NCT05051319

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
814

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

September 10, 2021

Last Update Submit

September 10, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Central nervous system diseases affecting cognitive functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Kınıklı/Pamukkale, 20070, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Güzin Kara

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investıgator

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 21, 2021

Study Start

April 1, 2017

Primary Completion

February 11, 2019

Study Completion

April 20, 2020

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations