Mobile HealthNCT04438356
M-Health Care for Patients After AMI on Disease Perception, Self-Efficacy, Anxiety and Cardio-Respiratory Fitness
A study testing M-Health in people with Mobile Health and Acute Myocardial Infarction, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mobile Health, Acute Myocardial Infarction, Undefined
- What is being tested?
- M-Health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jul 2020to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mobile Health, Acute Myocardial Infarction, Undefined, Self-efficacy, Anxiety, Cardio-respiratory Fitness
- Being tested
- M-Health
- Keywords
- Mobile Health, self-efficacy, disease perception, Anxiety, cardio-respiratory fitness, Remote Care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-HealthCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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? Receives: Combination Product: M-Health |
| 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? Receives: Combination Product: M-Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1-baseline
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.
Measured: T2-three months later
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.
Measured: T3-six months later
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.
Measured: T1-baseline
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.
Measured: T2-three months later
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.
Measured: T3-six months later
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.
Measured: T1-baseline
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.
Measured: T2-three months later
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.
Measured: T3-six months later
Cardio-Respiratory Fitness-T1
Six-Minutes Walking Test, 6MWT
Measured: T1-baseline
Cardio-Respiratory Fitness-T2
Six-Minutes Walking Test, 6MWT
Measured: T2-three months later
Cardio-Respiratory Fitness-T3
Six-Minutes Walking Test, 6MWT
Measured: T3-six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start22 Jul 2020
- Primary completion20 Mar 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- wait list control group RCT
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Hsun Chiang, National Defense Medical Center, Taiwan
- Investigators
- Hui-Hsun Chiang, PhD, Principal investigator, National Defense Medical College, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438356
- Sponsor's protocol ID
- M-Health Care for AMI Patients
- Status last verified
- Sep 2022
- First submitted
- 16 Jun 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04438356
- Acronym / sponsor ID
- M-Health Care for AMI Patients
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- wait list control group RCT
| Arm | Type | Receives |
|---|---|---|
| M-health | Experimental | Combination Product: M-HealthAfter 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 | Experimental | Combination Product: M-Healthwait 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? |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-HealthThe 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. | Combination product | M-health, wait list control |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cardio-Respiratory Fitness-T1
Time frame: T1-baseline
Six-Minutes Walking Test, 6MWT
Cardio-Respiratory Fitness-T2
Time frame: T2-three months later
Six-Minutes Walking Test, 6MWT
Cardio-Respiratory Fitness-T3
Time frame: T3-six months later
Six-Minutes Walking Test, 6MWT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Mobile Health
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Mobile Game-Based Versus Classic First Aid Education in Adolescents: Randomized Controlled Trial
First Aid, Health Education in Schoolchildren
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Hsun Chiang, PhD principal investigator
National Defense Medical College, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-Health in people with Mobile Health and Acute Myocardial Infarction, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Perception-T1 (time frame: T1-baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.