Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-27 @ 10:19 PM
Study NCT ID:
NCT05999695
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-16
First Post:
2023-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-management of Patients With Acute Coronary Syndromes
Sponsor:
Taipei Veterans General Hospital, Taiwan
Organization:
Study Overview
Official Title:
Effects of the Self-management on Anxiety, Depression, Quality of Life and Self-management of Patients With Acute Coronary Syndromes: a Randomized Controlled Trial.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose :
The purpose of this study is to investigate the tracking effect of selfmanagement programs on anxiety, depression, and quality of life in patients with Acute Coronary Syndromes (ACS).
The purpose of this study is to investigate the tracking effect of selfmanagement programs on anxiety, depression, and quality of life in patients with Acute Coronary Syndromes (ACS).
Detailed Description:
Research Design :
This study the first phase is to construct and develop interventional measures for self-management of patients with ACS. According to the associated factors of study, the intervention measures are designed based on self-management. A pilot study will be conducted to improve research and to develop better selfmanagement interventions in the future. At the secondary stage: a randomized controlled trial with a random sampling design is used to investigate the effects of self-management programs on anxiety, depression, and quality of life in patients with ACS. The study will conduct in a cardiac medicine ward or coronary intensive care center of a north medical center. Patients with ACS,who met the conditions and agreed to join the study will be recruited. Then,the informed consent will be obtained. At the first stage, 10subjects will be collect. At the secondary stage, a total of 104 subjects will be enrolled, 52 in the experimental group will receive the self-management program, and 52 in the control group will receive a routine hospital care.
Method \& Results:
The data of demographic and disease characteristics, clinical indicators,depression, anxiety, self-management, and quality of life will be collected.The Hospital Anxiety and Depression Scale, the SF-36 Taiwan version of the Quality-of-Life Questionnaire and the Self-Management Scale will used as tools to collect data. The efficacy of the intervention will be collected 1 month and 3 months after the intervention. Data will be statistically analyzed by GEE.
Hypothesis :
It is expected that the self-management program applied to patients with ACS can reduce depression and anxiety, thereby improving the quality of life.
This study the first phase is to construct and develop interventional measures for self-management of patients with ACS. According to the associated factors of study, the intervention measures are designed based on self-management. A pilot study will be conducted to improve research and to develop better selfmanagement interventions in the future. At the secondary stage: a randomized controlled trial with a random sampling design is used to investigate the effects of self-management programs on anxiety, depression, and quality of life in patients with ACS. The study will conduct in a cardiac medicine ward or coronary intensive care center of a north medical center. Patients with ACS,who met the conditions and agreed to join the study will be recruited. Then,the informed consent will be obtained. At the first stage, 10subjects will be collect. At the secondary stage, a total of 104 subjects will be enrolled, 52 in the experimental group will receive the self-management program, and 52 in the control group will receive a routine hospital care.
Method \& Results:
The data of demographic and disease characteristics, clinical indicators,depression, anxiety, self-management, and quality of life will be collected.The Hospital Anxiety and Depression Scale, the SF-36 Taiwan version of the Quality-of-Life Questionnaire and the Self-Management Scale will used as tools to collect data. The efficacy of the intervention will be collected 1 month and 3 months after the intervention. Data will be statistically analyzed by GEE.
Hypothesis :
It is expected that the self-management program applied to patients with ACS can reduce depression and anxiety, thereby improving the quality of life.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: