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

NCT04438356 | Completed

• 1 other identifier: M-Health Care for AMI Patients
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  T3-six months later

• Cardio-Respiratory Fitness-T1

  Six-Minutes Walking Test, 6MWT

  T1-baseline

• Cardio-Respiratory Fitness-T2

  Six-Minutes Walking Test, 6MWT

  T2-three months later

• Cardio-Respiratory Fitness-T3

  Six-Minutes Walking Test, 6MWT

  T3-six months later

Study Arms (2)

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?

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?

Combination Product: M-Health

Interventions

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.

M-health; wait list control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

TSGH

Taipei, Taiwan

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

American Recovery and Reinvestment Act

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Legislation as Topic; Social Control, Formal; Health Care Economics and Organizations

Study Officials

• Hui-Hsun Chiang, PhD

  National Defense Medical College, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: wait list control group RCT

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: July 22, 2020
• Primary Completion: March 20, 2022
• Study Completion: March 20, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)