Efficacy of a Technology-Enhanced Continuous Nursing Intervention on Clinical Outcomes and Quality of Life Following Coronary Artery Bypass Grafting: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin (Hb) Level
研究概览
简要总结
This is a prospective, randomized controlled trial to evaluate the effectiveness of a Technology-Enhanced Continuous Nursing System (TECNS) compared to routine care for patients after coronary artery bypass grafting (CABG). The study aims to determine if the TECNS intervention, which includes digital health tools, personalized tele-rehabilitation, and continuous nursing support, can improve clinical outcomes such as postoperative hemoglobin recovery, reduce long-term major adverse cardiac events (MACE), and enhance patients' quality of life and psychological well-being.
详细描述
Patients undergoing coronary artery bypass grafting (CABG) face significant challenges during the post-discharge recovery period. The transition from hospital to home often creates a "care gap," where insufficient support and follow-up can lead to suboptimal outcomes, including poor medication adherence, increased complication rates, and diminished quality of life. This study was designed to address this gap by implementing and evaluating a Technology-Enhanced Continuous Nursing System (TECNS). Participants were randomized to receive either the comprehensive TECNS intervention for 6 months post-discharge or standard routine care. The TECNS intervention integrated a dedicated smartphone application for education, a WeChat group for peer and professional support, personalized tele-rehabilitation plans delivered by nurses, and coordination with community health centers. The study hypothesized that this proactive, continuous care model would lead to superior physiological recovery, better long-term clinical outcomes, and improved patient-reported outcomes compared to the traditional, fragmented approach to post-discharge care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Meeting diagnostic criteria for elective CABG
- •Able to provide informed consent
- •Owned a smartphone and was willing to use it for the study intervention
排除标准
- •Emergency or salvage CABG
- •Severe coexisting conditions that could confound outcomes (e.g., end-stage renal disease, severe COPD [GOLD stage IV], active malignancy)
- •Left ventricular ejection fraction < 30%
- •Participation in other clinical trials
- •Severe cognitive impairment or psychiatric disorders precluding informed consent or adherence to the protocol
研究组 & 干预措施
Experimental: Technology-Enhanced Continuous Nursing System (TECNS) Group
Patients received a comprehensive, 6-month continuous nursing program post-discharge. This included training on a dedicated smartphone app for educational modules; access to a moderated WeChat group for peer support and health tips; scheduled tele-rehabilitation calls from cardiac nurses for monitoring, education, and personalized guidance; and coordination with community health centers for follow-up. This was in addition to standard in-hospital care.
干预措施: Technology-Enhanced Continuous Nursing System (Behavioral)
Active Comparator: Routine Care Group
Patients received standard institutional postoperative care, including basic discharge education (oral and written summaries on medication, diet, and activity). Post-discharge care consisted of scheduled outpatient follow-up visits at 1 and 3 months post-surgery, without the technology-enhanced continuous support components.
干预措施: Routine Postoperative Care (Behavioral)
结局指标
主要结局
Change in Hemoglobin (Hb) Level
时间窗: Baseline, Day 7
Change in blood hemoglobin concentration from baseline to 7 days after surgery, measured by laboratory analysis. This assesses the rate of postoperative hematopoietic recovery.
Major Adverse Cardiac Events (MACE)-Free Survival
时间窗: Up to 24 months
The rate of survival free from MACE, defined as a composite of cardiovascular death, non-fatal myocardial infarction, stroke, or unplanned revascularization.
次要结局
- Patient Satisfaction(1 month)
- Change in Anxiety Symptoms(Baseline, 1 month, 3 months, 6 months)
- Change in Red Blood Cell Indices(Baseline, Day 7)
- Change in Quality of Life (QoL)(Baseline, 1 month, 3 months, 6 months)
- Change in Interleukin-2 (IL-2) Level(Baseline, Day 7)
- Change in Interleukin-6 (IL-6) Level(Baseline, Day 7)
- Change in high-sensitivity C-reactive protein (hs-CRP) Level(Baseline, Day 7)
- Change in Depression Symptoms(Baseline, 1 month, 3 months, 6 months)
研究者
Beibei Xing
Principal investigator
The First Hospital of Hebei Medical University