An observational study in Aging Disorder, Age Problem and Healthy Aging, sponsored by Medical University of Gdansk. Status unknown at 1 site in Poland. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by Medical University of Gdansk · Observational
The PolSenior2 survey is aimed to characterise health status of old and very-old adults in Poland.
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.
279 studies on the registry are indexed under Immune System Diseases; 81 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 316 across 82 observational studies indexed under Immune System Diseases.
Browse Immune System Diseases studies →Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.
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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.
Exclusion Criteria:
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
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
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
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
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
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
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Comorbidities incidence
the prevalence of comorbidities
Time frame: 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"
Time frame: baseline
Sarkopenia incidence
The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).
Time frame: baseline
Number of drugs taken
assessement of pharmacotherapy and polypragmasy
Time frame: baseline
Medical care availability
number of hospitalizations and of outpatients visits in last five years
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS)
measurement by the Pain Assessment Scale (PAS)
Time frame: 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.
Time frame: baseline
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Medical University of Gdansk