Clinical trial NCT05999695: Self-management of Patients With Acute Coronary Syndromes
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: self-management
acute coronary syndrome
anxiety
depression
quality of life
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-08-21
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale, HADS
timeFrame: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge.
measure: The MOS 36-Item Short-Form Health Survey,SF36
timeFrame: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge
measure: The Partner In Health scale, PIH
timeFrame: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county,
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Hui-Chuan Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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