Enhancing the Risk Assessment and Management Program by Promotion of Self-blood Pressure Monitoring

Study Overview
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Brief Summary
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Clinical Trial: The investigators aims at comparing providing validated home BP device, followed by group education of self-management of hypertension as well as self-BP monitoring and appropriate medication in response to home BP reading, followed by nurse follow up with usual care, which may possibly improve patients with uncontrolled hypertensions drug adherence, and therefore improve their BP level in primary care setting. The investigators will invite total 270 patients from 5 general outpatient clinic (GOPCs) to participate the trial. Qualitative study: The investigators would also like to evaluate patients' view and operational concerns on self BP monitoring by individually interviewing 30 selected patients with uncontrolled hypertension

Detailed Description
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Background Recent oversea randomized control trials have proven effectiveness of lowering clinic and home BP if uncontrolled hypertensive patients were taught to perform home BP monitoring properly with validated BP device. Patients were taught to response to home BP reading (e.g. follow drug regime, or doctor adjust drug according to patients' home BP record) Study design 1. Prospective cluster randomized control trial, 2. Qualitative individual interview Aims The investigators aims at comparing providing validated home BP device, followed by group education of self-management of hypertension as well as self-BP monitoring and appropriate medication in response to home BP reading, followed by nurse follow up with usual care, which may possibly improve older adults with uncontrolled hypertension drug adherence, and therefore improve their BP level in a primary care setting. The investigators would also like to evaluate patients' view and operational concerns on self BP monitoring Subjects Adult Chinese on hypertensive treatment more than 12 months with uncontrolled hypertension by mean clinic BP measurement on the day of recruitment. Uncontrolled hypertension is defined as BP > 140/90mmHg in subjects age < 80; and BP > 150/90mmHg in subjects age≥80. You will be invited to participate if you are willing and capable to perform self-home BP monitoring on daily basis. Sample size 270 (45 people from each clinic); 30 people for qualitative interview Assignment 3 clinics will be randomly assigned to intervention clinic while the other 2 will be randomly assigned to the control clinic (usual care) Intervention(s) Doctors and Nurses in intervention clinic will receive 1 hour briefing + education on the background, scientific basis and detail of the program during lunch time. Patients from intervention clinics will be invited to attend 2 x 2 hours education group (15-30 subjects / group) ran by clinic nurses and doctors. You will be educated on basic knowledge, management and drug for hypertension in the first session. In the 2nd session, a certified valid Home BP device will be loaned to you for 6- 9 months and you will be taught to perform home BP monitoring, record and respond to the BP reading accordingly. Upon completion of session 2, you will be arranged for nurse individual follow up after 4-8 weeks to see your progress and monitoring. 30 people with uncontrolled hypertension will be interviewed individually for their opinion on the program, management of hypertension and performance of home BP monitoring. Outcome measures BMI (BH/ BW), Waist circumference, Clinic BP (sitting position/ standing position), Lab Test: FBS, Lipid profile, eGFR, Urine PCR, ECG Qualitative data for patient's view on home BP monitoring Follow up duration 6-18months

Official Title
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A Cluster-randomized Study on the Risk Assessment and Management Program for Home Blood Pressure Monitoring in Population With Inadequate Health Literacy

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Home Blood Presssure Monitoring, Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Chinese on hypertensive treatment uncontrolled hypertension by mean clinic BP measurement on the day of recruitment. Uncontrolled hypertension is defined as BP > 140/90mmHg in subjects age < 80; and BP > 150/90mmHg in subjects age≥80. willing and capable to perform home BP monitoring by themselves on daily basis. - Exclusion Criteria: unable to perform the home monitoring either by themselves mentally incapacitated arrhythmias unstable angina serum creatinine > 250 mmol/l orthostatic hypotension severe left ventricular impairment severe aortic stenosis pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Doctors and Nurses in intervention clinic will receive 1 hour briefing + education on the background, scientific basis and detail of the program during lunch time. People from intervention clinics will be invited to attend 2 x 2 hours education group (15-30 subjects / group) ran by clinic nurses and doctors. You will be educated on basic knowledge, management and drug for hypertension in the first session. In the 2nd session, a certified valid Home BP device will be loaned to you for 6-9 months and you will be taught to perform home Blood pressure monitoring, record and response to the BP reading accordingly. Upon completion of session 2, you will be arranged for nurse individual follow up after 4-8 weeks to see their progress and monitoring | Behavioral: Home Blood Presssure Monitoring, Education<br>* Doctors and Nurses in intervention clinic will receive 1 hour briefing + education on the background, scientific basis and detail of the program during lunch time. People from intervention clinics will be invited to attend 2 x 2 hours education group (15-30 subjects / group) ran by clinic nurses and doctors. You will be educated on basic knowledge, management and drug for hypertension in the first session. In the 2nd session, a certified valid Home BP device will be loaned to you for 6-9 months and you will be taught to perform home BP monitoring, record and response to the BP reading accordingly. Upon completion of session 2, you will be arranged for nurse individual follow up after 4-8 weeks to see their progress and monitoring<br>* Other names: HBPM;|
| No Intervention: Control Group<br>Usual Care of hypertension in primary care clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinic Blood Pressure control rate | After 18 months of treatment, to compare BP control rate in the intervention group and the control group. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with normal body mass index | To compare the BW and BMI over time | 18 months | 
| Change of fasting blood sugar level | To compare the fasting blood sugar level over time | 18 months | 
| Change of low density lipoprotein level (LDL) | To compare the low density lipoprotein level (LDL) over time | 18 months | 
| Change in mean clinic Systolic blood pressure (SBP) intervention group when compare with control group | To comparer the SBP level over time | 6 months, 12 months and 18 months | 
| Change in mean clinic diastolic blood pressure DBP intervention group when compare with control group | To compare intervention group when compared with control group | 6 months, 12 months and 18 months | 
| Qualitative study of patients' view and experience of home blood pressure monitoring | Patients' experience were report in the framework of the social cognitive theory | 5 patients are interviewed before intervention, 6 weeks post-intervention, different time frame after patients' hypertension diagnosed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Blood Pressure Monitoring, Health literacy, Blood Pressure control