ElderlyNCT05051319
Factors Associated With Cognitive Status in the Elderly
An observational study of Elderly, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly
- How many people
- 814 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 20 Apr 2020
- How long will I take part?
- 2 Years
- 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 65 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Central nervous system diseases affecting cognitive functions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Kınıklı/Pamukkale, 20070
About this study
Official title: Investigation of Factors Associated With Cognitive Status in the Elderly
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.
- Conditions
- Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Apr 2017
- Primary completion11 Feb 2019
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 814 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Kara, Pamukkale University
- Investigators
- Güzin Kara, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051319
- Sponsor's protocol ID
- 60116787-020/16528
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31161337Li 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 25456889Kloszewska 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Associated With Cognitive Status in the Elderly
- ClinicalTrials.gov ID
- NCT05051319
- Acronym / sponsor ID
- 60116787-020/16528
- Conditions
- Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 21 Sep 2021 (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 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Central nervous system diseases affecting cognitive functions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Center for Disease Control and Prevention Health-Related Quality of Life-4 Scale
Time frame: Two years
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.
Standardized Mini-Mental Test
Time frame: Two years
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.
Geriatric Depression Scale
Time frame: Two years
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.
Assessment of Pain
Time frame: Two years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Results publication: PubMed 31161337von 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.
- Results publication: PubMed 25456889Li 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.
- Results publication: PubMed 33572984Kloszewska 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.
- Individual participant dataSharing planned: No
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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.
Güzin Kara principal investigator
Pamukkale University
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 Elderly, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Disease Control and Prevention Health-Related Quality of Life-4 Scale (time frame: Two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051319, which also lists 3 linked publications.
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 21 Sep 2021.