HypertensionNCT02046993

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

A study of Hypertension and Blood Pressure, run by Kwong Wah Hospital at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To test the hypothesis that hypertensive patients who participate in smart phone based telemonitoring of BP will conduct more home blood pressure monitoring, better self management behavior and greater reduction in blood pressure and better self management behaviour from baseline to 6 months follow up than those… Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Hypertension, Blood Pressure
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 1 siteHong Kong
Study dates: Jan 2014to Mar 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All hypertensive patients aged 30 or above and using smart phone
Agrees to participate in this pilot study
required to attend structured HBPM education program and assessed competent in self BP measurement

Who cannot join

Patients could not use the smart phone independently, such as mentally or physically incapacitated.
Patients are not competent in verbal or written communication.
-

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Kwong Wah Hospital General Out-Patient and Family Medicine Department
Hong Kong, Kowloon, Hong Kong

Other trials in Hong Kong

About this study

Read the detailed description

A prospective, block randomized controlled 6 months study comparing the blood pressure control of hypertensive patients who participate in enhanced usual care plus smart phone based telemonitoring (TM) of Blood Pressure (BP) to hypertensive patients receiving enhanced usual care (UC) alone in primary care setting.A previous local study done by Fung et al showed a mean diastolic BP reduction of 3.84 mmHg using manual recording of HBPM after structured program. On the basis of the expectation of least 5 mmHg difference with a power of 90% at a significance of level of 5% assuming a standard deviation of 10 mmHg and accounting for 20% attrition rate, a sample size of 206 was needed. Following the inclusion and exclusion criteria, subjects will be recruited on voluntary basis for this study. Having obtained informed consent, all subjects will be required to attend a structured home blood pressure monitoring education program based on Fung et al study and all are required to pass the self-BP measurement competency test before randomisation.[1] All participating subjects will be allocated using block randomization into the intervention group (TM) or control group (UC). Research assistants doing the assessments at baseline, 3 months and 6 months post intervention will be partially blinded to the groupings.At baseline and follow-up visits, research assistants who are blinded to allocation outcomes will measure clinic blood pressure after 15 minutes rest with validated electronic automated sphygmomanometer and conduct the self-efficacy for managing chronic disease scale ( 6-item scale). Four blood pressure readings taken at 1 minute interval will done for each subject and the mean of the 2nd and 3rd readings would be used for the outcome measures at baseline, 3 months and 6 months. For intervention group, patients will be assisted to download a mobile application tool (apps), specifically developed for use in telerecording of readings from home self BP measurement. For the control group, patients will be encouraged on self BP monitoring and keep the BP diary. The research assistants are not blinded in the collection of the mean systolic and diastolic home blood pressure readings readings based on the subjects' paper records for control group or mean systolic and diastolic BP readings sent to the data center at baseline, 3 months and 6 months. Regular home BP monitoring is defined as taking at least 3 or more BP readings per week and documented manually in their paper record or sent electronically through mobile apps to the data center.

Comparisons between these two groups in terms of compliance to home BP measurement and readings,proportion of patients doing home BP monitoring,self-efficacy outcomes and improvement in clinic BP readings at 3 months and 6 months post-intervention will be assessed using statistical analysis.Data analyses were conducted using the Statistical package for the Social Sciences (SPSS) version 16.0. Descriptive statistics, including frequency and percentage for categorical variables and mean and standard deviation for continuous variable, were used to describe the demographic characteristics and summarize baseline characteristics of the variables. Independent T-test was used to examine the differences of outcome variables between TM and UC group. A p-value of 0.05 was used as the level of statistical significance.

The principal investigator and sub-investigator will do regular monitoring, conduct regular meetings with research team to ensure quality assurance in patient recruitment, data collection, data management, data analysis, reporting for adverse events.

