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Acute Coronary Syndrome/ Myocardial InfarctionNCT07390006

Enabling Patient-Reported Outcomes Through Innovative Care - ACS (EPIC-ACS)

A study testing Innovative Care Approach and Usual Post-Acute Coronary Syndrome Care in people with Acute Coronary Syndrome/ Myocardial Infarction and Coronary Artery Disease, run by Mahidol University at 1 site in Thailand.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study evaluates the effectiveness of an innovative care approach that integrates face-to-face education, motivational counseling, and mobile health (mHealth) support delivered via the LINE application among Thai older adults following acute coronary syndrome (ACS) treated with percutaneous coronary intervention… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Innovative Care Approach and Usual Post-Acute Coronary Syndrome Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteThailand
Study dates
10 Mar 2026to 10 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 60 years old.
  • Diagnosed with ACS and received PCI within 3-12 months.
  • Being familiar with using a smartphone or tablet with the LINE application, either personally or through a caregiver or family member.
  • No cognitive impairment assessed by the 6-Item Cognitive Function Test-Thai Version (6CIT), score less than 8.
  • Able to communicate in the Thai language by speaking, listening, reading, and writing in Thai sufficiently.
  • Voluntarily agreed to participate and has signed the informed consent form.
Show all 9Show fewer
  • Participate in the experimental group and complete the program.
  • Extreme case sampling involves selecting the top 6 highest and top 6 lowest scores for healthy behavior.
  • Willing to participate in a one-on-one in-depth interview.

Who cannot join

  • Have clinical contraindications to physical exercise (i.e. unstable angina, uncontrolled arrhythmias, systolic >180 mmHg or diastolic >110 mmHg, an LVEF of less than 40%, recent major surgery within 12 weeks such as CABG, valve replacement, or orthopedic surgery), or any serious medical condition that the cardiologist considers unsafe to perform physical activity.
  • Visual or hearing impairments that cannot be adequately managed with medical devices (e.g., eyeglasses or hearing aids) and that interfere with the ability to participate in study activities or communicate effectively.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jamchan Prateepmanowong, PhD contact

+666 3514 2445

Jamchan.pra@student.mahidol.ac.th

Suparb Aree-Ue, PhD contact

+669 5459 1549

Suparb.are@mahidol.ac.th

Thailand1 site
  • Faculty of Medicine Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

    Krissada Meemook, MD, +668 1913 7282, Krissada.mee@mahidol.ac.th

    Jamchan Prateepmanowong, PhD, +666 3514 2445, Jamchan.pra@student.mahidol.ac.th

Other trials in Thailand

About this study

Official title: Enabling Patient-Reported Outcomes Through Innovative Care Approach in Thai Older Adults Post-Acute Coronary Syndrome: A Mixed Methods Experimental Design

This study evaluates the effectiveness of an innovative care approach that integrates face-to-face education, motivational counseling, and mobile health (mHealth) support delivered via the LINE application among Thai older adults following acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). The intervention aims to support post-discharge recovery by promoting healthy behaviors, improving health status, and enhancing patient satisfaction with care.

The primary objective is to assess the effect of the intervention on patient-reported outcomes, including healthy behaviors, health status, and patient satisfaction. Secondary objectives include evaluating unplanned hospital visits during a 12-week follow-up period and exploring participants' experiences, motivation, and engagement with the innovative care approach.

Read the detailed description

This is a single-site, mixed-methods experimental study designed to evaluate the effectiveness of an innovative care approach among older adults following acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). The intervention integrates structured face-to-face education and skill-building sessions, individualized motivational counseling, and mobile health (mHealth) support delivered via the LINE application.

The quantitative component is a parallel-group, superiority randomized controlled trial with repeated measures. Eighty participants will be enrolled and randomly assigned in a 1:1 ratio to either the intervention group (innovative nurse-led care approach) or the control group (usual post-ACS care). Randomization will occur after baseline assessment using a computer-generated sequence with allocation concealment, and analyses will follow the intention-to-treat principle.

The intervention will be delivered over a 12-week period. Quantitative assessments of patient-reported outcomes will be conducted at baseline, week 8, and week 12. The qualitative component will use a post-intervention descriptive design, with in-depth interviews conducted between weeks 13 and 16 among a subset of intervention participants to explore experiences, perceived benefits, motivation, and engagement. A sequential explanatory mixed-methods approach will be used to contextualize quantitative findings with qualitative insights.

Quantitative data will be analyzed using descriptive statistics and generalized estimating equations to assess longitudinal changes over time and between groups. Unplanned hospital visits during the follow-up period will be analyzed using appropriate regression models for count data. Qualitative data will be analyzed using thematic analysis, and integration of findings will occur during interpretation.

The study has received institutional ethics approval. Written informed consent will be obtained from all participants, and confidentiality and data security will be maintained throughout the study.

Being tested
Innovative Care Approach, Usual Post-Acute Coronary Syndrome Care
Keywords
Acute Coronary Syndrome, Mobile Health, Nurse-led Counseling, Patient Reported Outcome, Older Adult
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Innovative Care ApproachBehavioural

    A nurse-led behavioral intervention including structured education, motivational counseling, and mobile health (mHealth) support delivered via the LINE application over 12 weeks.

  • Usual Post-Acute Coronary Syndrome CareOther

    Standard post-acute coronary syndrome care provided according to routine clinical practice.

Study groups in NCT07390006
Study groupRoleWhat they receive
Arm 1: Intervention Group - Innovative Care ApproachExperimentalParticipants randomized to the intervention group will receive an innovative care approach in addition to usual post-acute coronary syndrome (ACS) care. The intervention includes a structured face-to-face education and skill-building session, provision of the Healthy Heart Booklet and motivational posters, and individualized motivational counseling focused on promoting healthy behaviors. Participants will also receive ongoing mobile health (mHealth) support delivered via the LINE application, including educational messages and motivational content to reinforce self-management behaviors. The intervention is delivered over a 12-week period to support recovery after hospital discharge and promote sustained healthy behaviors.
Receives: Behavioral: Innovative Care Approach
Arm 2: Control Group - Usual CareActive comparatorParticipants randomized to the control group will receive usual post-acute coronary syndrome (ACS) care. Usual care includes regularly scheduled follow-up visits with cardiologists at approximately 12-week intervals, medication review and adjustment as clinically indicated, and standard brief verbal education on secondary prevention behaviors, including heart-healthy diet, safe physical activity, and adherence to prescribed medication regimens provided by cardiologists and nursing staff. Participants in this group will also receive printed educational materials provided by the researcher. No additional mobile health support or structured motivational intervention will be provided.
Receives: Other: Usual Post-Acute Coronary Syndrome Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healthy behaviors

    Healthy behaviors refer to adhering to recommended healthy lifestyle changes, mainly in diet, physical activity, medication adherence, and other relevant self-care behaviors, including avoiding smoking or second-hand smoke, air pollution, managing stress, and avoiding getting sick, especially flu infections. The Thai version of the Self-Care of Coronary Heart Disease Inventory Version 3 (SC-CHDI-V3) will be applied to measure healthy behaviors. The standardized score ranges from 0 to 100; the cut-off point scores lower than 70 indicate inadequate self-care maintenance behaviors (poor healthy behaviors); in contrast, a score of 70 or higher indicates good self-care maintenance behaviors (good healthy behaviors).

    Measured: Baseline, 8 weeks, and 12 weeks

  2. Health status

    Health status refers to treatment outcomes perceived by older participants, including symptom burden, functional status, and quality of life. Symptom burden refers to the frequency, severity, and impact of symptoms related to ACS, such as chest pain, chest tightness, or angina, while functional status is the patient's ability to perform daily activities and maintain independence, such as walking, housekeeping, and other activities. It reflects how well the patient is able to perform day-to-day activities. Quality of life indicates the overall perception of satisfaction in their life. The health status will be measured using the Seattle Angina Questionnaire (SAQ-7). The SAQ-7 score ranges from 0 - 100, with higher scores indicating less angina, fewer functional limitations, and better quality of life.

