Self-management of Patients With Acute Coronary Syndromes

NCT ID: NCT05999695

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-11
• Study Completion Date: 2024-08-26

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).

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.

Conditions

Acute Coronary Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

self-management interventions

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

Group Type: EXPERIMENTAL

self-management

Intervention Type: OTHER

The experimental group received the "SelfManagement Program for Acute Coronary Syndrome":

the research subjects completed the first data collection within one week of hospitalization. Guide the research subjects to browse this manual and watch the "Acute Coronary Self-Care Video", and explain what they do not understand, hoping to stimulate the research subjects to discuss nursing issues, and jointly formulate self-management goals, and This handbook was given to study subjects to take home. Telephone interviews every 2 weeks in the first month after discharge, and then again after two and three months after discharge. Each call is about 10 minutes to track the completion of goals and self-management,including usual medication, regular exercise, balance Food and spiritual support and encouragement, etc.,and clarify any doubts.

regular care

Intervention Type: OTHER

gular care regular care The nurse implements routine nursing instructions, including disease and treatment profiles,symptom management, and outpatient follow-up. Scan the QRC with your mobile phone or provide the "Care Guidance Leaflet for Coronary Artery Disease" and "Caring for Myocardial Infarction Patients" which are all written in text.

regular care

regular care

Group Type: ACTIVE_COMPARATOR

regular care

Intervention Type: OTHER

gular care regular care The nurse implements routine nursing instructions, including disease and treatment profiles,symptom management, and outpatient follow-up. Scan the QRC with your mobile phone or provide the "Care Guidance Leaflet for Coronary Artery Disease" and "Caring for Myocardial Infarction Patients" which are all written in text.

Interventions

self-management

The experimental group received the "SelfManagement Program for Acute Coronary Syndrome":

the research subjects completed the first data collection within one week of hospitalization. Guide the research subjects to browse this manual and watch the "Acute Coronary Self-Care Video", and explain what they do not understand, hoping to stimulate the research subjects to discuss nursing issues, and jointly formulate self-management goals, and This handbook was given to study subjects to take home. Telephone interviews every 2 weeks in the first month after discharge, and then again after two and three months after discharge. Each call is about 10 minutes to track the completion of goals and self-management,including usual medication, regular exercise, balance Food and spiritual support and encouragement, etc.,and clarify any doubts.

Intervention Type: OTHER

regular care

gular care regular care The nurse implements routine nursing instructions, including disease and treatment profiles,symptom management, and outpatient follow-up. Scan the QRC with your mobile phone or provide the "Care Guidance Leaflet for Coronary Artery Disease" and "Caring for Myocardial Infarction Patients" which are all written in text.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Cheng, Hui- Chuan

Nursing Supervisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui-Chuan Cheng

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei County,, , Taiwan

Countries

Taiwan

References

Bandura, A. (1977). Self-efficacy: toward a unifying theory of behavioral change. Psychological Review, 84(2), 191-215. https:// doi.org/10.1037//0033-295x.84.2.191 Gach, O., El, H. Z., & Lancellotti, P.(2018). [Acute coronary syndrome]. Revue Médicale de Liège, 73(5-6),243-250. (Syndrome coronarien aigu.) Guo, P., & Harris, R. (2016). The effectiveness and experience of self-management following acute coronary syndrome: A review of the literature. International Journal of Nursing Studies,61, 29-51. https://doi.org/10.1016/j.ijnurstu.2016.05.008 Hong, P. C., Chen,K. J., Chang, Y. C., Cheng, S. M., & Chiang, H. H. (2021). Effectiveness of Theory-Based Health Information Technology Interventions on Coronary Artery Disease Self-Management Behavior: A Clinical Randomized Waitlist-Controlled Trial. Journal of Nursing Scholarship, 53(4), 418-427. https://doi.org/10.1111/ jnu.12661

Reference Type: RESULT

Other Identifiers

2022-08-003C

Identifier Type: -

Identifier Source: org_study_id