NCT07062432

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

July 2, 2025

Last Update Submit

July 10, 2025

Conditions

Keywords

Continuous comprehensive nursing systemCoronary artery bypass surgeryHemoglobin levelsQuality of lifeNursing Efficacy

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin (Hb) Levels from Baseline to 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 Outcomes (7)

  • Change in Hemoglobin (Hb) Levels at Other Time Points

    Baseline, 12 hours, 72 hours, and 14 days post-surgery.

  • Red Blood Cell Indices

    Day 7 post-surgery.

  • Levels of Immune-Related Inflammatory Markers

    Day 7 post-surgery.

  • Quality of Life (QoL)

    Day 14 post-surgery.

  • Depressive Symptoms

    Day 14 post-surgery.

  • +2 more secondary outcomes

Study Arms (2)

Continuous Comprehensive Nursing (CCN) System

EXPERIMENTAL

Participants received a continuous comprehensive care plan delivered by specifically trained cardiac nurses. This plan included: * Preoperative Phase: Comprehensive education about the surgery, risks, and expected outcomes, along with psychological support. * Intraoperative Phase: Standard intraoperative nursing care including close monitoring. * Postoperative Inpatient Phase: In addition to routine care, this phase focused on pain management, wound care, and individualized rehabilitation guidance. * Post-Discharge Continuous Phase (3 months): This phase included regular follow-up (monthly phone calls, one outpatient visit at 6 weeks), ongoing psychological support, continuous education (medication adherence, diet, activity), structured home-based rehabilitation training, and periodic evaluation of quality of life.

Behavioral: Continuous Comprehensive Nursing System

Routine Care

ACTIVE COMPARATOR

Participants received standard institutional postoperative care for CABG, which primarily focused on the inpatient period. Key elements included: * Monitoring of vital signs, consciousness, and peripheral circulation. * Management of respiratory tract patency and urinary catheters. * Hourly monitoring of drainage tubes initially. * Wound care and monitoring for bleeding. * Body temperature monitoring and oral care. * Guidance on progressing from liquid diets. * Standard discharge instructions without structured post-discharge follow-up.

Other: Routine Postoperative Care

Interventions

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.

Continuous Comprehensive Nursing (CCN) System

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.

Routine Care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 14, 2025

Study Start

February 1, 2020

Primary Completion

March 31, 2022

Study Completion

June 30, 2022

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations