Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide PolSenior2 Survey. (PolSenior2)

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy Aging; Age Problem; Frailty Syndrome; Immunity Disorders; Health Care Utilization; Aging Disorder; Behaviors, Health
• Intervention / Treatment: Other: medical history, blood and urine tests

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.

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • Recruiting
    • Medical University of Gdansk
    • Contact: Tomasz R. Zdrojewski, MD, Prof; Phone Number: +48 58 3491975; Email: tz@gumed.edu.pl
    • Contact: Lukasz Wierucki, MD, PhD; Phone Number: +48 58 3491975; Email: wierucki@gumed.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
60 - 65 years; Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.	Other: medical history, blood and urine tests; The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
65 - 69 years; Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.	Other: medical history, blood and urine tests; The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
70 - 74 years; Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.	Other: medical history, blood and urine tests; The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
75 - 79 years; Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.	Other: medical history, blood and urine tests; The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
80 - 84 years; Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.	Other: medical history, blood and urine tests; The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
85 - 89 years; Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.	Other: medical history, blood and urine tests; The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
≥90 years; Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.	Other: medical history, blood and urine tests; The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status as assessed by Vulnerable Elders Survey-13	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.	baseline
Functional status as assessed by Instrumental Activity of Daily Living	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).	baseline
Functional status as assessed by Activity of Daily Living Index	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.	baseline
Mood deterioration incidence	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.	baseline
Cognitive functions as assessed by the Mini Mental State Examination	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.	baseline
Cognitive functions as assessed by Clock Drawing Test	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.	baseline
Comorbidities incidence	the prevalence of comorbidities	baseline
Nutritional status assessed by the Mini Nutritional Assessment questionnaire (MNA)	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"	baseline
Sarkopenia incidence	The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of drugs taken	assessement of pharmacotherapy and polypragmasy	baseline
Medical care availability	number of hospitalizations and of outpatients visits in last five years	five years back from baseline
Quality of life as assessed by the World Health Organization Quality of Life Age (WHOQOL-AGE)	The WHOQOL-AGE has been designed and validated to measure quality of life older adults. It provides a single score that ranges on a 0-100 scale, with higher scores indicating higher quality of life.	baseline
Quality and patterns of sleep assessmed by the Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index has been designed and validated to assess the presence of sleep disorders. It includes 19 questions that combine to evaluate 7 components of sleep, each evaluated from 0 to 3 (0 = no difficulty, 3 = severe difficulty). A total score greater than 5 indicates a sleep disorder.	baseline
Alcohol abuse assessment	Alcohol abuse will be assessed using the Short Michigan Alcohol Screening (SMASM). This 10 item inventory characterizes behavior associated with alcoholism, the higher the score, the greater the severity of alcoholism in a respondent.	baseline
Physical activity assessmed by the Seven-Day Recall Physical Activity Questionnaire (PAR)	Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. Low time span (low number of minutes) spent on physical activity suggest low level of it and is one of significant symptoms of frailty syndrome.	baseline
Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS)	measurement by the Pain Assessment Scale (PAS)	baseline
Presence and severity of chronic pain assessmed by the Visual Analog Scale (VAS)	VAS is a self-assessed maximum pain reported using a 0-100 mm visual analog scale, where 100 signifies maximum pain.	baseline

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Collaborators: Jagiellonian University; Medical University of Lodz; Medical University of Silesia; Ministry of Health, Poland; International Institute of Molecular and Cell Biology in Warsaw; SGH Warsaw School of Economics; National Institute of Public Health-National Institute of Hygiene
• Investigators: Principal Investigator: Tomasz R. Zdrojewski, MD, Prof, Medical University of Gdansk, Poland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Frailty; Immune System Diseases
• Other Study ID Numbers: 6/5/4.2/NPZ/2017/1203/1257

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No