Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02551393 |
| Other study ID # |
KW/EX-15-115(88-14) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2016 |
| Est. completion date |
December 30, 2018 |
Study information
| Verified date |
September 2021 |
| Source |
The University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
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 ageā„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
