Brief Summary

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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

6,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

January 1, 2018

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed

Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 15, 2019

Last Update Submit

July 17, 2019

Conditions

Aging Disorder Age Problem Healthy Aging Immunity Disorders Frailty Syndrome Behaviors, Health Health Care Utilization

Outcome Measures

Primary Outcomes (9)

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
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
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
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
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
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
Comorbidities incidence
the prevalence of comorbidities
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"
baseline
Sarkopenia incidence
The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).
baseline

Secondary Outcomes (8)

Number of drugs taken
baseline
Medical care availability
five years back from baseline
Quality of life as assessed by the World Health Organization Quality of Life Age (WHOQOL-AGE)
baseline
Quality and patterns of sleep assessmed by the Pittsburgh Sleep Quality Index
baseline
Alcohol abuse assessment
baseline
+3 more secondary outcomes

Study Arms (7)

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.