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

Mahidol University

Status: Begins enrollment this month

Conditions: Coronary Artery Disease; Acute Coronary Syndrome/ Myocardial Infarction

Treatments: Other: Usual Post-Acute Coronary Syndrome Care; Behavioral: Innovative Care Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT07390006

MURA2026/42

COA. No. MURA2026/42 (Other Identifier)

Details and patient eligibility

About

This study evaluates the effectiveness of an innovative nurse-led 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.

Full description

This is a single-site, mixed-methods experimental study designed to evaluate the effectiveness of an innovative nurse-led 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion Criteria for the quantitative phase:

1. Aged ≥ 60 years old.
2. Diagnosed with ACS and received PCI within 3-12 months.
3. Being familiar with using a smartphone or tablet with the Line application, either personally or through a caregiver or family member.
4. No cognitive impairment assessed by the 6-Item Cognitive Function Test-Thai Version (6CIT) (Aree-Ue & Youngcharoen, 2020), score less than 8.
5. Able to communicate in the Thai language by speaking, listening, reading, and writing in Thai sufficiently.
6. Voluntarily agreed to participate and has signed the informed consent form.

Inclusion Criteria for the qualitative phase:

1. Participate in the experimental group and complete the program.
2. Extreme case sampling involves selecting the top 6 highest and top 6 lowest scores for healthy behavior.
3. Willing to participate in a one-on-one in-depth interview.

Exclusion criteria

Exclusion Criteria for the quantitative phase:

1. 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.
2. 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Arm 1: Intervention Group - Innovative Care Approach

Experimental group

Description:

Participants 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.

Treatment:

Behavioral: Innovative Care Approach

Arm 2: Control Group - Usual Care

Active Comparator group

Description:

Participants 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.

Treatment:

Other: Usual Post-Acute Coronary Syndrome Care