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

September 5, 2021 updated by: Dr. Sau-nga Fu, The University of Hong Kong

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult
  2. Chinese
  3. on hypertensive treatment
  4. 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.
  5. willing and capable to perform home BP monitoring by themselves on daily basis. -

Exclusion Criteria:

  1. unable to perform the home monitoring either by themselves
  2. mentally incapacitated
  3. arrhythmias
  4. unstable angina
  5. serum creatinine > 250 mmol/l
  6. orthostatic hypotension
  7. severe left ventricular impairment
  8. severe aortic stenosis
  9. pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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
Other Names:
  • HBPM
No Intervention: Control Group
Usual Care of hypertension in primary care clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinic Blood Pressure control rate
Time Frame: 18 months
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
Time Frame: 18 months
To compare the BW and BMI over time
18 months
Change of fasting blood sugar level
Time Frame: 18 months
To compare the fasting blood sugar level over time
18 months
Change of low density lipoprotein level (LDL)
Time Frame: 18 months
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
Time Frame: 6 months, 12 months and 18 months
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
Time Frame: 6 months, 12 months and 18 months
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
Time Frame: 5 patients are interviewed before intervention, 6 weeks post-intervention, different time frame after patients' hypertension diagnosed
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Sau Nga FU, MBBS, Kwoloon West Cluster, Hospital Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 5, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KW/EX-15-115(88-14)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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