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临床试验/NCT04026815
NCT04026815Unknown不适用

Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide, Cross-sectional PolSenior2 Survey.

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
6,000
试验地点
1
主要终点
Functional status as assessed by Instrumental Activity of Daily Living

研究概览

简要总结

The PolSenior2 survey is aimed to characterise health status of old and very-old adults in Poland.

详细描述

One of the goals is assessing the prevalence and control of age-related diseases and of the "geriatric giants" (immobility, instability, incontinence, sensory deficiency, cognition and mood disorders) which lead to frailty, disability and dependence. Monitoring of health status, health behaviors and identifying socio-economic factors favoring successful aging will be significant. As the polypragmasy and adverse drug reactions remain a significant issue in the geriatric care, pharmacotherapy and medical adherence will also be examined.

The additional purpose of the study is to evaluate the utilization and access to health care and social services in respect to needs for assistance and long-term care, as well as the level and different forms of these needs.

The project is planned as a cross-sectional survey of representative sample of 6000 people aged 60 years and over. The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, anthropometric and blood pressure measurements and laboratory tests. The data are collected by well-trained nurses during three visits at respondents homes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • over 60 years of age,
  • randomly selected from database of all Polish citizens,
  • consent to participate in the study.

排除标准

  • under 60 years of age,
  • no consent to participate in the study.

结局指标

主要结局

Functional status as assessed by Instrumental Activity of Daily Living

时间窗: baseline

This will be assessed using the Instrumental Activity of Daily Living (IADL-Lawton) instrument. IADL evaluates independent living skills. Each activity has specific level of participation that can be selected. Scores range from 0 (low function, dependent) to 8 points (high function, independent).

Functional status as assessed by Vulnerable Elders Survey-13

时间窗: baseline

The Vulnerable Elders Survey-13 (VES-13) is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.

Functional status as assessed by Activity of Daily Living Index

时间窗: baseline

This will be assessed using the Activity of Daily Living (ADL-Katz Index) instrument. ADL evaluates functional status as a measurement of the patient's ability to perform activities of daily living. Each activity is rated as being completed independently or not. Scores range is 0-6 points, higher score is better.

Mood deterioration incidence

时间窗: baseline

The Geriatric Depression Scale (GDS) is a 15-item self-report assessment designed specifically to identify symptoms of depression in the elderly. Participants are asked to respond by answering yes or no in reference to how they felt over the past 2 weeks. The score 5 and more suggests the suspicion of depression, higher scores indicate more severe depressive syndrome. The final diagnosis of depression needs clinical assessment.

Cognitive functions as assessed by the Mini Mental State Examination

时间窗: baseline

The Mini Mental State Examination (MMSE) investigates specific cognitive functions. Scale range: 0-30. The score 23 and below indicates significant deterioration of cognitive functions and dementia. Score between 24-27 indicates mild cognitive impairment. Normal score ranges between 28-30.

Cognitive functions as assessed by Clock Drawing Test

时间窗: baseline

The Clock Drawing Test is a test used for the assessment of cognitive impairment based on sketches of a clock completed by a patient. The assessment is based on identifying abnormalities in the drawings, which may include poor number positioning, omission of numbers, incorrect sequencing, missing clock hands and the presence of irrelevant writing. According to Sunderland the score is: 0-10. Higher score indicates normal cognitive functions.

Nutritional status assessed by the Mini Nutritional Assessment questionnaire (MNA)

时间窗: baseline

The MNA is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. The Screening score(max. 14 points) is 12-14 points indicates "Normal nutritional status", 8-11 points indicates "At risk of malnutrition", 0-7 points indicates "Malnourished". For the full assessment there are proposed scores: 24 pts and more "Normal nutritional status"; 23,5-17 "At risk of malnutrition"; below 17 - malnourished"

Comorbidities incidence

时间窗: baseline

the prevalence of comorbidities

Sarkopenia incidence

时间窗: baseline

The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).

次要结局

  • Number of drugs taken(baseline)
  • Quality of life as assessed by the World Health Organization Quality of Life Age (WHOQOL-AGE)(baseline)
  • Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS)(baseline)
  • Presence and severity of chronic pain assessmed by the Visual Analog Scale (VAS)(baseline)
  • Quality and patterns of sleep assessmed by the Pittsburgh Sleep Quality Index(baseline)
  • Medical care availability(five years back from baseline)
  • Alcohol abuse assessment(baseline)
  • Physical activity assessmed by the Seven-Day Recall Physical Activity Questionnaire (PAR)(baseline)

研究者

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

Tomasz Zdrojewski

M.D., Ph.D., Assoc. Prof.

Medical University of Gdansk

研究点 (1)

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