Enabling Patient-Reported Outcomes Through Innovative Care - ACS (EPIC-ACS)
2 other identifiers
interventional
80
1 country
1
Brief 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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedStudy Start
First participant enrolled
March 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 10, 2027
February 9, 2026
February 1, 2026
6 months
January 29, 2026
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
Baseline, 8 weeks, and 12 weeks
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.
Baseline, 8 weeks, and 12 weeks
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.
Baseline, 12 weeks (Intervention group only)
Secondary Outcomes (1)
Unplanned hospital visit
Cumulative count up to week 12
Other Outcomes (1)
Participant Experiences With the Innovative Care Approach
Weeks 13-16
Study Arms (2)
Arm 1: Intervention Group - Innovative Care Approach
EXPERIMENTALParticipants 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.
Arm 2: Control Group - Usual Care
ACTIVE 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.
Interventions
A nurse-led behavioral intervention including structured education, motivational counseling, and mobile health (mHealth) support delivered via the LINE application over 12 weeks.
Standard post-acute coronary syndrome care provided according to routine clinical practice.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Related Publications (6)
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.
PMID: 21513547BACKGROUNDMoons 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.
PMID: 37606064BACKGROUNDCruz-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.
PMID: 36459396BACKGROUNDZhu 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.
PMID: 38707688BACKGROUNDDamluji 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.
PMID: 36503287BACKGROUNDByrne 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.
PMID: 37622654BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamchan Prateepmanowong, PhD
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- This study will be a single-blind randomized controlled trial. The independent statistician, who will generate the randomization sequence, and outcome assessors will be blinded to group allocation to minimize assessment bias when collecting and analyzing patient-reported outcomes and hospital visit data.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2026
First Posted
February 5, 2026
Study Start
March 10, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
January 10, 2027
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.