Back to resultsDischarge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Discharge Education of Chinese Medicine
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Patient Education, Chinese Medicine
Eligibility Criteria
Inclusion Criteria:
- Candidates for this study were admitted to the hospital with a diagnosis of heart failure and documented left ventricular systolic dysfunction (ejection fraction<0.40).
Exclusion Criteria:
- CKD4 and CKD5
Sites / Locations
- Guangdong Provincial Hospital of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
patient education and Chinese medicine
patient education
Arm Description
1-hour, one-on-one teaching session with a educator to the standard discharge education of Integrated Traditional and Western Medicine
no discharge education
Outcomes
Primary Outcome Measures
total number of days hospitalized
total number of days hospitalized in the 84-day follow-up period.
Secondary Outcome Measures
Full Information
NCT ID
NCT03447392
First Posted
February 16, 2018
Last Updated
February 26, 2018
Sponsor
Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03447392
Brief Title
Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure
Official Title
Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
January 8, 2018 (Actual)
Study Completion Date
January 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education alone is not known. The investigators hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure.
Detailed Description
Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education of Integrated Traditional and Western Medicine is not known. The investigators hypothesized that a patient discharge education of Integrated Traditional and Western Medicine program would improve clinical outcomes in patients with chronic heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Patient Education, Chinese Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient education and Chinese medicine
Arm Type
Experimental
Arm Description
1-hour, one-on-one teaching session with a educator to the standard discharge education of Integrated Traditional and Western Medicine
Arm Title
patient education
Arm Type
No Intervention
Arm Description
no discharge education
Intervention Type
Behavioral
Intervention Name(s)
Discharge Education of Chinese Medicine
Intervention Description
Discharge Education of Integrated Traditional and Western Medicine
Primary Outcome Measure Information:
Title
total number of days hospitalized
Description
total number of days hospitalized in the 84-day follow-up period.
Time Frame
84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Candidates for this study were admitted to the hospital with a diagnosis of heart failure and documented left ventricular systolic dysfunction (ejection fraction<0.40).
Exclusion Criteria:
CKD4 and CKD5
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu ZOU
Organizational Affiliation
The Second Clinical College, Guangzhou University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
12. IPD Sharing Statement
Learn more about this trial
Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure
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