Financial incentives for hypertension control in China (FIHCC study)

ISRCTN ISRCTN13467677
DOI https://doi.org/10.1186/ISRCTN13467677
Submission date
23/04/2019
Registration date
16/05/2019
Last edited
10/06/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Liqiang Zheng
Scientific

36 SanHao Street
Heping District
Shenyang
110004
China

ORCiD logoORCID ID 0000-0003-0101-9398
Phone 86-24-96615
Email llwyh@sj-hospital.org
Miss Yundi Jiao
Public

39, Huaxiang Road
Tiexi District
Shenyang
110022
China

Phone 86-18940252778
Email jiaoyundi1987@163.com

Study information

Study designMulti-center open randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleFinancial incentives for hypertension control among community-based hypertensive populations: a multi-center, randomized controlled trial
Study acronymFIHCC
Study objectivesCompared to control group, the financial incentives will lower systolic and diastolic BP among hypertensive patients over an 12-month period.
Ethics approval(s)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
Health condition(s) or problem(s) studiedHypertension
InterventionWe 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 typeBehavioural
Primary outcome measureSystolic blood pressure at the baseline and after 1, 3, 6, and 12 months
Secondary outcome measures1. 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) at 1, 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 study start date01/01/2019
Completion date01/07/2021

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit35 Years
Upper age limit75 Years
SexBoth
Target number of participants400
Total final enrolment207
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/08/2019
Date of final enrolment27/03/2021

Locations

Countries of recruitment

  • China

Study participating centres

Shengjing Hospital of China Medical University
110004
China
Fushun Mining General Hospital of Liaoning Health Industry Group
113008
China
Dandong Central Hospital
118000
China
Anshan Central Hospital
114001
China
Fuxin Mining General Hospital of Liaoning Health Industry Group
123099
China
Fenyang Hospital of Shanxi Medical University
032200
China

Sponsor information

Shengjing Hospital of China Medical University
Hospital/treatment centre

36 SanHao Street
Heping District
Shenyang
110004
China

Phone 86-24-96615
Email llwyh@sj-hospital.org
ROR logo "ROR" https://ror.org/0202bj006

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 18/07/2022 22/07/2022 Yes No
Protocol article 03/02/2020 10/06/2024 Yes No

Editorial Notes

10/06/2024: Publication reference added.
22/07/2022: Publication reference added.
10/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/07/2020 to 27/03/2021.
2. The final enrolment number has been added.
15/05/2019: Trial’s existence confirmed by Shengjing Hospital of China Medical University Medical Ethics Committee