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

Healthy Aging Clinical Trial

— PolSenior2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026815
• Other study ID #: 6/5/4.2/NPZ/2017/1203/1257
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Medical University of Gdansk
• Contact: Tomasz R. Zdrojewski, MD, Prof
• Phone: +48 58 3491975
• Email: tz[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age Problem
• Aging Disorder
• Behaviors, Health
• Disease
• Frailty
• Frailty Syndrome
• Health Care Utilization
• Healthy Aging
• Immune System Diseases
• Immunity Disorders

Intervention

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.

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (8)

Lead Sponsor	Collaborator
Medical University of Gdansk	International Institute of Molecular and Cell Biology in Warsaw, Jagiellonian University, Medical University of Lodz, Medical University of Silesia, Ministry of Health, Poland, National Institute of Public Health-National Institute of Hygiene, SGH Warsaw School of Economics

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Comorbidities incidence	the prevalence of comorbidities	baseline
Primary	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
Primary	Sarkopenia incidence	The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).	baseline
Secondary	Number of drugs taken	assessement of pharmacotherapy and polypragmasy	baseline
Secondary	Medical care availability	number of hospitalizations and of outpatients visits in last five years	five years back from baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS)	measurement by the Pain Assessment Scale (PAS)	baseline
Secondary	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