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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05051319
Other study ID # 60116787-020/16528
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date April 20, 2020

Study information

Verified date September 2021
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study was to investigate the factors related to cognitive status in elderly individuals living in the community. A total of 841 elderly (female: 422, male: 419) living in the community were included in this cross-sectional study. The sociodemographic information of the elderly was recorded. In addition, cognitive status, quality of life, depression and musculoskeletal pain were questioned. The classification and regression tree analysis was used to identify factors associated with cognitive status. Age, depression, quality of life, neck pain, and headache were determinative on the cognitive status of the elderly. Knowing the factors related to cognitive status in elderly individuals living in the community is very important in terms of early diagnosis of factors that may affect the quality of life of these individuals.


Description:

Aim: The aim of this study was to investigate the factors related to cognitive status in elderly individuals living in the community. Methods: A total of 841 elderly (female: 422, male: 419) living in the community were included in this cross-sectional study. The sociodemographic information of the elderly was recorded. In addition, cognitive status, quality of life, depression and musculoskeletal pain were questioned. The classification and regression tree analysis was used to identify factors associated with cognitive status.


Recruitment information / eligibility

Status Completed
Enrollment 814
Est. completion date April 20, 2020
Est. primary completion date February 11, 2019
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Participants over the age of 65, - Living at home, - Not having mental and communication problems that would prevent the evaluations, - Volunteering to participate in the study. Exclusion Criteria: - Central nervous system diseases affecting cognitive functions.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Pamukkale University Denizli Kinikli/Pamukkale

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Kloszewska M, Lyszczarz B, Kedziora-Kornatowska K. Sociodemographic and Health-Related Factors Associated with Severity of Cognitive Impairment in Elderly Patients Hospital-ized in a Geriatric Clinic. Brain Sci. 2021 Jan 29;11(2). pii: 170. doi: 10.3390/b — View Citation

Li CL, Hsu HC. Cognitive function and associated factors among older people in Taiwan: age and sex differences. Arch Gerontol Geriatr. 2015 Jan-Feb;60(1):196-200. doi: 10.1016/j.archger.2014.10.007. Epub 2014 Oct 17. — View Citation

von Arnim CAF, Bartsch T, Jacobs AH, Holbrook J, Bergmann P, Zieschang T, Polidori MC, Dodel R. Diagnosis and treatment of cognitive impairment. Z Gerontol Geriatr. 2019 Jul;52(4):309-315. doi: 10.1007/s00391-019-01560-0. Epub 2019 Jun 3. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Center for Disease Control and Prevention Health-Related Quality of Life-4 Scale The quality of life of the elderly participants was evaluated with the first question of the CDC HRQOL-4 scale. The Turkish validity-reliability study of the scale is a short and understandable scale used to evaluate the quality of life. This scale consists of 4 questions evaluating the general health of the participants, their physical and mental health in the last 30 days, and how activities such as self-care, work, school, and hobbies have been affected by their physical or mental problems in the last 30 days. In question 1, general health was defined as excellent, very good, good, fair, and poor. In the 2nd, 3rd, and 4th questions, the number of days in the last 30 days when the participant felt unwell physically and mentally, and the number of days the person could not perform his daily activities due to physical and/or mental problems are recorded. Two years
Primary Standardized Mini-Mental Test Standardized Mini-Mental Test was applied to determine the cognitive levels of the participants. For the illiterate elderly, SMMT, which is used for the uneducated, was applied in our study. In this test, orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points) were collected under 5 main headings. It consists of 11 items and is evaluated over a total of 30 points. Results; 27-30 points are within normal limits, 24-27 points are mild cognitive impairment, below 24 points are considered severe cognitive impairment. The Turkish validity and reliability study of the questionnaire was conducted in 2002. Two years
Primary Geriatric Depression Scale The scale was prepared for the geriatric individuals to easily mark and answer "yes" or "no". It consists of 30 questions. In the scoring of the scale, 1 point is given for each response in favor of depression and 0 point is given for the other answer, and the result is accepted as the depression score. Scoring of the scale was made as "no depression" with 0-10 points, "possible depression" with 11 points, and "definite depression" with 14 and above points. When 14 is taken as the threshold value for Geriatric Depression Scale scores, its specificity approaches 100%. A validity and reliability study of the Geriatric Depression Scale was conducted in the Turkish elderly population. Two years
Primary Assessment of Pain The chronic pain status in 10 different body regions of the individuals were assessed in the study. The presence of pain (present or absent) and severity of pain in geriatric individuals were evaluated with a 6-point Likert-type scale (0=no pain, 1=mild, 2=moderate, 3=severe, 4=very severe, 5=unbearable). This pain scale was preferred in order to make it easier for geriatric individuals to understand the severity of pain. Two years
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