Self-management of Patients With Acute Coronary Syndromes

NCT05999695 | Enrolling By Invitation

• 1 other identifier: 2022-08-003C
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Coronary Syndromes

Keywords

self-management; acute coronary syndrome; anxiety; depression; quality of life

Outcome Measures

Primary Outcomes (3)

• Hospital Anxiety and Depression Scale, HADS

  The Likert four-point scale (0-3 points) was used, and the two items were scored separately, and the total score was between 0-21 points. The higher the score, the higher the degree of anxiety or depression. A score below 7 means no anxiety or depression, a score between 8 and 10 means the patient is suspected of anxiety or depression, and a score greater than or equal to 11 means that the patient has anxiety or depression. It is a measure to assess change at three-time points. change from Baseline Anxiety and Depression at 1 and 3 months.

  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.

• The MOS 36-Item Short-Form Health Survey,SF36

  Scores range from 0 to 100, with higher scores indicating better self-assessed health. Each item of the questionnaire is calculated separately according to the designed initial scores. Then the scores of the items related to each scale are added up and then subtracted from each scale to obtain the lowest score. Divide by the distance between the possible scores of each scale, and multiply by 100 to get the score. It is a measure to assess change at three-time points. change from Baseline quality of life at 1 and 3 months.

  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

• The Partner In Health scale, PIH

  Items in the scale are graded on a nine-point scale, with 0 representing the worst and 8 representing the best. This is a closed and continuous variable. The scale scores range from 0 to 96, with higher scores indicating better selfmanagement. It is a measure to assess change at three-time points. Change from self-management Baseline at 1 and 3 months.

  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

Study Arms (2)

self-management interventions

EXPERIMENTAL

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

Other: self-management; Other: regular care

regular care

ACTIVE COMPARATOR

regular care

Other: regular care

Interventions

self-management 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.

self-management interventions

regular care 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; self-management interventions

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei County,, 112, Taiwan

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; Anxiety Disorders; Depression

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hui-Chuan Cheng

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Supervisor

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: December 11, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 26, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)