<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04438356</url>
  </required_header>
  <id_info>
    <org_study_id>M-Health Care for AMI Patients</org_study_id>
    <nct_id>NCT04438356</nct_id>
  </id_info>
  <brief_title>M-Health Care for Patients After AMI on Disease Perception, Self-Efficacy, Anxiety and Cardio-Respiratory Fitness</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Defense Medical Center, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Defense Medical Center, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to explore the overall effectiveness of interventions using mobile&#xD;
      health care to improve disease perception, self-efficacy, anxiety, cardio-pulmonary fitness&#xD;
      for patients with acute myocardial infarction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart disease is the second leading cause of death in Taiwan. Coronary artery disease (CAD)&#xD;
      is the majority, and coronary artery disease is the most common cardiovascular disease. There&#xD;
      is an increase, and it is no longer just that the elderly is the predominant group. There is&#xD;
      a tendency to gradually become younger. In foreign countries, coronary heart disease is also&#xD;
      one of the main causes of patient death and disability, resulting in huge medical burdens and&#xD;
      costs. Coronary heart disease also includes acute myocardial infarction, which causes&#xD;
      myocardial cell death due to unstable myocardial ischemia. Sudden heart disease brings&#xD;
      unexpected shock, fear, and despair to patients and their families. Therefore, patient&#xD;
      self-management is very important. It also improves the patient's quality of life.&#xD;
&#xD;
      Post-acute myocardial infarction patients are susceptible to piecemeal information and lack&#xD;
      the motivation to change their life style, continue to maintain smoking behavior and do not&#xD;
      engage in exercise, leading to the recurrence of major coronary artery problems. In order to&#xD;
      reduce secondary cardiovascular problems, it is necessary to rely on the patient's own&#xD;
      knowledge of the disease, self-care behavior and self-efficacy, including diet, exercise,&#xD;
      etc., so that the disease can be controlled and treated, and also need to monitor and adjust&#xD;
      the physical and mental state to reduce subsequent problems caused by anxiety. Therefore, in&#xD;
      order to provide multi-party support for patients' self-health care, mobile health care such&#xD;
      as mobile phone text messages, applications, and remote monitoring are gradually emerging.&#xD;
      Therefore, it is expected that the use of mHealth can be used to develop two-way&#xD;
      communication and interaction and a higher message reception rate to stimulate acuteness.&#xD;
      After myocardial infarction, patients can change their motivations for self-health care&#xD;
      behaviors to achieve more efficient disease perception, self-efficacy, anxiety and&#xD;
      cardiopulmonary fitness, and have a longer-term influence ability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">March 20, 2022</completion_date>
  <primary_completion_date type="Actual">March 20, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>wait list control group RCT</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease Perception-T1</measure>
    <time_frame>T1-baseline</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Perception-T2</measure>
    <time_frame>T2-three months later</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Perception-T3</measure>
    <time_frame>T3-six months later</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy-T1</measure>
    <time_frame>T1-baseline</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy-T2</measure>
    <time_frame>T2-three months later</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy-T3</measure>
    <time_frame>T3-six months later</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety-T1</measure>
    <time_frame>T1-baseline</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety-T2</measure>
    <time_frame>T2-three months later</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety-T3</measure>
    <time_frame>T3-six months later</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardio-Respiratory Fitness-T1</measure>
    <time_frame>T1-baseline</time_frame>
    <description>Six-Minutes Walking Test, 6MWT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardio-Respiratory Fitness-T2</measure>
    <time_frame>T2-three months later</time_frame>
    <description>Six-Minutes Walking Test, 6MWT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardio-Respiratory Fitness-T3</measure>
    <time_frame>T3-six months later</time_frame>
    <description>Six-Minutes Walking Test, 6MWT</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Mobile Health</condition>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Undefined</condition>
  <condition>Self-efficacy</condition>
  <condition>Anxiety</condition>
  <condition>Cardio-respiratory Fitness</condition>
  <arm_group>
    <arm_group_label>M-health</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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?</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wait list control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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?</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>M-Health</intervention_name>
    <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.</description>
    <arm_group_label>M-health</arm_group_label>
    <arm_group_label>wait list control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Taiwanese, understand Chinese&#xD;
&#xD;
          -  Patients who are over 20 years old and have AMI (including ST segment ascending and&#xD;
             non-ST segment ascending), diagnosed by percutaneous coronary intervention and without&#xD;
             complications within 30±5 days, the left ventricular injection rate is greater than&#xD;
             40% .&#xD;
&#xD;
          -  Ability and willingness to provide informed consent.&#xD;
&#xD;
          -  Have a smartphone.&#xD;
&#xD;
          -  Can receive and send smartphone messages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who can't express their wishes clearly (such as mental dysfunction)&#xD;
&#xD;
          -  mental disorder&#xD;
&#xD;
          -  Patients who participate in other research projects&#xD;
&#xD;
          -  Planned coronary artery bypass surgery or other diseases that require continuous heart&#xD;
             care.&#xD;
&#xD;
          -  Abuse of alcohol or narcotics.&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) is less than 40%.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui-Hsun Chiang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Defense Medical College, Japan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TSGH</name>
      <address>
        <city>Taipei city</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Defense Medical Center, Taiwan</investigator_affiliation>
    <investigator_full_name>Hui-Hsun Chiang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Mobile Health</keyword>
  <keyword>self-efficacy</keyword>
  <keyword>disease perception</keyword>
  <keyword>Anxiety</keyword>
  <keyword>cardio-respiratory fitness</keyword>
  <keyword>Remote Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04438356
org study id: M-Health Care for AMI Patients
nct id: NCT04438356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: wait list control group RCT
primary purpose: Health Services Research
masking: None (Open Label)
measure: Disease Perception-T1
time frame: T1-baseline
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.
measure: Disease Perception-T2
time frame: T2-three months later
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.
measure: Disease Perception-T3
time frame: T3-six months later
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.
measure: Self-Efficacy-T1
time frame: T1-baseline
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.
measure: Self-Efficacy-T2
time frame: T2-three months later
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.
measure: Self-Efficacy-T3
time frame: T3-six months later
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.
measure: Anxiety-T1
time frame: T1-baseline
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.
measure: Anxiety-T2
time frame: T2-three months later
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.
measure: Anxiety-T3
time frame: T3-six months later
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.
measure: Cardio-Respiratory Fitness-T1
time frame: T1-baseline
description: Six-Minutes Walking Test, 6MWT
measure: Cardio-Respiratory Fitness-T2
time frame: T2-three months later
description: Six-Minutes Walking Test, 6MWT
measure: Cardio-Respiratory Fitness-T3
time frame: T3-six months later
description: Six-Minutes Walking Test, 6MWT
arm group label: M-health
arm group type: Experimental
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 group label: wait list control
arm group type: Experimental
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: M-Health
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.
arm group label: M-health
arm group label: wait list control
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hui-Hsun Chiang, PhD
role: Principal Investigator
affiliation: National Defense Medical College, Japan
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Defense Medical Center, Taiwan
investigator full name: Hui-Hsun Chiang
investigator title: Associate Professor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Anxiety Disorders
sharing ipd: No