임상연구정보서비스

Search: Search

Financial InceNtives for cArdiac rehabilitioN ComplEtion (FINANCE) (Single blind Pragmatic RCT)

Status Approved

First Submitted Date

2021/03/29
Registered Date

2021/04/07
Last Updated Date

2022/12/16

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006063
Unique Protocol ID	CNUH-2021-100
Public/Brief Title	Financial InceNtives for cArdiac rehabilitioN ComplEtion (FINANCE) (Single blind Pragmatic RCT)
Scientific Title	Financial InceNtives for cArdiac rehabilitioN ComplEtion (FINANCE) (Single blind Pragmatic RCT)
Acronym	FINANCE
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CNUH-2021-100
Approval Date	2021-03-29
Institutional Review Board Name	Chonnam national university hospital institutional review board
Institutional Review Board Address	3dong 5 floor IRB administration office, Chonnam national university hospital, 42, Jebong-ro, Dong-gu, Gwangju
Institutional Review Board Telephone	062-220-5257
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jae -Young Han
Title	M.D.,Ph.D
Telephone	+82-62-220-5198
Affiliation	Chonnam National University Hospital
Address	Department of Physical medicine and Rehabilitation, 42, Jebong-ro, Dong-gu, Gwangju
Contact Person for Public Queries
Name	Hae Young Yu
Title	B.S
Telephone	+82-62-1566-5186
Affiliation	Chonnam National University Hospital
Address	Department of Physical medicine and Rehabilitation, 42, Jebong-ro, Dong-gu, Gwangju
Contact Person for Updating Information
Name	Min A Jeong
Title	B.S
Telephone	+82-62-220-5198
Affiliation	Chungnam National University Hospital
Address	Department of Physical medicine and Rehabilitation, 282 Munhwa-ro, Jung-gu Daejeon

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-04-27 Actual
Target Number of Participant	48
Primary Completion Date	2023-06-30 , Anticipated
Study Completion Date	2023-06-30 , Anticipated
Name of Study	Chungnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-04-27 ,
Recruitment Status by Participating Study Site 2
Name of Study	Chonnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-07-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Institute of Health
Organization Type	Government
Project ID	2020ER630500

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chonnam National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	(1) Research purpose This study intends to confirm the effect of enhancing the participation and completion rates in patients who are referred for cardiac rehabilitation by comparing those in the group that receives incentives and those in the group that does not receive incentives for cardiac rehabilitation. (2) Clinical research plan A total of 48 participants are required for this clinical research. Participants who voluntarily sign the participation consent form will be reviewed by the inclusion and exclusion criteria according to the clinical research plan. Once the participants are reviewed as suitable for this trial, they will be randomly assigned to the 'incentive group' or the 'control group' with 24 participants in each group. Exercise rehabilitation program will be conducted on both the groups three times a week for three months, for a total of 36 sessions. Evaluation will be conducted through baseline and chart review, after the end of the exercise rehabilitation program (3 months) and at 6 months and 12 months respectively.

Study Summary Information

Lay Summary

(1) Research purpose
This study intends to confirm the effect of enhancing the participation and completion rates in patients who are referred for cardiac rehabilitation by comparing those in the group that receives incentives and those in the group that does not receive incentives for cardiac rehabilitation.

(2) Clinical research plan
A total of 48 participants are required for this clinical research. Participants who voluntarily sign the participation consent form will be reviewed by the inclusion and exclusion criteria according to the clinical research plan. Once the participants are reviewed as suitable for this trial, they will be randomly assigned to the 'incentive group' or the 'control group' with 24 participants in each group. Exercise rehabilitation program will be conducted on both the groups three times a week for three months, for a total of 36 sessions. Evaluation will be conducted through baseline and chart review, after the end of the exercise rehabilitation program (3 months) and at 6 months and 12 months respectively.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Health Services Research
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	Behavioral
Intervention Description	The same 36 sessions of exercise rehabilitation program will be provided to both groups. Incentive provided to the group: - Incentives: 5,000 won each for the first 12 visits (1-12th session) (total 60,000 won), 10,000 won each for the next 12 visits (13th-24th session) (total 120,000 won), 15,000 won each for the last 12 visits (25th-36th session) (total 180,000 won), and transportation expenses of 360,000 won will be paid if the participant attends all 36 sessions. The control group will not receive any payment.
Number of Arms	2
Arm 1	Arm Label Incentive group
	Target Number of Participant 24
	Arm Type Experimental
	Arm Description : Incentive will be provided for participation in all 36 outpatient exercise programs. - Incentives: 5,000 won each for the first 12 visits (1-12th session) (total 60,000 won), 10,000 won each for the next 12 visits (13th-24th session) (total 120,000 won), 15,000 won each for the last 12 visits (25th-36th session) (total 180,000 won), and transportation expenses of 360,000 won will be paid if the participant attends all 36 sessions.
Arm 2	Arm Label control group
	Target Number of Participant 24
	Arm Type No intervention
	Arm Description Control and incentive groups both will participate in the same 36 outpatient exercise programs.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I25.9)Chronic ischaemic heart disease, unspecified Cardiovascular disease
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~84Year
	Description : Male and female patients aged ≥19 years or above and <85 years : Patients who have been hospitalized for cardiovascular disease and are referred for multidisciplinary cardiac rehabilitation consultation after acute treatment : Patients who consent to participate in cardiac rehabilitation and as participants of the research
Exclusion Criteria	: Patients who are contraindicated for cardiopulmonary test and exercise training or patients who have difficulties in participating in this study due to other medical reasons or are excluded as per the researcher’s discretion (Contraindications: unstable angina symptoms, acute myocardial infarction (within 2 days), uncontrolled ventricular arrhythmia, third-degree atrioventricular block without artificial pacemaker, acute congestive heart failure, severe aortic stenosis, acute systemic disease, thrombophlebitis, thrombosis, active or suspected myocarditis, pericarditis) : Patients who are judged to be at risk of developing serious health problems from the exercise training
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Cardiac rehabilitation participation rate (number of participations out of the 36 exercise programs)
Timepoint	3 months, at the end of the exercise program
Primary Outcome(s) 2
Outcome	Cardiac rehabilitation completion rate (participation of patients in 18 or more out of 36 exercise programs)
Timepoint	3 months, at the end of the exercise program
Primary Outcome(s) 3
Outcome	PROM (Patient-Reported Outcome Measures) (KASI, EQ-5D, PHQ-9, CCI, physical activity)
Timepoint	- Baseline, 3 months, 6 months, 12 months
Secondary Outcome(s) 1
Outcome	Cardiopulmonary function index (VO2 max, VO2 at AT, MET, etc.)
Timepoint	- Baseline, 3 months, 6 months, 12 months

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top