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Self-management of Patients With Acute Coronary Syndromes

T

Taipei Veterans General Hospital

Status

Invitation-only

Conditions

Acute Coronary Syndromes

Treatments

Other: regular care
Other: self-management

Study type

Interventional

Funder types

Other

Identifiers

NCT05999695
2022-08-003C

Details and patient eligibility

About

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).

Full 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.

Enrollment

104 estimated patients

Sex

All

Ages

20 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Over 20 years old
  • The first diagnosis of acute coronary syndrome by a clinician,
  • Clear consciousness, able to converse in Chinese and Taiwanese languages.
  • Willingness to participate in this research

Exclusion criteria

  • Those who are unable to take care of themselves
  • Poor vision and inability to read
  • Hard of hearing and deafness
  • Inability to communicate

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

104 participants in 2 patient groups

self-management interventions
Experimental group
Description:
self-management interventions: According to the results of literature search and based on the theory of self-efficacy, the intervention measures of the self-management program were designed. regular care:regular care
Treatment:
Other: regular care
Other: self-management
regular care
Active Comparator group
Description:
regular care
Treatment:
Other: regular care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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