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临床试验/NCT07471945
NCT07471945进行中(未招募)不适用

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

SELDA MERT1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
75
试验地点
1
主要终点
Cognitive Function - Standardized Mini-Mental State Examination (MMSE)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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

干预措施: Experimental (Other)

结局指标

主要结局

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

时间窗: Postoperative day 1 and the day of discharge

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.

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

时间窗: Postoperative day 1 and the day of discharge

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.

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

时间窗: Postoperative day 1 and the day of discharge

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.

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

时间窗: Postoperative day 1 and the day of discharge

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.

Physical Status Assessment - Itaki Fall Risk Scale

时间窗: Postoperative day 1 and the day of discharge

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.

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

时间窗: Postoperative day 1 and the day of discharge

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.

Psychological Status Assessment - Geriatric Depression Scale (GDS)

时间窗: Postoperative day 1 and the day of discharge

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.

次要结局

未报告次要终点

研究者

发起方
SELDA MERT
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SELDA MERT

PhD

Kirsehir Ahi Evran Universitesi

研究点 (1)

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