Individualized Nursing Care and Frailty Outcomes in Cardiac Surgery

NCT07471945 | Active Not Recruiting

• 1 other identifier: Decision Number: 33
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial aiming to compare targeted individualized nursing care with standard care in frail elderly patients undergoing cardiac surgery. The hypotheses of the study are: H1: Targeted individualized nursing care has an effect on the frailty level of frail elderly patients undergoing cardiac surgery. H2: Targeted individualized nursing care affects the factors influencing frailty in frail elderly patients undergoing cardiac surgery.

Conditions

Frail Patient; Cardiac Surgical Procedures (Postoperative Population); Patient-centered Care; Clinical Outcomes

Outcome Measures

Primary Outcomes (7)

• Cognitive Function - Standardized Mini-Mental State Examination (MMSE)

  Cognitive status will be assessed using the Standardized Mini-Mental State Examination (MMSE). The MMSE evaluates orientation, memory, attention, recall, language, and visuospatial skills. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores of 23 or below are generally considered indicative of cognitive impairment.

  Postoperative day 1 and the day of discharge

• Cognitive Function - Delirium Risk - Nursing Delirium Screening Scale (Nu-DESC)

  Delirium risk will be evaluated using the Nursing Delirium Screening Scale (Nu-DESC). The scale assesses five domains: disorientation, inappropriate behavior, inappropriate communication, hallucinations, and psychomotor retardation. Each symptom is scored per shift as follows: 0 points: Symptom absent, 1 point: Symptom present/mild, 2 points: Symptom present and pronounced/severe A total score of 2 points or higher is considered indicative of delirium.

  Postoperative day 1 and the day of discharge

• Physical Status Assessment - Pain Level - Numeric Rating Scale (NRS)

  Pain Level - Numeric Rating Scale (NRS): Pain intensity will be assessed using the Numeric Rating Scale (NRS). Patients rate their pain from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

  Postoperative day 1 and the day of discharge

• Physical Status Assessment - Katz Activities of Daily Living (ADL) Scale

  Katz Activities of Daily Living (ADL) Scale: Functional status will be evaluated using the Katz Activities of Daily Living (ADL) Scale, which assesses independence in six activities: bathing, dressing, toileting, transferring, continence, and feeding. Higher scores indicate greater independence in daily activities. Evaluation of the scale is based on the total score obtained from these items: 0-6 points: Dependent, 7-12 points: Partially dependent, 13-18 points: Independent.

  Postoperative day 1 and the day of discharge

• Physical Status Assessment - Itaki Fall Risk Scale

  Itaki Fall Risk Scale: The Itaki Fall Risk Scale will be used to evaluate patients' risk of falling. The scale assesses various risk factors related to falls in hospitalized patients. The scale consists of 19 risk factors that may contribute to patient falls. The risk factors are categorized as major and minor, with 1 point assigned for each minor risk factor and 5 points for each major risk factor. Based on the total score obtained from evaluating all risk factors, two risk levels are defined: 0-4 points: Low risk, 5 points and above: High risk.

  Postoperative day 1 and the day of discharge

• Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF)

  Mini Nutritional Assessment Short Form (MNA-SF): Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF). The total score ranges from 0 to 14, with higher scores indicating better nutritional status.

  Postoperative day 1 and the day of discharge

• Psychological Status Assessment - Geriatric Depression Scale (GDS)

  Geriatric Depression Scale-15 (Short Form): It is a scale used to screen for depression in older adults. The total score ranges from 0 to 15. Scores of 0-4 indicate no depression, 5-8 indicate mild depression, 9-11 indicate moderate depression, and 12-15 indicate severe depression.

  Postoperative day 1 and the day of discharge

Study Arms (2)

Control group

NO INTERVENTION

Standard nursing care was provided to patients in this group

Targeted Individualized Nursing Care Group

EXPERIMENTAL

An individualized nursing intervention targeting risk factors associated with frailty was planned for patients in this group

Other: Experimental

Interventions

Experimental OTHER

Targeted Individualized Nursing Care

Targeted Individualized Nursing Care Group

Eligibility Criteria

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

You may qualify if:

• Aged 65 years and older
• Scheduled for elective surgery
• Edmonton Frail Scale score ≥ 7
• Able to speak Turkish and communicate effectively
• Can be transferred from the postoperative intensive care unit to the ward
• Patients who agree to participate in the study

You may not qualify if:

• Patients with neurological or psychological disorders
• Patients who cannot be transferred from the postoperative intensive care unit to the ward
• Emergency and unplanned cases

Sponsors & Collaborators

• SELDA MERT: lead

Study Sites (1)

Eskişehir Osmangazi University Health, Practice, and Research Hospital

Eskişehir, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: Targeted Individualized Nursing Care Group (Intervention Group) Standard Care Group (Control Group)

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)