Enabling Patient-Reported Outcomes Through Innovative Care Approach in Thai Older Adults Post-Acute Coronary Syndrome: A Mixed Methods Experimental Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Healthy behaviors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for the quantitative phase:
- •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
- •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.
- •Inclusion Criteria for the qualitative phase:
- •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.
排除标准
- •Exclusion Criteria for the quantitative phase:
- •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.
研究组 & 干预措施
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.
干预措施: Innovative Care Approach (Behavioral)
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.
干预措施: Usual Post-Acute Coronary Syndrome Care (Other)
结局指标
主要结局
Healthy behaviors
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Unplanned hospital visit(Cumulative count up to week 12)