1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly	Hypertensive Patients on Enhanced Usual Care n=105 Participants Hypertensive patients on usual care 1. . Patients to do HBP measurement 2. . Record BP readings in their diary Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention 6 months SEMCD from baseline between groups	38.75 units on a scale Standard Deviation 10.92	37.74 units on a scale Standard Deviation 11.36
Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention baseline SEMCD between groups	37.72 units on a scale Standard Deviation 11.59	38.10 units on a scale Standard Deviation 11.85
Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention 3 months SEMCD from Baseline between groups	39.99 units on a scale Standard Deviation 10.07	38.96 units on a scale Standard Deviation 10.43

Adverse Events

Smart Phone Based Telemonitoring of HBP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Usual Care

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 Lorna Ng

Kwong Wah Hospital

Phone: (852) 23322311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place