Conditions: Hypertension, Blood Pressure
Being tested: Smart phone telemonitoring HBP + enhanced usual care, Enhanced usual care
Keywords: Hypertension, self blood pressure monitoring, smartphone based telemonitoring, primary care
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Smart phone telemonitoring HBP + enhanced usual careBehavioural
Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary
Enhanced usual careBehavioural
Encouraged to do HBP measurement and record BP readings in paper diary

Study groups in NCT02046993
Study group	Role	What they receive
Smart phone based telemonitoring of HBP	Experimental	1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application. Receives: Behavioral: Smart phone telemonitoring HBP + enhanced usual care; Behavioral: Enhanced usual care
Enhanced usual care	Active comparator	1. . Patients to do HBP measurement 2. . Record BP readings in their diary Receives: Behavioral: Smart phone telemonitoring HBP + enhanced usual care; Behavioral: Enhanced usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Doing Home BP Monitoring
Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week
Measured: Baseline, 3rd month, 6th month
Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline
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 ,
Measured: baseline, 3rd month and 6 month
Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline
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.
Measured: baseline
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
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.
Measured: 3 months
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
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.
Measured: 6 months

Secondary outcomes (1)

Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention
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
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Mar 2015

First posted28 Jan 2014 (estimated)
Study startJan 2014
Primary completionDec 2014
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02046993
Sponsor's protocol ID: KW/EX-13-026(60-09)
Other IDs: HKCFPRFG2013
Status last verified: Oct 2016
First submitted: 25 Jan 2014
Last updated: 12 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fung CS, Wong WC, Wong CK, Lee A, Lam CL. Home blood pressure monitoring--a trial on the effect of a structured education program. Aust Fam Physician. 2013 Apr;42(4):233-7.
PubMed 23550251

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Smart Phone Based Telemonitoring on Blood Pressure Among Hypertensive Patients in Primary Care
ClinicalTrials.gov ID: NCT02046993
Acronym / sponsor ID: KW/EX-13-026(60-09)
Conditions: Hypertension, Blood Pressure
Keywords: Hypertension, self blood pressure monitoring, smartphone based telemonitoring, primary care
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: Kwong Wah HospitalUniversity, hospital or other
Study start: Jan 2014
Primary completion: Dec 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 28 Jan 2014 (estimated)
Results: Posted 12 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Smart phone based telemonitoring of HBP	Experimental	Behavioral: Smart phone telemonitoring HBP + enhanced usual care, Behavioral: Enhanced usual care1. . Patients do HBP monitoring 2. . record their BP readings into the smart phone with downloaded application.
Enhanced usual care	Active comparator	Behavioral: Smart phone telemonitoring HBP + enhanced usual care, Behavioral: Enhanced usual care1. . Patients to do HBP measurement 2. . Record BP readings in their diary

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

All hypertensive patients aged 30 or above and using smart phone
Agrees to participate in this pilot study
required to attend structured HBPM education program and assessed competent in self BP measurement

Key exclusion criteria (3 listed)

Patients could not use the smart phone independently, such as mentally or physically incapacitated.
Patients are not competent in verbal or written communication.
-

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Smart phone telemonitoring HBP + enhanced usual careSmart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary	Behavioural	Enhanced usual care, Smart phone based telemonitoring of HBP
Enhanced usual careEncouraged to do HBP measurement and record BP readings in paper diary	Behavioural	Enhanced usual care, Smart phone based telemonitoring of HBP

Primary outcome

Percentage of Subjects Doing Home BP Monitoring
Time frame: Baseline, 3rd month, 6th month
Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week
Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline
Time frame: baseline, 3rd month and 6 month
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 ,
Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline
Time frame: baseline
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.
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
Time frame: 3 months
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.
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
Time frame: 6 months
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.

