Coronary Heart Disease (CHD)NCT07062432
Continuous Comprehensive Nursing for Post-CABG Recovery
A study testing Continuous Comprehensive Nursing System and Routine Postoperative Care in people with Coronary Heart Disease (CHD), run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- Continuous Comprehensive Nursing System and Routine Postoperative Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease (CHD)
- Being tested
- Continuous Comprehensive Nursing System, Routine Postoperative Care
- Keywords
- Continuous comprehensive nursing system, Coronary artery bypass surgery, Hemoglobin levels, Quality of life, Nursing Efficacy
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Comprehensive Nursing SystemBehavioural
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.
Routine Postoperative CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperatively) and Day 7 post-surgery.
Secondary outcomes (7)
Change in Hemoglobin (Hb) Levels at Other Time Points
Hemoglobin concentration (g/L) measured at multiple time points to assess the recovery trajectory.
Measured: Baseline, 12 hours, 72 hours, and 14 days post-surgery.
Red Blood Cell Indices
Measurement of Mean Corpuscular Volume (MCV, in fL), Red Blood Cell Distribution Width (RDW, in %), and Hematocrit (HCT, in %).
Measured: Day 7 post-surgery.
Levels of Immune-Related Inflammatory Markers
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.
Measured: Day 7 post-surgery.
Quality of Life (QoL)
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.
Measured: Day 14 post-surgery.
Depressive Symptoms
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.
Measured: Day 14 post-surgery.
Anxiety Symptoms
Assessed using the Self-Rating Anxiety Scale (SAS). The scale ranges from 20 to 80, with higher scores reflecting more severe anxiety symptoms.
Measured: Day 14 post-surgery.
Patient Satisfaction
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.
Measured: Up to 14 days post-surgery (at time of hospital discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Feb 2020
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beibei Xing, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062432
- Sponsor's protocol ID
- 2019-HBLS-ky038
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a Continuous Comprehensive Nursing System on Postoperative Hemoglobin Levels and Quality of Life in Patients Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT07062432
- Acronym / sponsor ID
- 2019-HBLS-ky038
- Conditions
- Coronary Heart Disease (CHD)
- Keywords
- Continuous comprehensive nursing system, Coronary artery bypass surgery, Hemoglobin levels, Quality of life, Nursing Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Comprehensive Nursing (CCN) System | Experimental | Behavioral: Continuous Comprehensive Nursing SystemParticipants 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. |
| Routine Care | Active comparator | Other: Routine Postoperative CareParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Comprehensive Nursing SystemA 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. | Behavioural | Continuous Comprehensive Nursing (CCN) System |
| Routine Postoperative CareStandard 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. | Other | Routine Care |
Primary outcome
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.
7 secondary outcomes
Change in Hemoglobin (Hb) Levels at Other Time Points
Time frame: Baseline, 12 hours, 72 hours, and 14 days post-surgery.
Red Blood Cell Indices
Time frame: Day 7 post-surgery.
Levels of Immune-Related Inflammatory Markers
Time frame: Day 7 post-surgery.
Quality of Life (QoL)
Time frame: Day 14 post-surgery.
Depressive Symptoms
Time frame: Day 14 post-surgery.
Anxiety Symptoms
Time frame: Day 14 post-surgery.
Patient Satisfaction
Time frame: Up to 14 days post-surgery (at time of hospital discharge).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Comprehensive Nursing System and Routine Postoperative Care in people with Coronary Heart Disease (CHD), run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin (Hb) Levels from Baseline to Day 7 Post-Surgery (time frame: Baseline (preoperatively) and Day 7 post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.