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

Hypertension Clinical Trial

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

Status Recruiting

Clinical 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 patients receiving usual care.

Clinical Trial Description

A prospective, block randomized controlled 6 months study comparing the blood pressure control of hypertensive patients who participate in usual care plus smart phone based telemonitoring (TM) of BP to hypertensive patients receiving usual care (UC) alone in primary care setting. Following the inclusion and exclusion criteria, subjects will be recruited on voluntary basis for this study. The investigators plan to recruit 160 subjects based on our previous findings, 48% of hypertensive patients had recorded home blood pressure (BP) readings and only 14% of patients would present the BP record to doctors while on follow up, the investigators expect the rate will increase the rate to around 40% with the intervention. Therefore, for detecting the difference with 5% level of significance and 80% of power, a sample size of 57 is needed at each comparison group. With attrition rate of 30%, 80 patients will be allocated to each group.

Having obtained informed consent, all subjects will be required to attend a hypertension workshop which includes overview of the disease, importance and benefits of self BP monitoring as well as teaching of correct techniques of BP measurement. All participants are required to pass the assessment on self BP measurement facilitated by trained research assistants, supervised by nurses or doctors. 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 blinded to the groupings.At baseline and follow-up visits, research assistants who are blinded to allocation outcomes will measure blood pressure after 15 minutes rest with validated electronic automated sphygmomanometer. 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. 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.

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. Paired T-test was performed to examine the differences of outcome measures before and after intervention program within group. Analysis of variance (ANOVA) is 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

• NCT number: NCT02046993
• Study type: Interventional
• Source: Kwong Wah Hospital
• Contact: Lorna Ng, MD
• Phone: (852)35172310
• Email: ngl@ha.org.hk
• Status: Recruiting
• Phase: N/A
• Start date: January 2014
• Completion date: March 2015