Nursing Intervention for Adaptation After Myocardial Revascularization

NCT07576569 | Not Yet Recruiting

• 1 other identifier: ENFPHD-16-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Myocardial revascularization is an essential procedure for patients with cardiovascular disease. Its recovery in the outpatient setting involves significant challenges for both the patient and the caregiver. This recovery phase may generate physical, emotional, and psychological complications that require an effective adaptation process of the patient-caregiver dyad to ensure successful recovery and improved quality of life. Objective: To evaluate the preliminary effectiveness of a nursing intervention aimed at improving adaptation in the patient-caregiver dyad during the outpatient postoperative period following myocardial revascularization, compared with usual care, in Bucaramanga during the period 2026-2027. Materials and Methods: A pilot randomized controlled trial will be conducted to develop and evaluate a novel nursing intervention aimed at promoting adaptation in patients undergoing outpatient postoperative myocardial revascularization and their caregivers. The intervention will be designed and its feasibility, acceptability, and preliminary effectiveness will be assessed. Data analysis will be performed using descriptive and inferential statistical methods, considering the distribution and behavior of the data. Expected Results: The study is expected to assess the preliminary effectiveness of the proposed intervention through the integration of theoretical and empirical components.

Conditions

Coronary Artery Disease; Myocardial Revascularization; Postoperative Recovery After Cardiac Surgery; Nursing Care

Keywords

Myocardial Revascularization; Nursing Intervention; Patient-Caregiver Dyad; Adaptation; Postoperative Recovery; Cardiovascular Disease; Randomized Controlled Trial; Outpatient Care

Outcome Measures

Primary Outcomes (1)

• Adaptation level in the patient-caregiver dyad

  Adaptation will be assessed using validated instruments that measure dimensions related to the Roy Adaptation Model, including physiological, self-concept, role function, and interdependence domains in both patient and caregiver.

  Baseline and 30 days post-discharge

Study Arms (2)

Nursing Intervention

EXPERIMENTAL

Participants will receive a structured nursing intervention based on the Roy Adaptation Model, including education, emotional support, and follow-up during the 30-day outpatient postoperative period following myocardial revascularization.

Behavioral: Nursing Intervention Program

Usual Care

ACTIVE COMPARATOR

Participants will receive standard postoperative care without the structured nursing intervention.

Other: Usual Care

Interventions

Nursing Intervention Program BEHAVIORAL

Structured nursing intervention focused on improving adaptation in the patient-caregiver dyad through education, emotional support, and follow-up care.

Nursing Intervention

Usual Care OTHER

Participants will receive standard postoperative care without the structured nursing intervention.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older who have undergone myocardial revascularization surgery, completed the immediate postoperative in-hospital period without major complications, and have been discharged for outpatient management according to institutional protocols
• Patients who, at the time of discharge, do not require ventilatory support, invasive hemodynamic support, or continuous monitoring, and present documented clinical stability
• Presence of an identified primary caregiver actively involved in the home care process during the outpatient postoperative period
• Preserved cognitive capacity in both patient and caregiver, allowing understanding of instructions, participation in the intervention, and completion of assessment instruments
• Written informed consent provided by both patient and caregiver

You may not qualify if:

• Patients presenting severe postoperative complications, such as deep surgical site infection, persistent hemodynamic instability, major neurological events, or readmission to the intensive care unit at the start of the intervention Patients with moderate to severe cognitive impairment, decompensated psychiatric disorders, or neurological conditions that limit understanding, communication, or active participation
• Caregivers with physical, cognitive, or emotional limitations that compromise the effective performance of the caregiving role during the follow-up period
• Patients without a clearly identified support network or without an available primary caregiver to participate in the study
• Concurrent participation in other clinical, educational, or psychosocial intervention studies that may interfere with the proposed intervention
• Language or cultural barriers that prevent understanding of the intervention content or interaction with the research team, without adequate mediation

Sponsors & Collaborators

• Universidad de la Sabana: lead

Study Sites (1)

Universidad de La Sabana

Bogotá, Bogota D.C., 250001, Colombia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Alvarez Yañez

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Débora Milena Alvarez Yañez, PhD(c)

CONTACT

+57 3112323289; deboraalya@unisabana.edu.co

Gloria Carvajal Carrascal, PhD

CONTACT

+57 3115062590; gloria.carvajal@unisabana.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants (patients and caregivers) will be blinded to group allocation and will not be informed whether they are receiving the structured nursing intervention or usual care. Outcome assessors will also be blinded to group assignment to reduce assessment bias. Due to the nature of the intervention, care providers and investigators cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel groups: an experimental group receiving a structured nursing intervention and a control group receiving usual care. The intervention will be delivered over a 30-day outpatient postoperative period following myocardial revascularization. Outcomes will be assessed at baseline and after the intervention period to compare effectiveness between groups.

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)