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

Primary Purpose

Mobile Health, Acute Myocardial Infarction, Undefined

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
M-Health
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mobile Health focused on measuring Mobile Health, self-efficacy, disease perception, Anxiety, cardio-respiratory fitness, Remote Care

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • TSGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

M-health

wait list control

Arm Description

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?

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?

Outcomes

Primary Outcome Measures

Disease Perception-T1
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
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
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
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
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
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-T1
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-T2
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
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
Six-Minutes Walking Test, 6MWT
Cardio-Respiratory Fitness-T2
Six-Minutes Walking Test, 6MWT
Cardio-Respiratory Fitness-T3
Six-Minutes Walking Test, 6MWT

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
September 26, 2022
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04438356
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
March 20, 2022 (Actual)
Study Completion Date
March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
wait list control group RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M-health
Arm Type
Experimental
Arm Description
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?
Arm Title
wait list control
Arm Type
Experimental
Arm Description
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?
Intervention Type
Combination Product
Intervention Name(s)
M-Health
Intervention Description
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 Outcome Measure Information:
Title
Disease Perception-T1
Description
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.
Time Frame
T1-baseline
Title
Disease Perception-T2
Description
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.
Time Frame
T2-three months later
Title
Disease Perception-T3
Description
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.
Time Frame
T3-six months later
Title
Self-Efficacy-T1
Description
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.
Time Frame
T1-baseline
Title
Self-Efficacy-T2
Description
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.
Time Frame
T2-three months later
Title
Self-Efficacy-T3
Description
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.
Time Frame
T3-six months later
Title
Anxiety-T1
Description
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.
Time Frame
T1-baseline
Title
Anxiety-T2
Description
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.
Time Frame
T2-three months later
Title
Anxiety-T3
Description
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.
Time Frame
T3-six months later
Title
Cardio-Respiratory Fitness-T1
Description
Six-Minutes Walking Test, 6MWT
Time Frame
T1-baseline
Title
Cardio-Respiratory Fitness-T2
Description
Six-Minutes Walking Test, 6MWT
Time Frame
T2-three months later
Title
Cardio-Respiratory Fitness-T3
Description
Six-Minutes Walking Test, 6MWT
Time Frame
T3-six months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Hsun Chiang, PhD
Organizational Affiliation
National Defense Medical College, Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
TSGH
City
Taipei city
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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