    Measured: Baseline, 8 weeks, and 12 weeks

  3. Patient satisfaction

    Patient satisfaction is the patients' level of satisfaction with the care they received, including their experiences with the innovative care approach and mHealth technology, as well as their interactions with healthcare providers. It will be measured by the Patient Satisfaction with Nurse Care Questionnaire (PSNCQ). The PSNCQ score ranges from 15 to 75; a low score indicates a lower level of satisfaction, while a higher score indicates greater satisfaction.

    Measured: Baseline, 12 weeks (Intervention group only)

Secondary outcomes (1)
  1. Unplanned hospital visit

    Unplanned hospital visit refers to a situation in which an older person post-ACS needs medical care at a hospital without a prior appointment or scheduled visit, including urgent care at the emergency departments or hospital admissions. The number of unplanned emergency department visits or unplanned hospital admissions within the 12-week study period will be recorded. Data will be collected from the electronic hospital records (EHR).

    Measured: Cumulative count up to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start10 Mar 2026 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion10 Jan 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study uses a parallel-group, superiority randomized controlled trial model with two arms. Eligible participants are randomly assigned in a 1:1 ratio to either an intervention group receiving an innovative nurse-led care approach or a control group receiving usual post-acute coronary syndrome (ACS) care. Randomization occurs at the individual participant level after completion of baseline assessment. Outcomes are measured repeatedly over time to compare changes between groups during a 12-week follow-up period. The quantitative trial is complemented by a post-intervention qualitative component conducted among a subset of participants in the intervention group to further explore participant experiences.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07390006
Sponsor's protocol ID
MURA2026/42
Other IDs
COA. No. MURA2026/42
Status last verified
Feb 2026
First submitted
29 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Study findings will be reported in aggregate form only, in accordance with institutional review board approval and participant consent.

Publications

  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

    PubMed 21513547
  • Moons P, Norekval TM, Arbelo E, Borregaard B, Casadei B, Cosyns B, Cowie MR, Fitzsimons D, Fraser AG, Jaarsma T, Kirchhof P, Mauri J, Mindham R, Sanders J, Schiele F, Torbica A, Zwisler AD. Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management. Eur Heart J. 2023 Sep 21;44(36):3405-3422. doi: 10.1093/eurheartj/ehad514.

    PubMed 37606064
  • Cruz-Cobo C, Bernal-Jimenez MA, Vazquez-Garcia R, Santi-Cano MJ. Effectiveness of mHealth Interventions in the Control of Lifestyle and Cardiovascular Risk Factors in Patients After a Coronary Event: Systematic Review and Meta-analysis. JMIR Mhealth Uhealth. 2022 Dec 2;10(12):e39593. doi: 10.2196/39593.

    PubMed 36459396
  • Zhu Y, Zhao Y, Wu Y. Effectiveness of mobile health applications on clinical outcomes and health behaviors in patients with coronary heart disease: A systematic review and meta-analysis. Int J Nurs Sci. 2024 Mar 10;11(2):258-275. doi: 10.1016/j.ijnss.2024.03.012. eCollection 2024 Apr.

    PubMed 38707688
  • Damluji AA, Forman DE, Wang TY, Chikwe J, Kunadian V, Rich MW, Young BA, Page RL 2nd, DeVon HA, Alexander KP; American Heart Association Cardiovascular Disease in Older Populations Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; and Council on Lifestyle and Cardiometabolic Health. Management of Acute Coronary Syndrome in the Older Adult Population: A Scientific Statement From the American Heart Association. Circulation. 2023 Jan 17;147(3):e32-e62. doi: 10.1161/CIR.0000000000001112. Epub 2022 Dec 12.

    PubMed 36503287
  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

    PubMed 37622654

Questions about this trial

What is this clinical trial studying?

A study testing Innovative Care Approach and Usual Post-Acute Coronary Syndrome Care in people with Acute Coronary Syndrome/ Myocardial Infarction and Coronary Artery Disease, run by Mahidol University at 1 site in Thailand.

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 9 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Feb 2026. 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 Thailand. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jamchan Prateepmanowong, PhD (+666 3514 2445, Jamchan.pra@student.mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healthy behaviors (time frame: Baseline, 8 weeks, and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07390006, which also lists 6 linked publications.

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 9 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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