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

February 5, 2026 updated by: Mahidol University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jamchan Prateepmanowong, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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), 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Intervention Group - Innovative Care Approach
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.
Behavioral: Innovative Care Approach
A nurse-led behavioral intervention including structured education, motivational counseling, and mobile health (mHealth) support delivered via the LINE application over 12 weeks.
Active Comparator: Arm 2: Control Group - Usual Care
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.
Other: Usual Post-Acute Coronary Syndrome Care
Standard post-acute coronary syndrome care provided according to routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy behaviors
Time Frame: Baseline, 8 weeks, and 12 weeks
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).
Baseline, 8 weeks, and 12 weeks
Health status
Time Frame: Baseline, 8 weeks, and 12 weeks
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.
Baseline, 8 weeks, and 12 weeks
Patient satisfaction
Time Frame: Baseline, 12 weeks (Intervention group only)
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.
Baseline, 12 weeks (Intervention group only)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unplanned hospital visit
Time Frame: Cumulative count up to week 12
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).
Cumulative count up to week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Experiences With the Innovative Care Approach
Time Frame: Weeks 13-16
Participant experiences regarding perceived benefits, motivation, and engagement in adhering to the innovative care approach will be explored through semi-structured in-depth interviews. Qualitative data will be analyzed using thematic analysis to provide contextual understanding of the quantitative findings.
Weeks 13-16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Jamchan Prateepmanowong, PhD, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

January 10, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2026/42
  • COA. No. MURA2026/42 (Other Identifier: Ramathibodi IRB, Mahidol University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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