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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02046993
Other study ID # KW/EX-13-026(60-09)
Secondary ID HKCFPRFG2013
Status Recruiting
Phase N/A
First received January 25, 2014
Last updated January 27, 2014
Start date January 2014
Est. completion date March 2015

Study information

Verified date January 2014
Source Kwong Wah Hospital
Contact Lorna Ng, MD
Phone (852)35172310
Email ngl@ha.org.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date March 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility Inclusion Criteria:

1. All hypertensive patients aged 30 or above and using smart phone

2. Agrees to participate in this pilot study

3. Competent in self BP measurement

Exclusion Criteria:

1. Patients could not use the smart phone independently, such as mentally or physically incapacitated.

2. Patients are not competent in verbal or written communication.

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
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 patient on usual care
Patient do home BP monitoring Record the Home BP monitoring in their diary

Locations

Country Name City State
Hong Kong Kwong Wah Hospital General Out-Patient and Family Medicine Department Hong Kong Kowloon, Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Kwong Wah Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects doing home BP monitoring Proportion of subjects doing home BP monitoring at least 3 times/week 6 months No
Secondary Systolic and diastolic mean blood pressure readings Subjects' baseline clinic mean blood pressure readings will be compared with clinic mean blood pressure readings at 3 months and 6 months post-intervention 6 months No
Secondary PAM-13 Patient Activation Measure ( PAM-13) The Patient Activation Measure (PAM-13) assessment gauges the knowledge, skills and confidence essential to managing one's own health and healthcare. 6 months No
Secondary Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items). This is a 6-items scale for measuring self efficacy in patients with chronic disease 6 months No
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