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

Study Overview
=================
Brief 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 patients receiving enhanced usual care.

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.

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

Conditions
-----------------
Hypertension, Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: Smart phone telemonitoring HBP + enhanced usual care
* Behavioral: Enhanced usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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. -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart phone based telemonitoring of HBP<br>. Patients do HBP monitoring . record their BP readings into the smart phone with downloaded application. | Behavioral: Smart phone telemonitoring HBP + enhanced usual care<br>* Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary<br>Behavioral: Enhanced usual care<br>* Encouraged to do HBP measurement and record BP readings in paper diary<br>|
| Active Comparator: Enhanced usual care<br>. Patients to do HBP measurement . Record BP readings in their diary | Behavioral: Smart phone telemonitoring HBP + enhanced usual care<br>* Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary<br>Behavioral: Enhanced usual care<br>* Encouraged to do HBP measurement and record BP readings in paper diary<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smartphone based telemonitoring, primary care, Hypertension, self blood pressure monitoring