Individualized Nursing Care and Frailty Outcomes in Cardiac Surgery

The Effect of Targeted Individualized Nursing Care Interventions on Frailty Levels and Clinical Outcomes in Frail Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Clinical Outcomes; Patient-centered Care; Cardiac Surgical Procedures (Postoperative Population); Frail Patient
• Intervention / Treatment: Other: Experimental

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Eskişehir, Turkey (Türkiye)
    • Eskişehir Osmangazi University Health, Practice, and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Standard nursing care was provided to patients in this group
Experimental: Targeted Individualized Nursing Care Group; An individualized nursing intervention targeting risk factors associated with frailty was planned for patients in this group	Other: Experimental; Targeted Individualized Nursing Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SELDA MERT

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Decision Number: 33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No