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Self-management of Patients With Acute Coronary Syndromes

Primary Purpose

Acute Coronary Syndromes

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
self-management
regular care
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Coronary Syndromes focused on measuring self-management, acute coronary syndrome, anxiety, depression, quality of life

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

self-management interventions

regular care

Arm 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

regular care

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2023
Last Updated
August 11, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05999695
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 11, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
self-management, acute coronary syndrome, anxiety, depression, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
self-management interventions
Arm Type
Experimental
Arm 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
Arm Title
regular care
Arm Type
Active Comparator
Arm Description
regular care
Intervention Type
Other
Intervention Name(s)
self-management
Intervention Description
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
Intervention Name(s)
regular care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale, HADS
Description
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.
Time Frame
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.
Title
The MOS 36-Item Short-Form Health Survey,SF36
Description
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.
Time Frame
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
Title
The Partner In Health scale, PIH
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Cheng
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei county,
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
result

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Self-management of Patients With Acute Coronary Syndromes

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