Aging DisorderPolSenior2NCT04026815
Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide PolSenior2 Survey.
An observational study of Aging Disorder and Age Problem, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The PolSenior2 survey is aimed to characterise health status of old and very-old adults in Poland. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Disorder, Age Problem, Healthy Aging
- What is being tested?
- medical history, blood and urine tests
- How many people
- 6,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- over 60 years of age,
- randomly selected from database of all Polish citizens,
- consent to participate in the study.
Who cannot join
- under 60 years of age,
- no consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk
Gdansk
Tomasz R. Zdrojewski, MD, Prof, +48 58 3491975, tz@gumed.edu.pl
Lukasz Wierucki, MD, PhD, +48 58 3491975, wierucki@gumed.edu.pl
About this study
Official 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.
Read the 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.
- Conditions
- Aging Disorder, Age Problem, Healthy Aging, Immunity Disorders, Frailty Syndrome, Behaviors, Health
- Being tested
- medical history, blood and urine tests
- Medical subject headings
- Immune System Diseases, Frailty, Health Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical history, blood and urine testsOther
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: medical history, blood and urine 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. Receives: Other: medical history, blood and urine 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. Receives: Other: medical history, blood and urine 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. Receives: Other: medical history, blood and urine 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. Receives: Other: medical history, blood and urine 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. Receives: Other: medical history, blood and urine 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. Receives: Other: medical history, blood and urine tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Comorbidities incidence
the prevalence of comorbidities
Measured: 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"
Measured: baseline
Sarkopenia incidence
The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).
Measured: baseline
Secondary outcomes (8)
Number of drugs taken
assessement of pharmacotherapy and polypragmasy
Measured: baseline
Medical care availability
number of hospitalizations and of outpatients visits in last five years
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS)
measurement by the Pain Assessment Scale (PAS)
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland, Medical University of Silesia, Jagiellonian University, International Institute of Molecular and Cell Biology in Warsaw, SGH Warsaw School of Economics, Medical University of Lodz, National Institute of Public Health, National Research Institute, Poland
- Responsible party
- Principal investigator, Tomasz Zdrojewski, Medical University of Gdansk
- Investigators
- Tomasz R. Zdrojewski, MD, Prof, Principal investigator, Medical University of Gdansk, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026815
- Sponsor's protocol ID
- 6/5/4.2/NPZ/2017/1203/1257
- Acronym
- PolSenior2
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide, Cross-sectional PolSenior2 Survey.
- ClinicalTrials.gov ID
- NCT04026815
- Acronym / sponsor ID
- PolSenior2 / 6/5/4.2/NPZ/2017/1203/1257
- Conditions
- Aging Disorder, Age Problem, Healthy Aging, Immunity Disorders, Frailty Syndrome, Behaviors, Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland, Medical University of Silesia, Jagiellonian University, International Institute of Molecular and Cell Biology in Warsaw, SGH Warsaw School of Economics, Medical University of Lodz, National Institute of Public Health, National Research Institute, Poland
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PolSenior2 survey is aimed to characterise health status of old and very-old adults in Poland.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 60 - 65 years | – | Other: medical history, blood and urine testsSubjects 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. |
| 65 - 69 years | – | Other: medical history, blood and urine testsSubjects 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. |
| 70 - 74 years | – | Other: medical history, blood and urine testsSubjects 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. |
| 75 - 79 years | – | Other: medical history, blood and urine testsSubjects 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. |
| 80 - 84 years | – | Other: medical history, blood and urine testsSubjects 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. |
| 85 - 89 years | – | Other: medical history, blood and urine testsSubjects 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. |
| ≥90 years | – | Other: medical history, blood and urine testsSubjects 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- over 60 years of age,
- randomly selected from database of all Polish citizens,
- consent to participate in the study.
Key exclusion criteria (2 listed)
- under 60 years of age,
- no consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical history, blood and urine testsThe study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests. | Other | 60 - 65 years, 65 - 69 years, 70 - 74 years, 75 - 79 years, 80 - 84 years, 85 - 89 years, ≥90 years |
Primary outcome
Functional status as assessed by Vulnerable Elders Survey-13
Time frame: baseline
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.
Functional status as assessed by Instrumental Activity of Daily Living
Time frame: baseline
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).
Functional status as assessed by Activity of Daily Living Index
Time frame: baseline
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.
Mood deterioration incidence
Time frame: baseline
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.
Cognitive functions as assessed by the Mini Mental State Examination
Time frame: baseline
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.
Cognitive functions as assessed by Clock Drawing Test
Time frame: baseline
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.
Comorbidities incidence
Time frame: baseline
the prevalence of comorbidities
Nutritional status assessed by the Mini Nutritional Assessment questionnaire (MNA)
Time frame: baseline
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"
Sarkopenia incidence
Time frame: baseline
The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).
8 secondary outcomes
Number of drugs taken
Time frame: baseline
Medical care availability
Time frame: five years back from baseline
Quality of life as assessed by the World Health Organization Quality of Life Age (WHOQOL-AGE)
Time frame: baseline
Quality and patterns of sleep assessmed by the Pittsburgh Sleep Quality Index
Time frame: baseline
Alcohol abuse assessment
Time frame: baseline
Physical activity assessmed by the Seven-Day Recall Physical Activity Questionnaire (PAR)
Time frame: baseline
Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS)
Time frame: baseline
Presence and severity of chronic pain assessmed by the Visual Analog Scale (VAS)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz R. Zdrojewski, MD, Prof principal investigator
Medical University of Gdansk, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging Disorder and Age Problem, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasz R. Zdrojewski, MD, Prof (+48 58 3491975, tz@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status as assessed by Vulnerable Elders Survey-13 (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.