A Cluster-randomized Study on the Risk Assessment and Management Program for Home Blood Pressure Monitoring in Population With Inadequate Health Literacy
Phase: NA
Conditions: Hypertension
Sponsor: The University of Hong Kong

 
 
3-Jan-2016 
Enhance Home Blood Pressure Monitoring Accuracy in uncontrolled 
Hypertension: a Randomized Controlled Trial 
Background: 
Being a highly prevalence global health problem, high blood pressure (BP) attributed to 13.5% of 
the global total premature death (1).Clinical findings in Hong Kong were shown to be comparable 
to the global situation. Locally, hypertension is the commonest chronic disease in Hong Kong with 
a prevalence of 27% among people aged 15 years or above.(2) It is the second commonest reason 
for consultation in Hong Kong primary care setting.(3) Control of BP to an optimal level is 
recommended to prevent irreversible cardiovascular event.  
International guidelines including the European Society of Hypertension (EHS) (4), National 
Institute for Health and Clinical Excellence (NICE)(5) and the World Hypertension League(6) 
recommended appropriate use of home blood pressure monitoring (HBPM) in evaluate 
hypertension in certain clinical conditions.  Systemic reviews have shown HBPM improve patients’ 
BP control rate and compliance with treatment. (7,8)  HBPM enables a more precise initial 
diagnosis of hypertension and more accurate titration of antihypertensive drug treatment (4), as 
shown by randomized control trials (9-12). Current Evidence suggested that blood pressure (BP) 
assessment are frequently inaccurate, with a high potential to misdiagnose a large segment of the 
population. (13). Therefore, the use of automated devices using oscillometry  is recommended 
for HBPM (4).  
As response to the recent promulgation by primary care clinicians (14), many patients with 
hypertension adopt HBPM (15).  Local study also showed short term improvement of BP by one-
off structured education program of home BP monitoring (16).  However,   sustainability of high 
quality HBPM technique remains unknown. 
High quality HBPM depends on selection of validated device according to international 
recommendation; appropriate cuff size; conditions of measurement, correct procedure of 
measurement; and correct interpretation of HBPM readings.(4) Even with training, the use of 
standardized manual techniques(17) delcines rapidly without regular retraining and accuracy 
testing(6). The accuracy of monitors and operators was prone to error, mostly due to mistakes by 
operator.(18) 
 
Therefore, we propose to provide structural group educations focus on accurate BP measurement, 
provided with validated home BP device, with regular reassessment of BP measurement 
technique.  We are interested to find out whether the proposed intervention can lower BP and 
sustain high quality HBPM. 
 
 

 
 
3-Jan-2016 
Study  Aims and Objectives:  
We aims at comparing providing validated home BP device, followed by group education of self-
BP monitoring and regular assessment accuracy of BP monitoring, which may possibly improve BP 
control rate of patients with uncontrolled hypertensions in primary care setting.  We would also 
like to evaluate whether the quality of BP measurement is sustainable, any change in biochemical 
markers, clinic BP readings in 6 months, 12 months and 18 months interval. We would also find 
out patients’ view on home BP monitoring and the education program. 
Research Questions 
1. Do the people with uncontrolled BP have higher control rate after provision of validated 
BP device followed by education and assessment of BP measurement technique? 
2. Are there improvements in the clinic BP body weight, BMI, biochemical markers followed 
by the HBPM education program? 
3. Can quality of HBPM be sustainable by education followed by regular reassessment? 
4. What is patients’ view on HBPM? 
Methods 
We adopt prospective longitudinal randomized control trial. Subjects from four general 
outpatient clinics (GOPCs) located in urban residential area will be involved in the study.   
Study Practices and randomization procedure 
We aimed to determine the effectiveness of HBPM education and provision of validated home BP 
device. Since the intervention involve doctors, nurses and patient cooperation, cluster (using one 
clinic as one cluster) approach is utilized to minimize risk of treatment contamination.  Three 
clinics are randomly assigned as intervention clinic and the other three will be assigned as usual 
care clinic. (Appendix 1) To avoid contamination, separate protocols will be sent to individual 
clinics assigned to intervention and control.   The Research helper will assist subject recruitment 
and data collection.  The measurements and lab test will be performed by local clinic nurses and 
doctors in control clinics. 
Research Subjects Recruitment 
The recruitment of subjects and study workflow is shown in Figure 1.  We include adult subjects 
aged above 18 years old on hypertensive treatment more than 12 months with uncontrolled 
hypertension and no previous HBPM on the day of recruitment.  Uncontrolled hypertension is 
defined as BP > 140/90mmHg(19,20) in subjects age < 80; and BP > 150/90mmHg(21) in subjects 
age≥80. They will be invited to participate if they are willing and capable to perform home BP 
monitoring by themselves on daily basis.  Appropriate subjects will be identified during doctor 
consultation and nurse consultations and subjects will be invited after normal consultation.  

