Clinical trial NCT04026815: Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide PolSenior2 Survey.
Official title: Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide, Cross-sectional PolSenior2 Survey.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aging Disorder
Age Problem
Healthy Aging
Immunity Disorders
Frailty Syndrome
Behaviors, Health
Health Care Utilization
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Poland
name: Medical University of Silesia
name: Jagiellonian University
name: International Institute of Molecular and Cell Biology in Warsaw
name: SGH Warsaw School of Economics
name: Medical University of Lodz
name: National Institute of Public Health-National Institute of Hygiene
First posted: 2019-07-19
Enrollment: 6000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research population is assumed to include 6000 individuals in seven equivalent age cohorts (60-64 years, 65-69 years, 70-74 years, 75-79 years, 80-84 years, 85-89 years, 90+ years old) with equal representation of males and females in each of them.

Research participants were randomly recruited in a stratified, proportional draw. The pattern for respondent selection was designed to obtain a population representative for Polish old citizens.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Functional status as assessed by Vulnerable Elders Survey-13
timeFrame: baseline
measure: Functional status as assessed by Instrumental Activity of Daily Living
timeFrame: baseline
measure: Functional status as assessed by Activity of Daily Living Index
timeFrame: baseline
measure: Mood deterioration incidence
timeFrame: baseline
measure: Cognitive functions as assessed by the Mini Mental State Examination
timeFrame: baseline
measure: Cognitive functions as assessed by Clock Drawing Test
timeFrame: baseline
measure: Comorbidities incidence
timeFrame: baseline
measure: Nutritional status assessed by the Mini Nutritional Assessment questionnaire (MNA)
timeFrame: baseline
measure: Sarkopenia incidence
timeFrame: baseline
Secondary outcomes:
measure: Number of drugs taken
timeFrame: baseline
measure: Medical care availability
timeFrame: five years back from baseline
measure: Quality of life as assessed by the World Health Organization Quality of Life Age (WHOQOL-AGE)
timeFrame: baseline
measure: Quality and patterns of sleep assessmed by the Pittsburgh Sleep Quality Index
timeFrame: baseline
measure: Alcohol abuse assessment
timeFrame: baseline
measure: Physical activity assessmed by the Seven-Day Recall Physical Activity Questionnaire (PAR)
timeFrame: baseline
measure: Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS)
timeFrame: baseline
measure: Presence and severity of chronic pain assessmed by the Visual Analog Scale (VAS)
timeFrame: baseline
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
Study officials:
affiliation: Medical University of Gdansk, Poland
name: Tomasz R. Zdrojewski, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: