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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04026815
Other study ID # 6/5/4.2/NPZ/2017/1203/1257
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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