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临床试验/NCT05831982
NCT05831982已完成不适用

The Effect of a Complex Person-centered Exercise and Nutrition Intervention for Frail Older Patients on Functional Decline, Quality of Life and Readmissions - A Randomized Controlled Trial.

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119
试验地点
1
主要终点
Short Physical Performance Battery (SPPB)

研究概览

简要总结

The objective of this study is to evaluate the effect of a person-centered training and nutrition intervention six month after discharge in acutely admitted frail old medical patients on physical function. Secondly, to evaluate the effect on frailty, quality of life, health literacy, nutrition, readmissions, death and consumption of home care costs.

详细描述

Evidence on how to improve physical function and avoid unnecessary readmissions for frail hospitalized older medical patients is not established as yet. In Denmark, the few studies performed have not succeeded in showing a significant difference in physical function or quality of life, due to sector barriers, low compliance and uni-dimensional interventions and none of the studies addressed readmissions and or described a patient-centered approach.

This research project will address this serious individual and societal challenge by testing and evaluating a person-centered complex intervention with emphasis on the patients´ own focus and goals. To increase the probability of developing a successful intervention with the patient in focus we have completed two qualitative studies with patients and health professionals. The primary results from these studies indicate that the pedagogical approach of the involved healthcare professional is important for establishing a good relation. Patients had a desire of being more active, but after four week only a minority had their own expectations fulfilled. Furthermore, the patients expressed that social relations had the potential of increasing adherence to training sessions. Furthermore, a citizen's panel has been established, and possible elements important for the intervention were discussed on behalf of their own experiences with the healthcare system. The results of these qualitative studies and the latest evidence contributed to the development of the current intervention study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Due to the vulnerable group masking was not possible for care provider or baseline tester, but randomization will take place after baseline tests have been performed. Tester at 15 and 26 weeks will be masked.

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

  • 65+ years old
  • Acutely admitted with a medical focus at Aalborg University Hospital, South.
  • Living in Aalborg Municipality (except 9230 Svenstrup, 9240 Nibe, 9293 Kongerslev, 9381 Sulsted, and 9382 Tylstrup)
  • Able to walk (assistance is ok) before admission.
  • Speak and understand Danish.

排除标准

  • Discharged with rehabilitatinplan for physiotherapy within the last 30 days.
  • Dementia or other cognitive impairments.
  • Terminal ill.

结局指标

主要结局

Short Physical Performance Battery (SPPB)

时间窗: 26 weeks

A group of measures that combines the results of the gait speed, chair stand and balance tests

次要结局

  • Clinical Frailty Scale (CFS)(15 weeks)
  • Short Physical Performance Battery (SPPB)(15 weeks)
  • Height(Baseline)
  • Tilburg Frailty Indicator(15 weeks)
  • Other healthcare services(26 weeks.)
  • Timed Up and Go(15 weeks)
  • Grip strength(15 weeks)
  • Body mass, body fat mass and body muscle mass(15 weeks)
  • Home care(15 weeks.)
  • EQ5D-5L(15 weeks)
  • Admission(15 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurine Nilsson

Physiotherapist, PhD student

Aalborg University Hospital

研究点 (1)

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