 
 
3-Jan-2016 
We exclude subjects who are unable to perform the home monitoring either by themselves; or 
have arrhythmias, unstable angina, serum creatinine > 250 mmol/l, orthostatic hypotension, 
severe left ventricular impairment, severe aortic stenosis and pregnancy. 
Data Collection 
Subjects enrollment and baseline assessment take place before randomization.  Follow up data 
collection will be conducted 6 months, 12 months and 18 months after intervention. 
Baseline Assessment 
At baseline, patient age, sex, smoking habits, body mass index, waist circumference, education 
level, occupation, payment method, household income and number of household family 
members, health literacy by Chinese Health Literacy Scale for Chronic Care (22)will be collected 
via questionnaires by clinic nurses and research helper.  Medical history includes diabetes mellitus,  
nephropathy, manifest cardiovascular disease (namely ischaemic heart disease, cerebral vascular 
disease, and peripheral vascular disease), current medication including antihypertensives drugs, 
lipid lowering agents, and antiplatelet drugs, laboratory test results including fasting blood sugar, 
glycemic haemoglobin level, lipid profile, serum creatinine level, presence of significant 
proteinuria will be collected by investigators via computerized patient record. 
Baseline blood pressure will be measured in clinic 3 times after taking at least 5 minutes rest in a 
sitting position by Ormon HEM-907 clinic use BP device  (passed International Protocol of the 
European Society of Hypertension for elderly)(23); with an appropriately sized cuff in the right 
arm, which is accredited model by British Hypertension society.  The BP will be taken at least one 
hour after the subject’s last meal and at least 30 minutes after smoking or consumption of a 
caffeinated beverage. The systolic and diastolic blood pressure will be measured 3 times and we 
will take the mean of the second 2 out of 3 office reading each time).    
 
For safety considerations, if any BP measurements were above 170 mmHg systolic or 105 mmHg 
diastolic, the BP were rechecked again 5 minutes later. If the BP remained above these levels, the 
result will alert attending physicians for further management. 
 
 
Usual Care (Control Group) 
All subjects see their physicians and / or nurse for routine BP measurement and /or adjust 
medication at the discretion of the health professional.  They received nurse individual counselling 
explained management of uncontrolled hypertension in patients’ understandable language will 
be arranged as routine practice. 
 
Intervention Group 
1. Two 2 hours Training sessions (by nurses/ doctors ) 
All subjects will attend a 2 hours training in the education room of study clinics.  There will be 15 
to 30 subjects in each education group, depends on size of venue. 

 
 
