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Nursing Intervention for Adaptation After Myocardial Revascularization (ADAPT-CABG)

2. mai 2026 oppdatert av: Universidad de la Sabana

Preliminary Effectiveness of a Nursing Intervention Aimed at Improving Adaptation in Patients and Their Caregivers During the Outpatient Postoperative Period Following Myocardial Revascularization

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 250001
        • Universidad de La Sabana

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Nursing Intervention
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.
Structured nursing intervention focused on improving adaptation in the patient-caregiver dyad through education, emotional support, and follow-up care.
Aktiv komparator: Usual Care
Participants will receive standard postoperative care without the structured nursing intervention.
Participants will receive standard postoperative care without the structured nursing intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adaptation level in the patient-caregiver dyad
Tidsramme: Baseline and 30 days post-discharge
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Alvarez Yañez, Universidad de La Sabana

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

2. mai 2026

Først innsendt som oppfylte QC-kriteriene

2. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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