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临床试验/NCT06570109
NCT06570109Enrolling By Invitation不适用

Association Between Decline in Functional Ability and Frailty in Community-dwelling Older Adults Living With Alzheimer's Dementia

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
130
试验地点
1
主要终点
Patient IADL Change

研究概览

简要总结

The primary aim of this study is to investigate the association between frailty as defined by the Fried Frailty Phenotype and risk of functional decline in patients with Alzheimer's dementia. The hypothesis is that frailty is associated with greater functional decline in community-dwelling older people with Alzheimer's dementia compared to those without frailty.

Secondary aims include investigation of long-term risk of institutionalization (through administrative follow-up) and trajectories of assessment components in future assessment.

The study is designed as a prospective cohort study. Participants in the study will undergo an assessment battery at baseline, 1 years of follow-up, and administrative follow-up for 5 years.

Participants will be recruited from patients of the Unit of Dementia at Aalborg University Hospital within 3 months of dementia diagnosis. The time frame of 3 months after diagnosis was chosen to ensure that cognitive assessment in the Unit of Dementia was reflective of patient's cognitive level and thereby ability to consent at inclusion. Patients will be eligible for inclusion if they are 65 years or older, have a diagnosis of mild or moderate Alzheimer's or mixed (Alzheimer's and vascular) dementia, live at home, and are able to walk 5 meters independently of other people (walking aids will be allowed). The severity of dementia will be defined according to score on the Mini Mental State Examination (MMSE) as it has done in other studies. According to this definition a MMSE score between 20-30 indicates mild Alzheimer's dementia and a MMSE score from 15-19 indicates moderate dementia. People with moderately severe and severe Alzheimer's dementia defined as MMSE score below 15 will not be eligible to participate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Diagnosis of Alzheimers Dementia
  • MMSE > 14
  • Age >= 65
  • Not living in institution
  • Able to walk 5m without assistence (walking aids accepted)

排除标准

  • No available caregiver/proxy
  • Unable to give informed consent as judged by caregiver/proxy or researcher
  • Time from diagnosis > 3 months

结局指标

主要结局

Patient IADL Change

时间窗: 1 year

Defined by patient reported ADL performance on the Functional Activities Questinnaire

Caregiver IADL Change

时间窗: 1 year

Defined by caregiver reported ADL performance on the Functional Activities Questinnaire

Caregiver BADL Change

时间窗: 1 year

Defined by caregiver reported ADL performance on Barthel ADL scale

Patient BADL Change

时间窗: 1 year

Defined by patient reported ADL performance on Barthel ADL scale

次要结局

  • Nursing home admission(5 years)
  • Mortality(5 years)

研究者

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

Johannes Riis

MD

Aalborg University Hospital

研究点 (1)

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