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临床试验/NCT07392021
NCT07392021进行中(未招募)不适用

The Effects of a Recovery-Promoting Program on Self-Efficacy, Quality of Recovery, and Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Graft Surgery

Mahidol University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月22日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Quality of Recovery after CABG.

研究概览

简要总结

Patients undergoing coronary artery bypass graft (CABG) surgery often experience physical limitations, psychological stress, and challenges during recovery after hospital discharge. Inadequate preparation and limited follow-up support may affect patients' confidence in self-care and overall recovery.

The purpose of this study is to evaluate the effects of a recovery-promoting program on self-efficacy, quality of recovery, and clinical outcomes in patients undergoing CABG surgery.

Participants will receive standard postoperative care. In addition, participants in the intervention group will receive a recovery-promoting program provided by nurses, which includes structured education, guidance on postoperative activity and symptom management, and follow-up support after discharge.

The study will assess changes in self-efficacy, quality of recovery, and selected clinical outcomes to compare recovery between participants who receive the recovery-promoting program and those who receive standard care.

详细描述

Coronary artery bypass graft (CABG) surgery is a standard treatment for patients with advanced coronary artery disease. Although surgical outcomes have improved, patients frequently experience challenges during postoperative recovery, including reduced physical capacity, delayed functional recovery, psychological distress, and difficulties in self-management after hospital discharge. These challenges may contribute to prolonged recovery and suboptimal clinical outcomes.

Evidence-based approaches such as Cardiac Rehabilitation (CR) and Enhanced Recovery After Cardiac Surgery (ERAS) have been shown to support postoperative recovery. However, in routine clinical practice, the application of these approaches is often fragmented, and continuity of care after discharge remains limited. In particular, patients may receive insufficient guidance and support to enhance self-efficacy and confidence in managing recovery at home.

This study aims to evaluate the effects of a recovery-promoting program on self-efficacy, quality of recovery, and clinical outcomes in patients undergoing CABG surgery. The recovery-promoting program integrates key components of CR and ERAS principles and is delivered by nurses using a structured approach. The intervention includes pre-discharge education, guidance on postoperative activity and symptom management, and follow-up support after discharge through a tele-nursing platform. This approach is designed to enhance patients' engagement in recovery and support continuity of care beyond hospital discharge.

A quasi-experimental design is used to compare outcomes between patients receiving standard postoperative care and those receiving the recovery-promoting program in addition to standard care. Eligible patients are assigned to either a control group or an experimental group according to the study protocol. Data are collected at predefined time points to evaluate changes in self-efficacy, quality of recovery, and selected clinical outcomes.

Self-efficacy and quality of recovery are assessed using validated instruments, while clinical outcomes are obtained from clinical records and routine assessments. The primary focus of the study is to examine differences between groups over time and to explore the potential role of a structured, nurse-led recovery-promoting program in supporting postoperative recovery following CABG surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

This is an open-label study. No masking is applied to participants, care providers, investigators, or outcome assessors.

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Thai patients undergoing elective first-time on-pump coronary artery bypass graft (CABG) surgery alone or combined with valve surgery
  • If age >60 years, participants must pass cognitive screening using the 6-Item Cognitive Impairment Test (6-CIT)
  • New York Heart Association (NYHA) functional class I-III
  • Left ventricular ejection fraction (LVEF) >30%
  • Independent in activities of daily living and able to perform the 6-minute walk test (6MWT)

排除标准

  • Severe or acute comorbidities within 24 hours prior to surgery (e.g., chronic obstructive pulmonary disease, renal failure, acute myocardial infarction, severe arrhythmia)
  • Severe postoperative complications or unstable vital signs (e.g., major bleeding, significant arrhythmia, embolism, need for dialysis, extracorporeal membrane oxygenation)
  • Disability or limited ambulation or mobility assessed prior to hospital discharge
  • Failure of extubation within 3 days after surgery or requirement for reoperation

研究组 & 干预措施

Recovery Promotion Program for CABG patients

Experimental

Participants in this arm receive an integrated recovery promotion program combining Cardiac Rehabilitation (CR) and Enhanced Recovery After Cardiac Surgery (ERAS) in addition to standard postoperative care. The program includes structured education, early mobilization, breathing exercises, symptom monitoring, and self-management support delivered by nurses through in-hospital sessions and a LINE Official Account after discharge. The intervention aims to enhance self-efficacy, promote functional recovery, and reduce postoperative complications following coronary artery bypass grafting (CABG).

干预措施: Recovery Promotion Program for CABG patients (Behavioral)

Standard CABG Care

Active Comparator

Participants in this arm receive standard postoperative care according to hospital protocols for patients undergoing coronary artery bypass grafting (CABG). This includes routine medical and nursing care, usual postoperative monitoring, discharge education, and follow-up appointments without the structured integrated Cardiac Rehabilitation and ERAS program or LINE-based support.

干预措施: Standard Postoperative CABG Care (Other)

结局指标

主要结局

Quality of Recovery after CABG.

时间窗: up to 8 weeks after surgery

Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated postoperative recovery instrument consisting of 15 items with a total score ranging from 0 to 150. The questionnaire assesses physical comfort, emotional state, psychological support, and physical independence. Higher scores indicate better postoperative recovery.

次要结局

  • Self Efficacy(Preoperative, baseline; within 2 weeks prior to surgery and immediately prior to surgery)
  • Functional capacity(up to 8 weeks after surgery.)
  • Pulmonary Function(Baseline (preoperative, at initial patient assessment); perioperative period (at hospital admission); at hospital discharge (postoperative day 7).)
  • Duration of mechanical ventilation(Perioperative period.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thanyaphat Chaisunthararat

Registered Nurse and Graduate Student (Master of Nursing Science)

Mahidol University

研究点 (1)

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