NCT07117331

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
358

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable coronary-artery-disease

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
Last Updated

August 12, 2025

Status Verified

July 1, 2025

Enrollment Period

7.5 years

First QC Date

July 30, 2025

Last Update Submit

August 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Hemoglobin (Hb) Level

    Change in blood hemoglobin concentration from baseline to 7 days after surgery, measured by laboratory analysis. This assesses the rate of postoperative hematopoietic recovery.

    Baseline, Day 7

  • Major Adverse Cardiac Events (MACE)-Free Survival

    The rate of survival free from MACE, defined as a composite of cardiovascular death, non-fatal myocardial infarction, stroke, or unplanned revascularization.

    Up to 24 months

Secondary Outcomes (8)

  • Change in Red Blood Cell Indices

    Baseline, Day 7

  • Change in Quality of Life (QoL)

    Baseline, 1 month, 3 months, 6 months

  • Patient Satisfaction

    1 month

  • Change in Interleukin-2 (IL-2) Level

    Baseline, Day 7

  • Change in Interleukin-6 (IL-6) Level

    Baseline, Day 7

  • +3 more secondary outcomes

Study Arms (2)

Experimental: Technology-Enhanced Continuous Nursing System (TECNS) Group

EXPERIMENTAL

Patients received a comprehensive, 6-month continuous nursing program post-discharge. This included training on a dedicated smartphone app for educational modules; access to a moderated WeChat group for peer support and health tips; scheduled tele-rehabilitation calls from cardiac nurses for monitoring, education, and personalized guidance; and coordination with community health centers for follow-up. This was in addition to standard in-hospital care.

Behavioral: Technology-Enhanced Continuous Nursing System

Active Comparator: Routine Care Group

ACTIVE COMPARATOR

Patients received standard institutional postoperative care, including basic discharge education (oral and written summaries on medication, diet, and activity). Post-discharge care consisted of scheduled outpatient follow-up visits at 1 and 3 months post-surgery, without the technology-enhanced continuous support components.

Behavioral: Routine Postoperative Care

Interventions

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.

Experimental: Technology-Enhanced Continuous Nursing System (TECNS) Group

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

Active Comparator: Routine Care Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 12, 2025

Study Start

January 1, 2018

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 12, 2025

Record last verified: 2025-07

Locations