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CompletedNCT05051319Updated Sep 21, 2021

Factors Associated With Cognitive Status in the Elderly

An observational study in Elderly, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.

Sponsored by Pamukkale University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
814
Ages
65 Years and older
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Elderly
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In context

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Elderly participants was included the study residing in the city center of Denizli, living at home, having no communication and mental disability problems that would affect the evaluations, and giving informed consent.

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

Exclusion Criteria:

  • Central nervous system diseases affecting cognitive functions.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
814 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Elderly participants living at home

    Participants over the age of 65, living at home, not having mental and communication problems that would prevent the evaluations, and volunteering to participate in the study. The sociodemographic information of the participants such as gender, duration of education, living environment and people with whom they live were recorded. In addition, information about the medical condition of geriatric individuals, such as body mass indexes and the number of drugs used, was also recorded in the form. In order to evaluate the cognitive status of the participants, the Standardized or Standardized Mini-Mental Test for the Uneducated was used according to their educational status. The Center for Disease Control Health-Related Quality of Life-4 Scale (CDC HRQoL-4) was used to assess quality of life, and the Geriatric Depression Scale was used to assess emotional status. In addition, the presence of pain and pain levels according to body regions were determined with a 6-point Likert-type scale.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Two years

  2. 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.

    Time frame: Two years

  3. 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.

    Time frame: Two years

  4. 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.

    Time frame: Two years

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Study locations

1 site
  • Pamukkale University
    Denizli, Kınıklı/Pamukkale 20070, Turkey
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References and documents

Publications

  • 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. PubMed 31161337 ↗
  • 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. PubMed 25456889 ↗
  • 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):170. doi: 10.3390/brainsci11020170. PubMed 33572984 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05051319
Lead sponsor
Pamukkale University
Responsible party
Güzin Kara (Principal Investıgator, Pamukkale University) — Principal investigator
First posted
Sep 21, 2021
Start date
Apr 1, 2017
Primary completion
Feb 11, 2019
Completion
Apr 20, 2020
Last update
Sep 21, 2021

Study contacts

Güzin Kara
principal investigator · Pamukkale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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