3-Jan-2016 
Nurses or doctors will brief subjects about basic hypertension medical knowledge, lifestyle 
modifications and hypertensive complications for 30 minutes.  Automated Brachial type home BP 
device  AND UA651 (Appendix 5) will be loaned to subjects up to 3 months. 
It follows by 1 hour interactive seminar 
1. Select appropriate cuff size by nurses 
2. Stepwise education on home BP monitoring procedure  
3. Standard Home BP Record Hand Book (Appendix 6). 
4. Method of recording 
Finally, it will be demonstration of assessment of the HBPM procedure. (Appendix 7)  All subjects 
will undergo the same assessment when they return the BP device. 
2. Next scheduled clinic visit (1-3 months after Training Session 
• 
In the next doctor consultation (within 12 weeks of education talk), BP device will be 
returned 
• 
Clinic nurses will assess the self-monitoring technique, home BP records , body weight 
and BMI and the clinic BP levels 
3. 6 months, 12 months and 18 months post intervention 
Clinic nurses will assess the self-monitoring technique, home BP records, body weight and BMI 
and the clinic BP levels 
4. 18 months post intervention 
The above measurement will be collected via questionnaires by clinic nurses and research helper.  
Medical history includes diabetes mellitus, manifest cardiovascular disease (namely ischaemic 
heart disease, cerebral vascular disease, and peripheral vascular disease), current medication 
including antihypertensives drugs, lipid lowering agents, and antiplatelet drugs, laboratory test (6 
to 18 months post intervention) results including fasting blood sugar, glycemic haemoglobin level, 
lipid profile will be collected by investigators via computerized patient record. 
Data analysis 
 
 The Outcome Measurement includes 
1. Blood pressure control rate (Primary outcome) 
2. Change in clinic mean systolic and diastolic BP between baseline and each of the follow 
up point  
3. Accuracy of HBPM by standard checklist in 1-3 months and 9-12 months post-intervention 
4. Practice of HBPM 6-months post-intervention 
5. Change in biochemical markers 

 
 
3-Jan-2016 
6. Change in Body Weight and BMI 
7. Adverse effect  (reported by research subjects) 
Sample size calculation will be based on the mean difference in blood pressure between 
intervention and controls at 9-12 months after baseline. Accounting for the clustering effect by 
practice, the intraclass correlation (ICC) for the intra-cluster correlation in primary care setting 
was taken as 0.01 which was a median estimate reported in previous study (24). In order to have 
80% power and 5% false positive error to detect a difference in blood pressure of 3mmHg with 
assumed standard deviation of 5mmHg, there will be 216 subjects (25) which will be obtained by 
sampling 6 general outpatient clinics randomly, with 36 subjects each clinic in intervention group 
and 36 subjects each clinic in control group. Assuming 20% of attrition rate for 6-12 months 
follow-up, we need to recruit 45 subjects in each group per clinic at baseline, in total of 270 
subjects. 
Descriptive statistics including mean, standard deviation of continuous outcomes and proportion 
of dichotomous outcomes will be calculated. Primary analysis will be an intention-to-treat analysis 
of the difference in outcomes between groups at 6-18 months after baseline. As with repeated 
measurement for patients, generalized estimating equation models using identify link will be 
conducted to assess differences in continuous outcomes within-group and between groups, 
adjusting for baseline patients’ characteristics and clustering of patients per practice. Generalized 
estimating equation models using logistic link will be conducted to analyze differences within-
group and between groups for dichotomous outcomes, adjusting for same sets of patients’ 
characteristics. Missing values will be imputed using last value carrying forward method. 
Repeated analysis will be done for per-protocol analysis. 
All statistical analyses will be performed using SPSS Windows 21.0 program. P-value less than 0.05 
will be considered statistically significant. 
Data collection throughout the trial 
Demographic Questions  
Measurements 
Duration of HT 
BMI (BH/ BW) 
Past Medical history 
Waist circumference 
Contra-indications to antihypertensive drugs 
Clinic BP (sitting position/ standing position) 
Current HT medication 
Lab Test: FBS, Lipid profile, eGFR, Urine PCR 
 
HBPM Technique 
 
 

 
 
3-Jan-2016 
Qualitative Study on Evaluation of the Programme 
Individual interviews (30-45 minutes) to 30 subjects from intervention group will be performed 2-
4 months after education seminar and 1st doctor consultation (whenever later).  Views on the self-
monitoring, home BP reading interpretation blood pressure treatment targets, will be collected. 
Sampling Method:  30 subjects with uncontrolled hypertension, some have attended intervention 
group, with different sex, age group, health literacy and occupations will be interviewed. 
Semi-structured interview guide for patients and their family caregivers using social 
cognitive theory(26) as framework 
Framework 
Interview questions 
Overall experience & 
attitude 
Does high blood pressure (BP) border you?  
Why? 
Tell us about your general impression on Self-blood pressure 
monitoring (SBPM) 
Self-monitoring 
mechanism 
- 
Value of 
Behaviour 
- 
Motivation 
 
