Self-management of Patients With Acute Coronary Syndromes

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05999695
Collaborator
(none)
104
1
2
12.7
8.2

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: self-management
  • Other: regular care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
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.
Actual Study Start Date :
Dec 11, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: 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.

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.

Active Comparator: regular care

regular care

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.

Outcome Measures

Primary Outcome Measures

  1. Hospital Anxiety and Depression Scale, HADS [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 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.

  2. The MOS 36-Item Short-Form Health Survey,SF36 [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]

    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.

  3. The Partner In Health scale, PIH [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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Veterans General Hospital Taipei county, Taiwan 112

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Hui-Chuan Cheng, Taipei Veterans General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cheng, Hui- Chuan, Nursing Supervisor, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT05999695
Other Study ID Numbers:
  • 2022-08-003C
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cheng, Hui- Chuan, Nursing Supervisor, Taipei Veterans General Hospital, Taiwan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023