Plain English Summary
Background and study aims
High blood pressure (or hypertension) can be caused and influenced by a number of factors including lifestyle and aging. When blood pressure is consistently too high this means that the heart has to work harder to pump blood around your body. Therefore, high blood pressure that is not managed can lead to diseases like a heart attack or stroke. In order to control high blood pressure, behavior modifications and/or treatment using medication may be required. Management may continue as a lifetime endeavor, and often changes to management plans will be needed in response to changing conditions for individual patients. The complexity of causes and long-term dynamics of controlling high blood pressure make personalized management necessary.
Personalized hypertension management (PHMA) is a method which aims to prevent hypertension from harming the health of the patient using eight objective behaviors including:
1. Attending and responding to project messages/contacts
2. Performing self-monitoring and reporting
3. Modifying unhealthy diet habits/practices
4. Maintaining adequate physical exercise/activities
5. Containing tobacco and alcohol consumption
6. Addressing emotion and sleep problems
7. Using clinical checkups and treatment
8. Facilitating family engagement and support.
The aim of this study is to test how effective PHMA is for managing high blood pressure and to identify key facilitators, barriers, and corresponding strategies in disseminating and implementing PHMA.
Who can participate?
Adult patients with a diagnosis of hypertension living in the selected villages in Anhui with participating general practices for over 6 months each year
What does the study involve?
Participants will either receive their usual hypertension care or over the study period. Participants blood pressure and data about their use of healthcare services, health complications, and quality of life using structured questionnaires will be collected at the start of the study and every 12 months for the 5 years following.
What are the possible benefits and risks of participating?
There are not thought to be any risks involved with participating in the study. A possible benefit could be that participants will learn how to better control their hypertension.
Where is the study run from?
60 general practices in Anhui (China)
When is the study starting and how long is it expected to run for?
From February 2020 to July 2025
Who is funding the study?
National Natural Science Foundation of China (China)
Who is the main contact?
Miss Xingrong Shen
xinrongshen@sina.com
Trial website
Contact information
Type
Scientific
Primary contact
Miss Xingrong Shen
ORCID ID
http://orcid.org/0000-0002-9708-9659
Contact details
Anhui Medical University
81 Meishan Road
Hefei
230032
China
+86 0551-65116395
xinrongshen@sina.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Personalized Hypertension Management (PHMA) based on serial assessment and telemedicine in Anhui, China
Acronym
PHMA
Study hypothesis
1. Compared to those in the control condition, hypertension patients in the personalized hypertension management (PHMA) intervention arm will demonstrate: lower systolic and diastolic BP; higher scores on objective behaviors including self-monitoring, medication adherence, healthy diet, physical activities, tobacco/alcohol consumption, anxiety/insomnia coping, and family engagement; and reduced use of medical care due to hypertension and its complications
2. Key facilitators, barriers, and corresponding strategies in disseminating and implementing PHMA will be identified
Ethics approval
Approved 01/03/2020, Anhui Medical University Biomedical Ethics Committee (Anhui Medical University, 81 Meishan Road, Hefei, Anhui, China; +86 0551-65161053; renzhenhua@ahmu.edu.cn), ref: 20200936
Study design
Multi-centre cluster randomized controlled trial using control and synchronous intervention arms
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Hypertension
Intervention
The study adopts a cluster randomized controlled trial (RCT) design involving a total of 60 site communities with 12 in the control arm and 48 in the intervention arm. The control arm maintains existing hypertension patient management; while the intervention arms, personalized hypertension management (PHMA). Project evaluation applies to all arms using the same data collection methods and by the same field data collectors. And detailed intervention in intervention arms varies from patient to patient due to the personalized approach. So, the uneven distribution of site communities between the control and intervention arms were designed to enable detection of potential differences between the control arm and three to four main subgroups with different intervention ingredients in the intervention arm. The analysis and reporting of the trial will be in accordance with the CONSORT guidelines.
The overall goal of PHMA is to prevent hypertension from harming the health of the patient under concern. This goal is reached by eight objective behaviors including:
1. Attending and responding to project messages/contacts
2. Performing self-monitoring and reporting
3. Modifying unhealthy diet habits/practices
4. Maintaining adequate physical exercise/activities
5. Containing tobacco and alcohol consumption
6. Addressing emotion and sleep problems
7. Using clinical checkups and treatment
8. Facilitating family engagement and support.
These objective behaviors are promoted through two intervention stages and four intervention measures. The four intervention measures are: support for self-monitoring (I1), personalized daily message (I2), supervised machine counseling (I3), and signed quarterly feedback (I4). The design of these measures is guided by proven theories or strategies including system synergy, health belief model, social cognition theory, motivational interviewing, nudging strategies, and computerized tailoring. Detailed intervention varies from patient to patient due to the personalized nature of the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Systolic BP/Diastolic BP measured using mercury sphygmomanometer at baseline and every 12 months after baseline for 5 years
Secondary outcome measures
1. Quality of life
2. Occurrence of hypertension-related complications (such as cerebral hemorrhage, coronary heart disease, myocardial infarction, cerebral infarction)
3. Healthcare utilization
4. Scores of objective behaviors
All secondary outcome measures will be measured using structured questionnaires at baseline and every 12 months after baseline for 5 years
Overall trial start date
01/02/2020
Overall trial end date
30/07/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥18 years
2. Living in the selected villages for ≥6 months/year
3. Diagnosed with hypertension
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3,420
Participant exclusion criteria
Previous diagnosis of mental illness, serious illness, or disability
Recruitment start date
01/08/2020
Recruitment end date
30/07/2025
Locations
Countries of recruitment
China
Trial participating centre
Anhui Medical University
81 Meishan Road
Hefei
230032
China
Sponsor information
Organisation
National Natural Science Foundation of China
Sponsor details
83 Shuangqing Road
Haidian District
Beijing
100085
China
+86-10-62327001
bic@nsfc.gov.cn
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, NSFC, NNSF, NNSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
30/07/2026
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list