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Clinical Trials/NCT04438356
NCT04438356
Completed
Not Applicable

Effects of Mobile Health Care for Patients After Acute Myocardial Infarction on Disease Perception, Self-Efficacy, Anxiety and Cardio-Respiratory Fitness: A Randomized Controlled Trial

National Defense Medical Center, Taiwan1 site in 1 country31 target enrollmentJuly 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mobile Health
Sponsor
National Defense Medical Center, Taiwan
Enrollment
31
Locations
1
Primary Endpoint
Disease Perception-T1
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study is to explore the overall effectiveness of interventions using mobile health care to improve disease perception, self-efficacy, anxiety, cardio-pulmonary fitness for patients with acute myocardial infarction.

Detailed Description

Heart disease is the second leading cause of death in Taiwan. Coronary artery disease (CAD) is the majority, and coronary artery disease is the most common cardiovascular disease. There is an increase, and it is no longer just that the elderly is the predominant group. There is a tendency to gradually become younger. In foreign countries, coronary heart disease is also one of the main causes of patient death and disability, resulting in huge medical burdens and costs. Coronary heart disease also includes acute myocardial infarction, which causes myocardial cell death due to unstable myocardial ischemia. Sudden heart disease brings unexpected shock, fear, and despair to patients and their families. Therefore, patient self-management is very important. It also improves the patient's quality of life. Post-acute myocardial infarction patients are susceptible to piecemeal information and lack the motivation to change their life style, continue to maintain smoking behavior and do not engage in exercise, leading to the recurrence of major coronary artery problems. In order to reduce secondary cardiovascular problems, it is necessary to rely on the patient's own knowledge of the disease, self-care behavior and self-efficacy, including diet, exercise, etc., so that the disease can be controlled and treated, and also need to monitor and adjust the physical and mental state to reduce subsequent problems caused by anxiety. Therefore, in order to provide multi-party support for patients' self-health care, mobile health care such as mobile phone text messages, applications, and remote monitoring are gradually emerging. Therefore, it is expected that the use of mHealth can be used to develop two-way communication and interaction and a higher message reception rate to stimulate acuteness. After myocardial infarction, patients can change their motivations for self-health care behaviors to achieve more efficient disease perception, self-efficacy, anxiety and cardiopulmonary fitness, and have a longer-term influence ability.

Registry
clinicaltrials.gov
Start Date
July 22, 2020
End Date
March 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Defense Medical Center, Taiwan
Responsible Party
Principal Investigator
Principal Investigator

Hui-Hsun Chiang

Associate Professor

National Defense Medical Center, Taiwan

Eligibility Criteria

Inclusion Criteria

  • Taiwanese, understand Chinese
  • Patients who are over 20 years old and have AMI (including ST segment ascending and non-ST segment ascending), diagnosed by percutaneous coronary intervention and without complications within 30±5 days, the left ventricular injection rate is greater than 40% .
  • Ability and willingness to provide informed consent.
  • Have a smartphone.
  • Can receive and send smartphone messages.

Exclusion Criteria

  • Those who can't express their wishes clearly (such as mental dysfunction)
  • mental disorder
  • Patients who participate in other research projects
  • Planned coronary artery bypass surgery or other diseases that require continuous heart care.
  • Abuse of alcohol or narcotics.
  • Left ventricular ejection fraction (LVEF) is less than 40%.

Outcomes

Primary Outcomes

Disease Perception-T1

Time Frame: T1-baseline

The Brief Illness Perception Questionnaire(The B-IPQ) have nine questions on the scale. The first eight questions use a response level of 0 to 10. The ninth question is an open question and answer. The patient is asked to list the three most important causes of the disease. The higher the total score, the greater the threat to the disease.

Disease Perception-T2

Time Frame: T2-three months later

The Brief Illness Perception Questionnaire(The B-IPQ) have nine questions on the scale. The first eight questions use a response level of 0 to 10. The ninth question is an open question and answer. The patient is asked to list the three most important causes of the disease. The higher the total score, the greater the threat to the disease.

Disease Perception-T3

Time Frame: T3-six months later

The Brief Illness Perception Questionnaire(The B-IPQ) have nine questions on the scale. The first eight questions use a response level of 0 to 10. The ninth question is an open question and answer. The patient is asked to list the three most important causes of the disease. The higher the total score, the greater the threat to the disease.

Self-Efficacy-T1

Time Frame: T1-baseline

Cardiac Self-Efficacy Scale have 13 questions in total. The higher the total score, the higher the patient's confidence in dealing with their own heart disease.

Self-Efficacy-T2

Time Frame: T2-three months later

Cardiac Self-Efficacy Scale have 13 questions in total. The higher the total score, the higher the patient's confidence in dealing with their own heart disease.

Self-Efficacy-T3

Time Frame: T3-six months later

Cardiac Self-Efficacy Scale have 13 questions in total. The higher the total score, the higher the patient's confidence in dealing with their own heart disease.

Anxiety-T2

Time Frame: T2-three months later

Beck Anxiety Inventory(BAI) have 21 questions in total. Each question is evaluated with 0-3 points for its severity, with a score of 0- 9 points are normal, 10-18 points are mild anxiety, 19-29 points are moderate anxiety, and 30 points or more are severe anxiety.

Anxiety-T3

Time Frame: T3-six months later

Beck Anxiety Inventory(BAI) have 21 questions in total. Each question is evaluated with 0-3 points for its severity, with a score of 0- 9 points are normal, 10-18 points are mild anxiety, 19-29 points are moderate anxiety, and 30 points or more are severe anxiety.

Cardio-Respiratory Fitness-T1

Time Frame: T1-baseline

Six-Minutes Walking Test, 6MWT

Cardio-Respiratory Fitness-T2

Time Frame: T2-three months later

Six-Minutes Walking Test, 6MWT

Cardio-Respiratory Fitness-T3

Time Frame: T3-six months later

Six-Minutes Walking Test, 6MWT

Anxiety-T1

Time Frame: T1-baseline

Beck Anxiety Inventory(BAI) have 21 questions in total. Each question is evaluated with 0-3 points for its severity, with a score of 0- 9 points are normal, 10-18 points are mild anxiety, 19-29 points are moderate anxiety, and 30 points or more are severe anxiety.

Study Sites (1)

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