- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07062432
- Original Trial
Continuous Comprehensive Nursing for Post-CABG Recovery
July 10, 2025 updated by: Beibei Xing, The First Hospital of Hebei Medical University
Evaluating the Efficacy of a Continuous Comprehensive Nursing System on Postoperative Hemoglobin Levels and Quality of Life in Patients Undergoing Coronary Artery Bypass Surgery
This study evaluates the effectiveness of a continuous comprehensive nursing (CCN) system compared to routine care for patients after coronary artery bypass graft (CABG) surgery.
The primary goal is to determine if the CCN system improves postoperative hemoglobin levels.
The study also investigates the effects on quality of life, mental health (anxiety and depression), red blood cell indices, immune markers, and patient satisfaction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Coronary artery bypass surgery (CABG) is a major procedure, and the postoperative recovery process is complex, often impacting patients' hemoglobin levels and quality of life.
Standard nursing care is often limited to the inpatient period.
A continuous comprehensive nursing (CCN) system is a holistic, patient-centered model that extends care beyond hospital discharge.
This model includes preoperative education, continuous monitoring, personalized care plans, psychological support, rehabilitation guidance, and structured follow-up.
While the benefits of comprehensive nursing are recognized, its specific impact on hemoglobin recovery and quality of life after CABG has not been extensively studied.
This randomized controlled trial was designed to compare the outcomes of patients receiving a CCN plan with those receiving routine postoperative care to provide evidence for optimizing post-CABG nursing strategies.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050000
- The First Hospital of Hebei Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18 and 70 years.
- Confirmed diagnosis of coronary heart disease and evidence of coronary artery illness requiring CABG.
- Ability to understand the purpose and procedures of the study.
- Willingness to sign the informed consent form.
Exclusion Criteria:
- Presence of serious complications such as unstable myocardial ischemia or significant arrhythmia.
- Severe lung diseases (e.g., chronic obstructive pulmonary disease GOLD stage III/IV).
- Severe kidney diseases (e.g., chronic kidney disease Stage 4/5).
- Significantly impaired left ventricular ejection fraction (EF < 30%).
- Concurrent participation in other clinical trials or receiving other interventions.
- Presence of severe mental illnesses or cognitive impairments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Continuous Comprehensive Nursing (CCN) System
Participants received a continuous comprehensive care plan delivered by specifically trained cardiac nurses. This plan included:
|
A multi-faceted nursing plan delivered by trained cardiac nurses, extending from the preoperative phase to 3 months post-discharge.
In addition to routine inpatient care, the intervention included: preoperative education and psychological support; postoperative individualized rehabilitation guidance; and a continuous post-discharge program.
The post-discharge phase involved structured follow-up (monthly phone calls, one 6-week outpatient visit), ongoing psychological support, reinforcement of education on medication adherence, diet, and activity progression, and guidance on a structured home-based exercise program.
|
|
Active Comparator: Routine Care
Participants received standard institutional postoperative care for CABG, which primarily focused on the inpatient period. Key elements included:
|
Standard institutional postoperative care for patients after Coronary Artery Bypass Graft (CABG) surgery.
This care was primarily focused on the inpatient period and included monitoring of vital signs, wound and drainage tube management, respiratory and circulatory support, and progressive diet guidance.
The care concluded with standard discharge instructions and did not include the structured, continuous, or extended follow-up provided to the intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Hemoglobin (Hb) Levels from Baseline to Day 7 Post-Surgery
Time Frame: Baseline (preoperatively) and Day 7 post-surgery.
|
The change in hemoglobin concentration (g/L) was measured from the preoperative baseline value to the value at 7 days after the surgery.
Venous blood samples were analyzed using an automatic biochemical analyzer.
|
Baseline (preoperatively) and Day 7 post-surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Hemoglobin (Hb) Levels at Other Time Points
Time Frame: Baseline, 12 hours, 72 hours, and 14 days post-surgery.
|
Hemoglobin concentration (g/L) measured at multiple time points to assess the recovery trajectory.
|
Baseline, 12 hours, 72 hours, and 14 days post-surgery.
|
|
Red Blood Cell Indices
Time Frame: Day 7 post-surgery.
|
Measurement of Mean Corpuscular Volume (MCV, in fL), Red Blood Cell Distribution Width (RDW, in %), and Hematocrit (HCT, in %).
|
Day 7 post-surgery.
|
|
Levels of Immune-Related Inflammatory Markers
Time Frame: Day 7 post-surgery.
|
Levels of Interleukin-2 (IL-2, in pg/mL) and Interleukin-6 (IL-6, in pg/mL) in peripheral blood, quantified using an ELISA kit.
|
Day 7 post-surgery.
|
|
Quality of Life (QoL)
Time Frame: Day 14 post-surgery.
|
Assessed using the World Health Organization Quality of Life BREF (WHOQOL-BREF) scale.
This scale evaluates four domains: physical health, psychological health, social relationships, and environment.
Higher scores indicate better quality of life.
|
Day 14 post-surgery.
|
|
Depressive Symptoms
Time Frame: Day 14 post-surgery.
|
Assessed using the Center for Epidemiologic Studies Depression Scale (CES-D).
The scale ranges from 0 to 60, with higher scores indicating more severe depressive symptoms.
|
Day 14 post-surgery.
|
|
Anxiety Symptoms
Time Frame: Day 14 post-surgery.
|
Assessed using the Self-Rating Anxiety Scale (SAS).
The scale ranges from 20 to 80, with higher scores reflecting more severe anxiety symptoms.
|
Day 14 post-surgery.
|
|
Patient Satisfaction
Time Frame: Up to 14 days post-surgery (at time of hospital discharge).
|
Assessed using a study-specific satisfaction questionnaire.
Responses were categorized as "very satisfied," "satisfied," "average," or "dissatisfied" based on a scoring system from 1-100.
|
Up to 14 days post-surgery (at time of hospital discharge).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
July 2, 2025
First Submitted That Met QC Criteria
July 10, 2025
First Posted (Actual)
July 14, 2025
Study Record Updates
Last Update Posted (Actual)
July 14, 2025
Last Update Submitted That Met QC Criteria
July 10, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-HBLS-ky038
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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