Condition category
Circulatory System
Date applied
23/04/2019
Date assigned
16/05/2019
Last edited
15/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

15/05/2019: Trial’s existence confirmed by Shengjing Hospital of China Medical University Medical Ethics Committee