Why do think it is important / not important for SBPM? 
Probing 1: (if important) What do you expect from SBPM? How 
and Why? 
Probing 2: (if not important) What are more important than SBPM 
in your disease management? 
Is there any particular person, or reason, asked you to perform 
SBPM regularly? 
- 
consistency 
Do you get your BP checked regularly? 
How to do it?  
Probing: Where? Who? What is / are the machine(s)? 
- 
temporal 
proximity 
- 
self-diagnosis 
Do you notice anything will affect the SBPM readings? 
What was your observation? What do you think was the 
relationship? 
Do you think the BP readings means anything?  
probing 1: such as have, or have no health problem 
probing 2: where did you learn that BP reading means problem/ 
no problem? Tell me more about that 
Self-judgment 
mechanism 
- 
Self-comparison 
You have measured many BP readings at home. How’s the BP 
reading change in different time of the day/ over a period time? 
What do you think was the reasons of your BP variation?  
 
- 
Social 
comparison 
How were your BP readings when compare with your friends or 
family, or other patients?  
How do you feel about that?  
Why do you have that feeling? 
- 
Statistical 
comparison 
Do you know what is the standard BP target readings?  
How did you acquire the BP level? 
Do you think your BP is up to standard? Why? 
- 
Education  
- 
Modelling 
How did you learn SBPM?  Tell me about your experience 

 
 
3-Jan-2016 
Do think your SBPM technique is correct? How did you do it at 
home? 
Probing: (if not correct) Did anyone comment on your SBPM 
technique, can you share the comment with me? 
Did you observe anyone else how to measure BP?   
Probing: How did you feel about learning SBPM? 
Self-evaluation 
mechanism 
- 
Self-satisfaction 
Are you happy with/ worry about your SBPM readings so far? 
What are you goal? (aim or target from SBPM) 
- 
Self-incentives 
If any, what are the benefit of SBPM? 
(Negatively, what are the unwanted or negative effects of SBPM?)  
Why? 
- 
External Reward 
Any tangible benefits of SBPM regularly? Can you describe? 
Overall Comment on 
Education program  
(If attended before) 
What is your comment on the RAMP education program? 
Have you learnt anything new? Do you change (your behaviour) 
after attending the program? 
 

 
 
3-Jan-2016 
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(6) Campbell NR, Berbari AE, Cloutier L, Gelfer M, Kenerson JG, Khalsa TK, et al. Policy statement 
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(13) Campbell NRC, Milkovich L, Burgess E, McKay DW. Self-measurement of blood pressure: 
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(25) Hintze J. PASS 2008. NCSS, LLC. Kaysville, Utah. Sample size and power software. 2008 
(26) Bandura, A. (1986). Social foundations of thought and action: a social cognitive theory. 
Englewood Cliffs, N.J., Prentice-Hall. 
 
 
 
 

 
 
3-Jan-2016 
 
PATIENT INFORMATION  
 
Enhance Antihypertensive Compliance in Response to Home Blood Pressure 
Monitoring in Older People with Uncontrolled Hypertension  
 
 
Conducted by: 
Department of Family Medicine & Primary Health Care, Kowloon West Cluster, Hospital 
Authority 
 
Background 
 
Hypertension is common and it is well known that appropriate treatment can help to prevent 
or delay disease complication. We notice that many older people concern about their blood 
pressure control and therefore performing home blood pressure (blood pressure) 
monitoring.  They want to participant in the discussion of their hypertension drug treatment. 
We are interested to find out whether older people can have better blood pressure control 
by involving patients in the decision of hypertension treatment as well as nurse education 
and follow up. By doing so, we hope to make a strategy for improvement hypertension 
patient health status 
 
