Acute Coronary Syndrome/ Myocardial Infarction, Coronary Artery Disease
Conditions
Keywords
Acute Coronary Syndrome, Mobile Health, Nurse-led Counseling, Patient Reported Outcome, Older Adult
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.
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.
Interventions
BEHAVIORALInnovative 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.
OTHERUsual Post-Acute Coronary Syndrome Care
Standard post-acute coronary syndrome care provided according to routine clinical practice.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthy behaviors | 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). |
| Health status | 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. |
| Patient satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned hospital visit | 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). |
Countries
Thailand
Contacts
CONTACTJamchan Prateepmanowong, PhD
CONTACTSuparb Aree-Ue, PhD
PRINCIPAL_INVESTIGATORJamchan Prateepmanowong, PhD
Mahidol University
Outcome results
None listed