Plain English Summary
Background and study aims
Hypertension, a major risk factor for cardiovascular disease (CVD) and premature death, has been a leading public health problem worldwide. How to make hypertensive patients positively change unhealthy lifestyles and promote their regular medication is an important problem that needs to be addressed in current hypertension control. Financial incentives have been explored in smoking, weight loss, and diabetes and confirmed that it can significantly increase the rates of smoking cessation, promote obese participants lost significantly more weight, and improve self-monitoring rates of blood pressure (BP), blood glucose and weight in diabetic patients. Therefore, the aim of this study is to explore whether financial incentives will improve hypertension control among community-based uncontrolled hypertensive patients in China.
Who can participate?
Adults aged 35 - 75 years who have uncontrolled hypertension
What does the study involve?
Interested subjects should complete a screening questionnaire on the web first, and then the researchers will contact the potential subjects and confirm them at the recruitment location. Subjects who meet the inclusion criteria will be required to sign an informed consent. Participants will be randomized to the intervention and control group. The control group will be provided with patient education and can communicate with the researcher through the mobile at any time. The participants of the intervention group will be provided with patient education but also receive financial incentives. Financial incentives include the rewards for self-measurement of BP and the participants whom BP values were decreased by 10 mmHg relative to baseline or achieve hypertension control (BP < 140/90 mmHg). The intervention lasts one year in total and the study lasts three years in total. The researchers will collect data at baseline, months 1, 3, 6, and 12. Data collection locations are carried out at hospitals in the regional centers. The data was obtained by standardized questionnaires and measurement.
What are the possible benefits and risks of participating?
The results of this study will help improve the control rate of hypertension and lower blood pressure levels in urban communities. Because of lowering blood pressure, you may further reduce the chance of stroke recurrence, coronary heart disease and heart failure. All participants will be asked to complete questionnaires, which may be psychologically uncomfortable.
Where is the study run from?
The FHICC study is being run by Shengjing Hospital of China Medical University, Fushun Mining General Hospital of Liaoning Health Industry Group, Dandong Central Hospital, Anshan Central Hospital, Fuxin Mining General Hospital of Liaoning Health Industry Group and Fenyang Hospital of Shanxi Medical University and Shengjing Hospital of China is the lead center.
When is the study starting and how long is it expected to run for?
January 2019 to July 2021
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
1. Dr.Liqiang Zheng
liqiangzheng@126.com
2. Miss.Yundi Jiao
jiaoyundi1987@163.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Liqiang Zheng
ORCID ID
http://orcid.org/0000-0003-0101-9398
Contact details
36 SanHao Street
Heping District
Shenyang
110004
China
86-24-96615
llwyh@sj-hospital.org
Type
Public
Additional contact
Miss Yundi Jiao
ORCID ID
Contact details
39
Huaxiang Road
Tiexi District
Shenyang
110022
China
86-18940252778
jiaoyundi1987@163.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Financial incentives for hypertension control among community-based hypertensive populations: a multi-center, randomized controlled trial
Acronym
FIHCC
Study hypothesis
Compared to control group, the financial incentives will lower systolic and diastolic BP among hypertensive patients over an 12-month period.
Ethics approval
Approved 26/03/2019, Shengjing Hospital of China Medical University Medical Ethics Committee (Shengjing Hospital of China Medical University, 36 SanHao Street, Heping District, Shenyang, 110004, China; 86-24-96615-10027; wangh3@sj-hospital.org), ref:2019PS397K
Study design
A multi-center open randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hypertension
Intervention
We will recruit 400 eligible subjects and assign the subjects 1:1 to the intervention and control groups by block randomization, with 200 in each group.
Participants in control group will receive interactive management of mobile devices, including:
1. Patient education: researchers will send relevant knowledge of hypertension prevention and treatment at the beginning of each month in the WeChat group, including the definition and severity of hypertension, methods of correctly measuring BP, lifestyle prevention, the types and selection of antihypertensive drugs, the harms of hypertension complications.
2. Communication: If the patients have any questions during the intervention and follow-up, they can communicate with the researcher through the mobile at any time, and the researcher will answer their questions.
The participants of the intervention group will implement financial incentives on the basis of control group, and the specific measures include two parts:
1. Participants were encouraged to self-measure BP once a week and record the condition of antihypertensive medications, and the rewards of 5 yuan (red envelope) were received as they record the results accurately and completely every week.
2. At the follow-up months 1, 3, 6, and 12, researchers measured participants′ BP and gave a reward of 50 yuan or equivalent gift (shopping cards, phone bills, cooking oil, etc.) to the patients whom BP values were decreased by 10 mmHg (compared to baseline BP values) or achieve the control criteria (SBP/DBP <140/90 mmHg).
The study will last one year in total and researchers will collect data at baseline, months 1, 3, 6, and 12.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Systolic blood pressure at the baseline and after 1, 3, 6, and 12 months.
Secondary outcome measures
1. Diatolic blood pressure measured using blood pressure monitors at the baseline, and after 1,3,6 and 12 months.
2.The proportion of hypertension control (BP <140/90 mmHg) at1, 3, 6, and 12 months.
3.Medication adherence at the baseline, and after 1, 3, 6, and 12 months.
4.Body mass index assessed by dividing weight in kg by height in metres at the baseline, and after 1, 3, 6, and 12 months.
5.Physical activity at the baseline, and after 1, 3, 6, and 12 months.
6.Counseling frequency at the baseline, and after 1, 3, 6, and 12 months.
7.Counseling content at the baseline, and after 1, 3, 6, and 12 months.
8.Number of steps in WeChat at the baseline, and after 1, 3, 6, and 12 months.
9.Pulmonary function at the baseline and after 12 months.
10.Pulse wave velocity at the baseline and after 12 months.
11.Ankle brachial index at the baseline and after 12 months.
12.Cost-effectiveness
Overall trial start date
01/01/2019
Overall trial end date
01/07/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 35 - 75 years
2. Uncontrolled hypertensive patients (SBP/DBP ≥ 140/90mmHg)
3. Have WeChat and use skillfully
4. Local residents, who live in local places for more than 12 months
5. Voluntarily joined and signed informed consents
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Pregnant women or women who are planning to become pregnant in the next year
2. Plans to move from the neighborhood in the next year
3. Malignant tumors or severe liver, kidney dysfunction
4. Can not be proficient in using WeChat
5. Secondary hypertension patients
6. Disagree to participate in the study or cannot give the informed consent
Recruitment start date
01/08/2019
Recruitment end date
01/07/2020
Locations
Countries of recruitment
China
Trial participating centre
Shengjing Hospital of China Medical University
110004
China
Trial participating centre
Fushun Mining General Hospital of Liaoning Health Industry Group
113008
China
Trial participating centre
Dandong Central Hospital
118000
China
Trial participating centre
Anshan Central Hospital
114001
China
Trial participating centre
Fuxin Mining General Hospital of Liaoning Health Industry Group
123099
China
Trial participating centre
Fenyang Hospital of Shanxi Medical University
032200
China
Sponsor information
Organisation
Shengjing Hospital of China Medical University
Sponsor details
36 SanHao Street
Heping District
Shenyang
110004
China
86-24-96615
llwyh@sj-hospital.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
31/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list