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Coronary Artery DiseaseNCT07117331

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

A study testing Technology-Enhanced Continuous Nursing System and Routine Postoperative Care in people with Coronary Artery Disease, run by The First Hospital of Hebei Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Technology-Enhanced Continuous Nursing System and Routine Postoperative Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
1 siteChina
Study dates
1 Jan 2018to 30 Jun 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

Other trials in China

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Technology-Enhanced Continuous Nursing System, Routine Postoperative Care
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technology-Enhanced Continuous Nursing SystemBehavioural

    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 CareBehavioural

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

Study groups in NCT07117331
Study groupRoleWhat they receive
Experimental: Technology-Enhanced Continuous Nursing System (TECNS) GroupExperimentalPatients 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.
Receives: Behavioral: Technology-Enhanced Continuous Nursing System
Active Comparator: Routine Care GroupActive comparatorPatients 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.
Receives: Behavioral: Routine Postoperative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Day 7

  2. 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.

    Measured: Up to 24 months

Secondary outcomes (8)

  1. Change in Red Blood Cell Indices

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

    Measured: Baseline, Day 7

  2. Change in Quality of Life (QoL)

    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.

    Measured: Baseline, 1 month, 3 months, 6 months

  3. Patient Satisfaction

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

    Measured: 1 month

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

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

    Measured: Baseline, Day 7

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

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

    Measured: Baseline, Day 7

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

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

    Measured: Baseline, Day 7

  7. Change in Anxiety Symptoms

    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).

    Measured: Baseline, 1 month, 3 months, 6 months

  8. Change in Depression Symptoms

    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).

    Measured: Baseline, 1 month, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start1 Jan 2018
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117331
Sponsor's protocol ID
2017S00298
Status last verified
Jul 2025
First submitted
30 Jul 2025
Last updated
12 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Technology-Enhanced Continuous Nursing System and Routine Postoperative Care in people with Coronary Artery Disease, 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 5 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 12 Aug 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) Level (time frame: Baseline, Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07117331.

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 12 Aug 2025.

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