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临床试验/NCT04438356
NCT04438356已完成不适用

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 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Disease Perception-T1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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%.

研究组 & 干预措施

M-health

Experimental

After the acute myocardial infarction, patients will be randomly assigned to the intervention group. Give the intervention group mobile health care programs and given Garmin monitoring hands ring. In order to give patients clear walking goals and exercise intensity, the intervention group will use the Mobile Health Medical Line app to remind patients of the walking frequency and time, and use Garmin monitoring bracelet to record the patient's daily walking steps. The Mobile Health Medical Line app content includes: 1. Encourage the walking exercise to perform 2. Give them knowledge about acute myocardial infarction 3. How to self-care themselves 4. How to release their anxiety?

干预措施: M-Health (Combination Product)

wait list control

Experimental

wait list control for 3 months and then use the Mobile Health Medical Line app to remind patients of the walking frequency and time, and use Garmin monitoring bracelet to record the patient's daily walking steps. The Mobile Health Medical Line app content includes: 1. Encourage the walking exercise to perform 2. Give them knowledge about acute myocardial infarction 3. How to self-care themselves 4. How to release their anxiety?

干预措施: M-Health (Combination Product)

结局指标

主要结局

Disease Perception-T1

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: T1-baseline

Six-Minutes Walking Test, 6MWT

Cardio-Respiratory Fitness-T2

时间窗: T2-three months later

Six-Minutes Walking Test, 6MWT

Cardio-Respiratory Fitness-T3

时间窗: T3-six months later

Six-Minutes Walking Test, 6MWT

Anxiety-T1

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui-Hsun Chiang

Associate Professor

National Defense Medical Center, Taiwan

研究点 (1)

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