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Effects of Nurse-led Case Management Based on Prevention and Control of Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nurse -led case management
Routine inpatient care and post-discharge follow-up management
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, case management

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • In line with the diagnosis of Chinese 2019 Guidelines for AMI. Age greater than or equal to 18 years old and less than or equal to 75 years old Patients have clear consciousness and agree to participate in this study.

Exclusion Criteria:

  • Verbal communication disorders. Patients have a clear history of allergic constitution, and have allergies or intolerance to the drugs recommended by the guidelines (including antiplatelet drugs, ẞ receptor blockers, statins, various antihypertensive and hypoglycemic drugs, etc.).

Patients have severe heart, brain, liver, kidney, motor dysfunction.

Sites / Locations

  • Jingwen Hu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

Patients in the experimental group will receive full-course case management from a multidisciplinary team from admission to 6 months after discharge

Patients in the control group will receive routine inpatient care and post-discharge follow-up management

Outcomes

Primary Outcome Measures

The 36-item Short Form Health Survey for HRQoL
Health-related quality of life
Coronary artery disease self-management scale for self-management behaviors
Self-management behaviors
the numbers of unplanned readmission
Unplanned readmission
the number of deaths from cardiac causes
Deaths from cardiac causes

Secondary Outcome Measures

the numbers of no smoking
Smoking
systolic and diastolic blood pressure (mmHg)
Blood Pressure.
Glycated hemoglobin A1c (%)
Collect fasting venous blood to measure glycosylated hemoglobin A1c
Body mass index (BMI),kg/m2
Measure weight and height,then weight and height will be combined to report BMI in kg/m^2
Low-density lipoprotein (mmol/L)
Collect fasting venous blood to measure low-density lipoprotein
Exercise time every week (min)
Inquire the exercise time per week

Full Information

First Posted
April 26, 2022
Last Updated
May 17, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05384028
Brief Title
Effects of Nurse-led Case Management Based on Prevention and Control of Acute Myocardial Infarction
Official Title
Effects of Nurse-led Case Management Based on Multidisciplinary Collaboration in the Whole Course Prevention and Control of Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2022 (Anticipated)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

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
Acute Myocardial Infarction (AMI) is a major disease that endangers people's health China. At present, clinical emphasis is given to "treatment" rather than "prevention", and a large number of AMI patients are hospitalized repeatedly without systematic and standardized health management after acute stage, falling into a vicious circle of "treatment without recovery". Nurse-led case management based on multidisciplinary collaboration is a new mode of disease management. In 1994, the United States took the lead in applying case management to the acute and chronic care system, providing comprehensive care services and promoting comprehensive recovery through multidisciplinary collaboration led by case managers. At present, the case management model of cardiovascular disease in Europe and the United States has been mature, but it is still in the exploratory stage in China. Through the establishment and application of nurse-led AMI case management program based on multidisciplinary collaboration, this study wants to establish a novel, standardized, and easy to popularize AMI whole-course prevention and control mode, providing theoretical and research basis for AMI disease management.
Detailed Description
There are few domestic studies on cardiovascular disease case management in China, and the studies mainly aimed at the application of case management in out-of-hospital follow-up management. At present, there has been no reports on nurse-led the multidisciplinary whole course case management of AMI patients from admission to discharge, diagnosis and treatment, rehabilitation and secondary prevention. This study would apply case management to the whole course management of AMI patients from admission to 6 months after discharge. Pharmacists, nutritionists, rehabilitation specialists and psychiatrists coordinated by nurse would take the initiative to conduct individualized assessment and health guidance, and case managers would participate in the whole process of inpatient diagnosis and treatment. Coordinating multidisciplinary medical resources to jointly implement diagnosis and treatment and rehabilitation for patients can save medical costs and improve the quality of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute Myocardial Infarction, case management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients in the experimental group will receive full-course case management from a multidisciplinary team from admission to 6 months after discharge
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control group will receive routine inpatient care and post-discharge follow-up management
Intervention Type
Other
Intervention Name(s)
Nurse -led case management
Intervention Description
This study would apply case management to the whole course management of AMI patients from admission to 6 months after discharge. Pharmacists, nutritionists, rehabilitation specialists and psychiatrists led by nurse would take the initiative to conduct individualized assessment and health guidance, and case managers would participate in the whole process of inpatient diagnosis and treatment. Coordinating multidisciplinary medical resources to jointly implement diagnosis and treatment and rehabilitation for patients can improve the quality of care.
Intervention Type
Other
Intervention Name(s)
Routine inpatient care and post-discharge follow-up management
Intervention Description
Patients in the control group will receive routine inpatient care and post-discharge follow-up management
Primary Outcome Measure Information:
Title
The 36-item Short Form Health Survey for HRQoL
Description
Health-related quality of life
Time Frame
from baseline to 6 months after discharge
Title
Coronary artery disease self-management scale for self-management behaviors
Description
Self-management behaviors
Time Frame
from baseline to 6 months after discharge
Title
the numbers of unplanned readmission
Description
Unplanned readmission
Time Frame
Through study completion, within 6 months post discharge
Title
the number of deaths from cardiac causes
Description
Deaths from cardiac causes
Time Frame
Through study completion,within 6 months post discharge
Secondary Outcome Measure Information:
Title
the numbers of no smoking
Description
Smoking
Time Frame
from baseline to 6 months after discharge
Title
systolic and diastolic blood pressure (mmHg)
Description
Blood Pressure.
Time Frame
from baseline to 6 months after discharge
Title
Glycated hemoglobin A1c (%)
Description
Collect fasting venous blood to measure glycosylated hemoglobin A1c
Time Frame
from baseline to 6 months after discharge
Title
Body mass index (BMI),kg/m2
Description
Measure weight and height,then weight and height will be combined to report BMI in kg/m^2
Time Frame
from baseline to 6 months after discharge
Title
Low-density lipoprotein (mmol/L)
Description
Collect fasting venous blood to measure low-density lipoprotein
Time Frame
from baseline to 6 months after discharge
Title
Exercise time every week (min)
Description
Inquire the exercise time per week
Time Frame
from baseline to 6 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In line with the diagnosis of Chinese 2019 Guidelines for AMI. Age greater than or equal to 18 years old and less than or equal to 75 years old Patients have clear consciousness and agree to participate in this study. Exclusion Criteria: Verbal communication disorders. Patients have a clear history of allergic constitution, and have allergies or intolerance to the drugs recommended by the guidelines (including antiplatelet drugs, ẞ receptor blockers, statins, various antihypertensive and hypoglycemic drugs, etc.). Patients have severe heart, brain, liver, kidney, motor dysfunction.
Facility Information:
Facility Name
Jingwen Hu
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingwen Hu, Mater
Email
jingwenhu@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effects of Nurse-led Case Management Based on Prevention and Control of Acute Myocardial Infarction

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