HypertensionNCT02551393
Enhancing the Risk Assessment and Management Program by Promotion of Self-blood Pressure Monitoring
A study testing Home Blood Presssure Monitoring, Education in people with Hypertension, run by The University of Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Home Blood Presssure Monitoring, Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- unable to perform the home monitoring either by themselves
- mentally incapacitated
- arrhythmias
- unstable angina
- serum creatinine > 250 mmol/l
- orthostatic hypotension
Show all 9Show fewer
- severe left ventricular impairment
- severe aortic stenosis
- pregnancy.
About this study
Official title: 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
Read the 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
- Conditions
- Hypertension
- Being tested
- Home Blood Presssure Monitoring, Education
- Keywords
- Home Blood Pressure Monitoring, Health literacy, Blood Pressure control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Blood Presssure Monitoring, EducationBehavioural
Also called HBPM
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Home Blood Presssure Monitoring, Education |
| Control Group | No intervention | Usual Care of hypertension in primary care clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (6)
Proportion of subjects with normal body mass index
To compare the BW and BMI over time
Measured: 18 months
Change of fasting blood sugar level
To compare the fasting blood sugar level over time
Measured: 18 months
Change of low density lipoprotein level (LDL)
To compare the low density lipoprotein level (LDL) over time
Measured: 18 months
Change in mean clinic Systolic blood pressure (SBP) intervention group when compare with control group
To comparer the SBP level over time
Measured: 6 months, 12 months and 18 months
Change in mean clinic diastolic blood pressure DBP intervention group when compare with control group
To compare intervention group when compared with control group
Measured: 6 months, 12 months and 18 months
Qualitative study of patients' view and experience of home blood pressure monitoring
Patients' experience were report in the framework of the social cognitive theory
Measured: 5 patients are interviewed before intervention, 6 weeks post-intervention, different time frame after patients' hypertension diagnosed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start1 Apr 2016
- Primary completion30 Mar 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Dr. Sau-nga Fu, The University of Hong Kong
- Investigators
- Sau Nga FU, MBBS, Principal investigator, Kwoloon West Cluster, Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551393
- Sponsor's protocol ID
- KW/EX-15-115(88-14)
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2015
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34039693Fu 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.
PubMed 32810355
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Study on the Risk Assessment and Management Program for Home Blood Pressure Monitoring in Population With Inadequate Health Literacy
- ClinicalTrials.gov ID
- NCT02551393
- Acronym / sponsor ID
- KW/EX-15-115(88-14)
- Conditions
- Hypertension
- Keywords
- Home Blood Pressure Monitoring, Health literacy, Blood Pressure control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Home Blood Presssure Monitoring, EducationDoctors 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 |
| Control Group | No intervention | –Usual Care of hypertension in primary care clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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. -
Key exclusion criteria (9 listed)
- unable to perform the home monitoring either by themselves
- mentally incapacitated
- arrhythmias
- unstable angina
- serum creatinine > 250 mmol/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Blood Presssure Monitoring, EducationAlso: HBPMDoctors 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 | Behavioural | Intervention Group |
Primary outcome
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.
6 secondary outcomes
Proportion of subjects with normal body mass index
Time frame: 18 months
Change of fasting blood sugar level
Time frame: 18 months
Change of low density lipoprotein level (LDL)
Time frame: 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
Change in mean clinic diastolic blood pressure DBP intervention group when compare with control group
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 34039693Fu 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.
- Derived from this study: PubMed 32810355Fu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sau Nga FU, MBBS principal investigator
Kwoloon West Cluster, Hospital Authority
Questions about this trial
What is this clinical trial studying?
A study testing Home Blood Presssure Monitoring, Education in people with Hypertension, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinic Blood Pressure control rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551393, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.