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

NCT02551393 | Completed DMC

• 1 other identifier: KW/EX-15-115(88-14)
• Study Type: interventional
• Target: 291
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Keywords

Home Blood Pressure Monitoring; Health literacy; Blood Pressure control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of subjects with normal body mass index

  18 months

• Change of fasting blood sugar level

  18 months

• Change of low density lipoprotein level (LDL)

  18 months

• Change in mean clinic Systolic blood pressure (SBP) intervention group when compare with control group

  6 months, 12 months and 18 months

• Change in mean clinic diastolic blood pressure DBP intervention group when compare with control group

  6 months, 12 months and 18 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Usual Care of hypertension in primary care clinic

Interventions

Home Blood Presssure Monitoring, Education BEHAVIORAL

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

Also known as: HBPM

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Related Publications (2)

• Fu SN, Dao MC, Wong CKH, Cheung BMY. Knowledge and practice of home blood pressure monitoring 6 months after the risk and assessment management programme: does health literacy matter? Postgrad Med J. 2022 Aug;98(1162):610-616. doi: 10.1136/postgradmedj-2020-139329. Epub 2021 May 26.

  PMID: 34039693 DERIVED

• Fu SN, Dao MC, Luk W, Lam MCH, Ho ISF, Cheung SK, Wong CKH, Cheung BMY. A cluster-randomized study on the Risk Assessment and Management Program for home blood pressure monitoring in an older population with inadequate health literacy. J Clin Hypertens (Greenwich). 2020 Sep;22(9):1565-1576. doi: 10.1111/jch.13987. Epub 2020 Aug 18.

  PMID: 32810355 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Educational Status; 4-(2-(4-hydroxybenzyl)-phenoxy)-N-methylbutylamine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Sau Nga FU, MBBS

  Kwoloon West Cluster, Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D Student

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 16, 2015
• Study Start: April 1, 2016
• Primary Completion: March 30, 2018
• Study Completion: December 30, 2018
• Last Updated: September 10, 2021

Record last verified: 2021-09