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| ID | Type | Description | Link |
|---|---|---|---|
| HKCFPRFG2013 | Other Identifier | HKCFP Research Fellowship Grant 2013 |
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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 patients receiving enhanced usual care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart phone based telemonitoring of HBP | Experimental |
|
|
| Enhanced usual care | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart phone telemonitoring HBP + enhanced usual care | Behavioral | Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 , | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients could not use the smart phone independently, such as mentally or physically incapacitated.
Patients are not competent in verbal or written communication.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kwong Wah Hospital General Out-Patient and Family Medicine Department | Hong Kong | Kowloon, Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23550251 | Background | 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. |
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recruitment of eligible subjects from January to December 2014 at a primary care clinic in Hong Kong
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| ID | Title | Description |
|---|---|---|
| FG000 | Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care | Smart phone based telemonitoring home blood pressure (HBP)
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 |
| FG001 | Hypertensive Patients on Enahnced Usual Care | Hypertensive patients on usual care
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Smart Phone Based Telemonitoring of HBP | Smart phone based telemonitoring home blood pressure (HBP)
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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | Posted | Number | percentage of subjects doing HBPM | Baseline, 3rd month, 6th month |
|
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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 | Smart Phone Based Telemonitoring of HBP |
Smart phone telemonitoring HBP + enhanced usual care: Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lorna Ng | Kwong Wah Hospital | (852) 23322311 | ngl@ha.org.hk |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Enhanced usual care | Behavioral | Encouraged to do HBP measurement and record BP readings in paper diary |
|
| 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. | 6 months |
| BG001 | Hypertensive Patients on Usual Care | Hypertensive patients on usual care
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Hypertensive patients on usual care
Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary
|
|
|
| Primary | 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 , | Intention to treat analysis was used and the last known data were carried forward to replace missing values for drop-outs. | Posted | Mean | Standard Deviation | mmHg | baseline, 3rd month and 6 month |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | mmHg | baseline |
|
|
|
|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | mmHg | 3 months |
|
|
|
|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | Enhanced Usual Care |
Enhanced usual care: Encouraged to do HBP measurement and record BP readings in paper diary | 0 | 105 | 0 | 105 |
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| change mCSBPat 3 months |
|
| change in mCDBP at 3 months |
|
| change mCSBP 6 months from baseline |
|
| change mCDBPat 6 months from baseline |
|
| t-test, 2 sided |
| 0.865 |
| No |
| Superiority or Other |
| Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 3 months from baseline | t-test, 2 sided | 0.476 | No | Superiority or Other |
| Comparison of difference of mean clinic diastolic BP mCDBP readings between control and intervention at 3 months from baseline | t-test, 2 sided | 0.14 | No | Superiority or Other |
| Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 6 months from baseline | t-test, 2 sided | 0.495 | No | Superiority or Other |
| Comparison of difference in mean clinic diastolic BP readings mCDBP between control and intervention at 6 months from baseline | t-test, 2 sided | 0.967 | No | Superiority or Other |
| 6 months SEMCD from baseline between groups |
|
| t-test, 2 sided |
| 0.512 |
| No |
| Superiority or Other |
| Comparison of SEMCD at 6 months between telemonitoring group and enhanced usual care group | t-test, 2 sided | 0.325 | No | Superiority or Other |
| t-test, 2 sided |
| 0.902 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| 0.204 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| 0.204 |
| No |
| Superiority or Other |