 
Study procedure 
 
This is a questionnaire, measurement, doctor consultation, followed by nurse group 
education and individual follow up study last for 6 to 9 months.   
1. The questionnaire will be conducted today by face to face or self-administered with 
the help from our research helper. You will be asked a set of questions about your 
symptoms and performing measurement on your body weight and waist 
circumference. The questionnaires and measurement will be repeated 6 months 
later 
2. Doctors will review all of your health status and prescribe most appropriate 
treatment as usual.   
3. You may or may not be invited to attend 2 group education seminars lead by clinic 
nurse and doctors each will last for 2 hours, a Blood Pressure Device will be loaned 
to you, followed by nurse individual follow up 
4. 2 Laboratory blood and urine test will be performed within 4 weeks and 6 months 
later.  We will check your blood sugar, cholesterol level, urate level, kidney 
functions as well as urine protein concentration.  The test results will be explained 
to you during nurse individual follow up. 
5. You are expected attend as scheduled.  All of your home record should be shown to 
your doctors and nurses every time you come back to clinic 
 
We will retrieve your data including sex, age, educational level, disease information and 
recent investigation results from the hospital computer system for data analysis. There will 
be no sensitive date (neither your name nor ID number) appear in the research record. 

 
 
3-Jan-2016 
 
Risk 
There may be mild discomfort during blood taking. 
  
Benefits 
 
You will not have any direct benefit by participating in this study. However, we will gain 
an understanding condition of hypertension because of the data obtained by your 
involvement in the study. This information may help further strategic planning of health 
services thereby helping future patients. 
 
Upon completion of the study, a supermarket coupon valued of fifty Hong Kong dollars as 
a token of appreciation for your time and contribution 
If any extra visit (e.g. education talk, nurse follow up) is required, a supermarket coupon 
of fifty dollars Hong Kong dollars will be reimbursed. 
 
Confidentiality 
 
Your participation in the study will be treated as confidential and any records or results 
relating to the study will not be disclosed to any third party other than investigators. 
Research ethics committee or regulatory authority(ies) will be granted direct access to the 
subject’s original medical records for verification of clinical trial procedures and/or data, 
without violating the confidentiality of the subject, to the extent permitted by the applicable 
law and regulations.  
 
Only your unique patient number will appear in the study document. Information obtained 
in the study may be used in publications or reports but you will not be identified or referred 
to by name. 
 
 
Consent 
 
The decision to join this study is entirely voluntary. You can refuse to participate or 
withdraw from the study at any time without providing reasons and your standard of 
care will not be affected. You will be timely updated of new information that may be 
relevant to your willingness to continue participation in study. If you withdraw from 
the study, your information will be destroyed and the data will not be used in the study. 
 
Questions 
 
If you have any questions related to this study at any time please contact Ms Margaret Lam 
in Ha Kwai Chung GOPC, Tel: 7321 7578. 
 
 

 
 
3-Jan-2016 
PATIENT INFORMED CONSENT 
 
Protocol Number:  
 
Enhance Antihypertensive Compliance in Response to Home Blood Pressure 
Monitoring in Older People with uncontrolled Hypertension  
 
Conducted by: 
Department of Family Medicine & Primary Health Care, Kowloon West Cluster, Hospital 
Authority 
Subject Number  
 
 
 
 
 
 
I                           (Name of patient)                 (HKID number) have obtained adequate 
information of the above study and understand its nature, purpose, possible benefits and 
potential risks. I understand I will receive a copy of my signed consent form. I also 
understand that my doctor and the sponsor organization can stop my participation in this 
study without my consent. I have no obligation to participate and can withdraw at any time 
without any reason and my medical care will not be affected in future. I have also been 
given enough time to decide whether to participate or not. 
 
As a participant in the study, I understand that my record will be accessible to authorized 
persons but the records will be kept confidential. 
 
I hereby confirm my agreement to the above and to participate voluntarily in this study. 
 
 
                                                                          
Signature of Participant                            Date  
 
 
                                                                          
Name and Signature of Witness                      Date  
 
Physician/Investigator Statement: I have carefully explained to the participant the nature 
of the study. I hereby certify that to the best of my knowledge the participant signing this 
consent form understands clearly the nature, demands, risks and benefits involved in 
participating in this study. A medical problem or language or educational barrier has not 
prevented a clear understanding of the participant’s involvement in this study. 
 
 
                                                                       
Name and Signature of Research staff                 Date