1 secondary outcome

Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention
Time frame: 6 months

Results and safety

Results posted to the registry on 12 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care	105	102
Hypertensive Patients on Enahnced Usual Care	105	94

Primary outcome: Percentage of Subjects Doing Home BP Monitoring

Time frame: Baseline, 3rd month, 6th month. Number. Unit: percentage of subjects doing HBPM

Measure	Smart Phone Based Telemonitoring of HBP n = 105	Hypertensive Patients on Enhanced Usual Care n = 105
baseline	54	46
3rd month	68	64
6th month	67	62

Smart Phone Based Telemonitoring of HBP vs Hypertensive Patients on Enhanced Usual Care: p = 0.27, Chi-squared
Smart Phone Based Telemonitoring of HBP: p = .020, McNemar
Smart Phone Based Telemonitoring of HBP: p = .060, McNemar

Primary outcome: Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline

Time frame: baseline, 3rd month and 6 month. Mean (Standard Deviation). Unit: mmHg

Measure	Smart Phone Based Telemonitoring of HBP n = 105	Hypertensive Patients on Enhanced Usual Care n = 105
baseline mCSBP in mmHg	129.96 (11.86)	130.40 (14.74)
baseline mCDBPin mmHg	81.19 (8.49)	81.41 (10.12)
change mCSBPat 3 months	-2.22 (15.3)	-3.28 (13.9)
change in mCDBP at 3 months	-2.42 (7.4)	-0.82 (8.8)
change mCSBP 6 months from baseline	-1.10 (13.1)	-2.82 (14.4)
change mCDBPat 6 months from baseline	-1.35 (6.2)	-1.52 (8.7)

Smart Phone Based Telemonitoring of HBP vs Hypertensive Patients on Enhanced Usual Care: p = 0.813, t-test, 2 sided
Smart Phone Based Telemonitoring of HBP vs Hypertensive Patients on Enhanced Usual Care: p = 0.865, t-test, 2 sided
Smart Phone Based Telemonitoring of HBP vs Hypertensive Patients on Enhanced Usual Care: p = 0.476, t-test, 2 sided

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

Primary outcome: Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline

Time frame: baseline. Mean (Standard Deviation). Unit: mmHg

Measure	Smart Phone Based Telemonitoring of HBP n = 93	Hypertensive Patients on Enhanced Usual Care n = 79
baseline HSBP in mmHg	127.17 (11.08)	128.35 (13.53)
baseline HDBPin mmHg	77.16 (8.13)	77.32 (8.31)

Smart Phone Based Telemonitoring of HBP vs Hypertensive Patients on Enhanced Usual Care: p = 0.532, t-test, 2 sided
Smart Phone Based Telemonitoring of HBP vs Hypertensive Patients on Enhanced Usual Care: p = 0.902, t-test, 2 sided

Population analysed: 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

Primary outcome: 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

Time frame: 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	Smart Phone Based Telemonitoring of HBP n = 104	Hypertensive Patients on Enhanced Usual Care n = 97
3 months HSBP in mmHg	121.50 (11.17)	124.37 (10)
3 months HDBPin mmHg	73.93 (7.24)	74.97 (7.91)

Smart Phone Based Telemonitoring of HBP vs Hypertensive Patients on Enhanced Usual Care: p = 0.138, t-test, 2 sided
Smart Phone Based Telemonitoring of HBP vs Hypertensive Patients on Enhanced Usual Care: p = 0.204, t-test, 2 sided

Population analysed: 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

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Smart Phone Based Telemonitoring of HBP	0 of 105 (0%)	0 of 105 (0%)	Not reported
Enhanced Usual Care	0 of 105 (0%)	0 of 105 (0%)	Not reported

Limitations and caveats (from the sponsor): The baseline mean Clinic SBP and DBP as well as the baseline mean home SBP and DBP of both the control and intervention group were already within the optimal range.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23550251Fung CS, Wong WC, Wong CK, Lee A, Lam CL. Home blood pressure monitoring--a trial on the effect of a structured education program. Aust Fam Physician. 2013 Apr;42(4):233-7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Hypertension and Blood Pressure, run by Kwong Wah Hospital at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Doing Home BP Monitoring (time frame: Baseline, 3rd month, 6th month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02046993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.