An integrative program on the population at risk for high blood pressure (hypertension)
| ISRCTN | ISRCTN74154693 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74154693 |
- Submission date
- 27/07/2022
- Registration date
- 02/08/2022
- Last edited
- 19/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The population at risk for hypertension (high blood pressure) has a doubling risk of developing hypertension, and higher illness and death attributable to cardiovascular and cerebrovascular diseases, compared to individuals who are not at risk. Several studies have evaluated the effects of community-based integrative interventions to manage the population at risk for hypertension, including self-monitoring of blood pressure (BP), dietary adjustments, and regular exercises. In China, high-quality evidence is lacking regarding the effects of community-based integrative interventions on the population at risk for hypertension. This study aimed to evaluate the effectiveness of a community-based integrative program in reducing hypertension incidence among the population at high risk for hypertension in Shanghai, Eastern China.
Who can participate?
Adults aged between 18 and 80 years identified as individuals at risk for hypertension with no previous history of hypertension diagnosis or use of anti-hypertensive medication.
What does the study involve?
Participants were randomly divided into two groups (the intervention group and the control group). The intervention group received an integrative program that includes health education, physician follow-up, and self-management. The control group received usual care only. All patients were followed up for one year. Questionnaires were used to investigate risk factors, knowledge, attitudes, and behaviors regarding hypertension prevention for all participants at baseline and follow-up. BP was measured for all participants at baseline and follow-up.
What are the possible benefits and risks of participating?
The researchers did not think that taking part has any major risks. The possible benefits of this study included lower hypertension incidence and improvement in hypertension-related knowledge, attitudes, and behaviors.
Where is the study run from?
Six neighbourhood blocks in Changning District of Shanghai (China)
When is the study starting and how long is it expected to run for?
January 2018 to December 2021
Who is funding the study?
The National Natural Science Foundation of China
Who is the main contact?
Dr Chengyue Li
lichengyue@fudan.edu.cn
Contact information
Principal Investigator
Department of Health Policy and Management
School of Public Health
Fudan University
130 Dong’an Road
Shanghai
200032
China
 ORCID ID |
0000-0001-5829-5129 |
|---|---|
| Phone | +86-21-33561022 |
| lichengyue@fudan.edu.cn |
Study information
| Study design | Cluster-randomized intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | The participant information sheet is not available in web format, please use the contact details to request a participant information sheet: Chengyue Li (lichengyue@fudan.edu.cn). |
| Scientific title | Effectiveness of an integrative program on reducing hypertension incidence among the population at risk for hypertension |
| Study objectives | The integrative program can improve the level of hypertension-related knowledge, attitudes, and behaviors, and can be effective in delaying the development of hypertension in high-risk populations. |
| Ethics approval(s) | Approved 03/03/2017, Fudan University School of Public Health Institutional Review Board (130 Dong’an Road, Shanghai 200032, China; +86 (021) 54237051; no email provided), ref: IRB #2017-TYSQ-03-10. |
| Health condition(s) or problem(s) studied | Population at risk for hypertension |
| Intervention | The researchers conducted a community-based randomized intervention trial among the population at risk for hypertension. They selected community A in Changning District of Shanghai, located in the Eastern Region of China, as the study setting. For the interventions, the randomization process was performed as follows: first, 6 neighbourhood blocks were randomly selected from the 17 neighbourhood blocks in community A for inclusion in the study, by using a computer-generated random number. Three blocks were randomized as the intervention group and the other three were treated as the control group. One lane was randomly selected from each sampled neighbourhood block by using a computer-generated random number to recruit the participants, with approximately 300 to 400 residents in each lane. The study was implemented in October 2019-October 2020. The intervention group was managed through the integrative intervention, and the control group received usual care (i.e., the general practitioners followed up with patients and queried their BP levels, and lifestyles via phone every 6 months). The integrative program consisted of three sections: health education, physician follow-ups, and self-management. The training was provided to all general practitioners (GPs) and staff involved in the intervention group, including the intervention measures for high-risk individuals, the intervention contents, the implementation procedures, and rules for filling out the tables regarding the intervention process. Before the intervention, health education lecture schedules, self-management cards, and health education leaflets were allocated to individuals in the intervention group, and an online group chat using social media (WeChat, Tencent Co. Ltd, China) was also created. All recordings and documents of the management process were employed to ensure that assessment and intervention procedures were standardized across the study sites and all participants. The activities of the interviews, physical assessment procedures, and program implementation were routinely supervised and monitored by senior researchers. |
| Intervention type | Behavioural |
| Primary outcome measure | Incidence of hypertension measured based on BP readings obtained by the automated validated Omron electronic sphygmomanometer among participants in the two groups at baseline and 1-year follow-up. |
| Secondary outcome measures | Changes in hypertension-related knowledge, attitude, behavior (KAB) measured using a structured questionnaire for participants in the two groups at baseline and 1-year follow-up. |
| Overall study start date | 01/01/2018 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 280 for both the intervention and control groups |
| Total final enrolment | 607 |
| Key inclusion criteria | 1. Permanent residents aged 18-80 years of the sampled lane (excluding those who leave this lane for more than half a year) 2. Identified as individuals at risk for hypertension, with a total risk score of more than 20 based on our screening tool 3. Informed consent and willingness to participate in this study 4. No previous history of hypertension diagnosis or use of anti-hypertensive medication 5. With good cognitive function and physical condition |
| Key exclusion criteria | 1. Those with a history of severe mental illness or poor compliance 2. Not identified as individuals at risk for hypertension, with total risk score less than 20 based on our screening tool 3. With a previous history of hypertension diagnosis or use of anti-hypertensive medication |
| Date of first enrolment | 01/10/2019 |
| Date of final enrolment | 30/10/2020 |
Locations
Countries of recruitment
- China
Study participating centre
Changning District
Shanghai
200052
China
Sponsor information
University/education
School of Public Health
130 Dong’an Road, Xuhui District
Shanghai
200032
China
| Phone | +86-021-54237051 |
|---|---|
| gwkyb@fudan.edu.cn | |
| Website | http://www.fudan.edu.cn/en/ |
"ROR" |
https://ror.org/013q1eq08 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets will be available upon request from Chengyue Li (lichengyue@fudan.edu.cn) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 31/07/2022 | 01/08/2022 | No | No | |
| Basic results | 02/09/2022 | 02/09/2022 | No | No | |
| Results article | 17/12/2022 | 19/12/2022 | Yes | No |
Additional files
Editorial Notes
19/12/2022: Publication reference added.
02/09/2022: Basic results summary uploaded.
01/08/2022: Trial's existence confirmed by the Fudan University School of Public Health Institutional Review Board.
