Healthy Aging Clinical Trial
— PolSenior2Official title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Gdansk | Gdansk |
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 |
Poland,
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 |
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