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Completed

NCT Number: NCT07117331

Technology-Enhanced Continuous Nursing System (TECNS) for Post-CABG Recovery

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technology-Enhanced Continuous Nursing System

Behavioral

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.

Routine Postoperative Care

Behavioral

Standard institutional care including standard discharge instructions and routine outpatient follow-up appointments.

Primary outcomes

  1. Change in Hemoglobin (Hb) Level

    Time frame: 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.

  2. Major Adverse Cardiac Events (MACE)-Free Survival

    Time frame: 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 outcomes

  1. Change in Red Blood Cell Indices

    Time frame: Baseline, Day 7

    Change in Mean Corpuscular Volume (MCV), Red Blood Cell Distribution Width (RDW), and Hematocrit (HCT) from baseline.

  2. Change in Quality of Life (QoL)

    Time frame: 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.

  3. Patient Satisfaction

    Time frame: 1 month

    Patient-reported satisfaction with nursing care, assessed using a study-specific questionnaire. Responses are categorized ('Very Satisfied', 'Satisfied', 'Average', 'Dissatisfied').

  4. Change in Interleukin-2 (IL-2) Level

    Time frame: Baseline, Day 7

    Change in serum level of Interleukin-2 (IL-2) from baseline, measured by laboratory analysis.

  5. Change in Interleukin-6 (IL-6) Level

    Time frame: Baseline, Day 7

    Change in serum level of Interleukin-6 (IL-6) from baseline, measured by laboratory analysis.

  6. Change in high-sensitivity C-reactive protein (hs-CRP) Level

    Time frame: Baseline, Day 7

    Change in serum level of high-sensitivity C-reactive protein (hs-CRP) from baseline, measured by laboratory analysis.

  7. Change in Anxiety Symptoms

    Time frame: 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).

  8. Change in Depression Symptoms

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Efficacy of a Technology-Enhanced Continuous Nursing Intervention on Clinical Outcomes and Quality of Life Following Coronary Artery Bypass Grafting: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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