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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02551393
Enrollment
291
Registered
2015-09-16
Start date
2016-04-01
Completion date
2018-12-30
Last updated
2021-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Home Blood Pressure Monitoring, Health literacy, Blood Pressure control

Brief 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

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

Interventions

BEHAVIORALHome 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

Sponsors

Hospital Authority, Hong Kong
CollaboratorOTHER_GOV
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Clinic Blood Pressure control rate18 monthsAfter 18 months of treatment, to compare BP control rate in the intervention group and the control group.

Secondary

MeasureTime frameDescription
Change of fasting blood sugar level18 monthsTo compare the fasting blood sugar level over time
Change of low density lipoprotein level (LDL)18 monthsTo compare the low density lipoprotein level (LDL) over time
Proportion of subjects with normal body mass index18 monthsTo compare the BW and BMI over time
Change in mean clinic diastolic blood pressure DBP intervention group when compare with control group6 months, 12 months and 18 monthsTo compare intervention group when compared with control group
Qualitative study of patients' view and experience of home blood pressure monitoring5 patients are interviewed before intervention, 6 weeks post-intervention, different time frame after patients' hypertension diagnosedPatients' experience were report in the framework of the social cognitive theory
Change in mean clinic Systolic blood pressure (SBP) intervention group when compare with control group6 months, 12 months and 18 monthsTo comparer the SBP level over time

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026