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Completed

NCT Number: NCT04438356

M-Health Care for Patients After AMI on Disease Perception, Self-Efficacy, Anxiety and Cardio-Respiratory Fitness

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.

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Key information

Conditions

Mobile Health Acute Myocardial Infarction Anxiety Anxiety Disorders Cardio-respiratory Fitness Mental Disorders Self-Efficacy Undefined

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TSGH

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

M-Health

Combination Product

The study was randomized (wait-list-control), and it was estimated that 80 subjects were randomly assigned to the immediate treatment group and the wait-list-control group. The two groups were tested for baseline before intervention in the mHealth. After the first questionnaire evaluation, the experimental group was involved in the mHealth for three months, and after three months, the experimental group and the waiting intervention control group were post-tested. To assess the effectiveness of the two groups before and after the mHealth . Control group that waits for intervention in the fourth month from the beginning of the fourth month to the end of the sixth month.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Cardio-Respiratory Fitness-T1

    Time frame: T1-baseline

    Six-Minutes Walking Test, 6MWT

  11. Cardio-Respiratory Fitness-T2

    Time frame: T2-three months later

    Six-Minutes Walking Test, 6MWT

  12. Cardio-Respiratory Fitness-T3

    Time frame: T3-six months later

    Six-Minutes Walking Test, 6MWT

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2020
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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