Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTechnology-Enhanced Continuous Nursing System
A multi-faceted behavioral and educational intervention lasting 6 months post-discharge. It utilized a smartphone app, WeChat, tele-monitoring (phone/video calls), and community health partnerships to provide structured education, personalized rehabilitation plans, and continuous professional nursing support.
BEHAVIORALRoutine Postoperative Care
Standard institutional care including standard discharge instructions and routine outpatient follow-up appointments.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin (Hb) Level | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QoL) | Baseline, 1 month, 3 months, 6 months | Change in patient-reported quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) scale. The scale ranges from 0 to 100. Higher scores indicate better QoL. |
| Patient Satisfaction | 1 month | Patient-reported satisfaction with nursing care, assessed using a study-specific questionnaire. Responses are categorized ('Very Satisfied', 'Satisfied', 'Average', 'Dissatisfied'). |
| Change in Interleukin-2 (IL-2) Level | Baseline, Day 7 | Change in serum level of Interleukin-2 (IL-2) from baseline, measured by laboratory analysis. |
| Change in Interleukin-6 (IL-6) Level | Baseline, Day 7 | Change in serum level of Interleukin-6 (IL-6) from baseline, measured by laboratory analysis. |
| Change in Anxiety Symptoms | Baseline, 1 month, 3 months, 6 months | Change in symptoms of anxiety assessed using the Self-Rating Anxiety Scale (SAS). The scale range is 25-100. Lower scores indicate better mental health (less anxiety). |
| Change in Depression Symptoms | Baseline, 1 month, 3 months, 6 months | Change in symptoms of depression assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The scale range is 0-60. Lower scores indicate better mental health (less depression). |
| Change in high-sensitivity C-reactive protein (hs-CRP) Level | Baseline, Day 7 | Change in serum level of high-sensitivity C-reactive protein (hs-CRP) from baseline, measured by laboratory analysis. |
| Change in Red Blood Cell Indices | Baseline, Day 7 | Change in Mean Corpuscular Volume (MCV), Red Blood Cell Distribution Width (RDW), and Hematocrit (HCT) from baseline. |
Countries
China
Outcome results
None listed