Clinical trial NCT04438356: M-Health Care for Patients After AMI on Disease Perception, Self-Efficacy, Anxiety and Cardio-Respiratory Fitness
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile Health
Acute Myocardial Infarction
Undefined
Self-efficacy
Anxiety
Cardio-respiratory Fitness
Keywords: Mobile Health
self-efficacy
disease perception
Anxiety
cardio-respiratory fitness
Remote Care
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: wait list control group RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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%.

Primary outcomes:
measure: Disease Perception-T1
timeFrame: T1-baseline
measure: Disease Perception-T2
timeFrame: T2-three months later
measure: Disease Perception-T3
timeFrame: T3-six months later
measure: Self-Efficacy-T1
timeFrame: T1-baseline
measure: Self-Efficacy-T2
timeFrame: T2-three months later
measure: Self-Efficacy-T3
timeFrame: T3-six months later
measure: Anxiety-T1
timeFrame: T1-baseline
measure: Anxiety-T2
timeFrame: T2-three months later
measure: Anxiety-T3
timeFrame: T3-six months later
measure: Cardio-Respiratory Fitness-T1
timeFrame: T1-baseline
measure: Cardio-Respiratory Fitness-T2
timeFrame: T2-three months later
measure: Cardio-Respiratory Fitness-T3
timeFrame: T3-six months later
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: TSGH
Study officials:
affiliation: National Defense Medical College, Japan
name: Hui-Hsun Chiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: