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Cognitive DysfunctionSociQ-DTNCT06476561

Impact of Sociodemographic, Psychological, and Quality of Life Factors on Dual-Task Performance in Elderly Iraqis

An observational study of Cognitive Dysfunction and Motor Skills Disorders, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the impact of sociodemographic, psychological, and quality of life factors on dual-task performance in elderly individuals living in Iraq. Dual-task performance, the ability to perform two tasks simultaneously, is a crucial indicator of cognitive and motor functions in older adults. Read more about this study

Who is it for?
Ages 60 to 89 yearsHealthy volunteers can take part
What is being tested?
- Sociodemographic Assessment - Psychological Assessment - Quality of Life Assessment - D
How many people
384 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2024to 10 May 2024
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 60 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Study Population Description: The study population consists of healthy, community-dwelling elderly individuals aged 60 and above residing in Najaf, Iraq. Participants are recruited from various community centers, healthcare facilities, and local organizations within the city. The population includes individuals from diverse sociodemographic backgrounds, ensuring a representative sample of the elderly community in Najaf. The focus is on those who are generally healthy and capable of understanding and participating in the study procedures, excluding individuals with severe physical or mental health conditions or significant cognitive impairments.

Who may be able to join

  • Age 60 years and above
  • Healthy community-dwelling individuals
  • Ability to understand and comply with study procedures
  • Willingness to provide informed consent
  • Residing in Najaf, Iraq

Who cannot join

  • Severe physical health conditions
  • Severe mental health conditions (e.g., severe depression, severe anxiety, schizophrenia)
  • Cognitive status below the Mild Cognitive Impairment (MCI) limit
  • Language barriers preventing understanding of study procedures
  • Severe communication issues
  • Unwillingness to participate
  • Presence of consciousness disorders such as dementia
  • Any condition that, in the opinion of the investigators, would interfere with the ability to complete the study or pose a risk to the participant's health

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ceyhun Türkmen

    Yenimahalle, Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Impact of Sociodemographic, Psychological, and Quality of Life Factors on Dual-Task Performance in Elderly Individuals: A Cross-Sectional Study in Iraq

This study investigates the impact of sociodemographic, psychological, and quality of life factors on dual-task performance in elderly individuals living in Iraq. Dual-task performance, the ability to perform two tasks simultaneously, is a crucial indicator of cognitive and motor functions in older adults. This research aims to understand how factors such as age, gender, education, income, mental health (depression, anxiety, and stress), mindfulness, and overall quality of life influence the ability of elderly individuals to manage dual tasks, which is essential for maintaining independence and preventing falls.

The study hypothesizes that better physical health and quality of life will be associated with improved dual-task performance, while higher levels of psychological distress may negatively impact this ability. Data were collected from 384 healthy community-dwelling elderly participants aged 60 and above in Najaf, Iraq, using validated tools such as the Depression Anxiety Stress Scales-21 (DASS-21), the Mindful Attention Awareness Scale (MAAS), and the World Health Organization Quality of Life Brief Form (WHOQOL-BREF). Dual-task performance was assessed through the Nine-Hole Peg Test (NHPT) combined with a cognitive task of counting backward by threes.

The findings from this study will provide valuable insights into the factors that affect cognitive and motor functions in the elderly, helping to inform the development of targeted interventions and policies aimed at improving the quality of life and care for Iraq's aging population. Understanding these influences is crucial for enhancing elderly care, preventing falls, supporting cognitive health, and informing policies to improve the quality of life for Iraq's aging population.

Read the detailed description

This cross-sectional study aims to explore the impact of sociodemographic, psychological, and quality of life factors on dual-task performance in elderly individuals living in Najaf, Iraq. Dual-task performance is critical for assessing cognitive and motor functions, and understanding these influences is essential for enhancing elderly care, preventing falls, supporting cognitive health, and informing policies to improve the quality of life for Iraq's aging population.

Study Hypothesis:

The study hypothesizes that better physical health and quality of life will be associated with improved dual-task performance, while higher levels of psychological distress (depression, anxiety, and stress) will negatively impact this ability.

Participants:

The study includes 384 healthy community-dwelling participants aged 60 and above, recruited from various community centers, healthcare facilities, and local organizations in Najaf, Iraq. Inclusion criteria cover individuals irrespective of gender, marital status, education level, income, socioeconomic status, urban or rural residence, and employment status. Exclusion criteria include severe physical or mental health conditions, language barriers, severe communication issues, and unwillingness to participate. Cognitive status below the Mild Cognitive Impairment (MCI) limit based on evaluator observations also led to exclusion.

Data Collection Tools:

  1. Depression Anxiety Stress Scales-21 (DASS-21): A 21-item scale assessing depression, anxiety, and stress, rated on a 4-point Likert scale.
  2. Mindful Attention Awareness Scale (MAAS): A 15-item instrument measuring mindfulness, rated on a 6-point Likert scale.
  3. World Health Organization Quality of Life - BREF (WHOQOL-BREF): A 26-item questionnaire measuring physical health, psychological health, social relationships, and environment.

Dual-Task Performance Assessment:

Participants' dual-task performance was evaluated using the Nine-Hole Peg Test (NHPT), where they place and remove nine pegs in a series of holes as quickly as possible. This motor task was combined with a cognitive task of counting backward by threes. Performance was assessed by comparing the time taken to complete the NHPT alone with the time taken while also performing the cognitive task.

Statistical Analysis:

Data were analyzed using SPSS version 23.0. Descriptive statistics summarized demographic characteristics and scale scores. Correlation analyses examined relationships between variables affecting dual-task performance. Pearson correlation coefficients were calculated for these analyses. Multivariate regression analyses were employed to isolate the independent effects of the variables on dual-task performance, with independent variables including demographic factors (age), DASS-21, MAAS, and WHOQOL-BREF scores. The regression model's goodness-of-fit was assessed using R-squared, adjusted R-squared, and F-statistic values. Regression coefficients, standard errors, and t-statistics tested the significance of predictors, with a significance level of \( p < 0.05 \) for all hypothesis tests. Data normality was evaluated using Kolmogorov-Smirnov and Shapiro-Wilk tests, confirming normal distribution. Missing data analysis ensured data integrity and completeness.

Sample Size Assessment:

A sample size of 384 participants was calculated to ensure a representative sample of the elderly population in Najaf, Iraq, with a 95% confidence level and a 5% margin of error.

Plan for Missing Data:

Missing data were addressed by determining if data were missing at random. Appropriate statistical methods were applied to handle missing data, ensuring the integrity of the dataset used in analyses.

Being tested
- Sociodemographic Assessment - Psychological Assessment - Quality of Life Assessment - D
Keywords
Dual-Task Performance, Elderly, Cognitive Function, Motor Skills, Quality of Life, Physical Health
Medical subject headings
Cognitive Dysfunction, Motor Skills Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • - Sociodemographic Assessment - Psychological Assessment - Quality of Life Assessment - DOther

    The study involves several assessments to evaluate the impact of various factors on dual-task performance in elderly individuals:

    1. Sociodemographic Assessment: Collection of data on age, gender, education, income, marital status, and other relevant factors.
    2. Psychological Assessment: Use of the Depression Anxiety Stress Scales-21 (DASS-21) to measure levels of depression, anxiety, and stress.
    3. Quality of Life Assessment: Utilization of the World Health Organization Quality of Life Brief Form (WHOQOL-BREF) to assess physical health, psychological health, social relationships, and environment.
    4. Dual-Task Performance Evaluation: Measurement of the ability to perform a cognitive task (counting backward by threes) simultaneously with a motor task (Nine-Hole Peg Test). The dual-task cost (DTC) is calculated to quantify the impact of cognitive load on motor performance.
Study groups in NCT06476561
Study groupRoleWhat they receive
Elderly Participants in IraqThis study group consists of community-dwelling elderly individuals aged 60 and above residing in Najaf, Iraq. The participants are healthy and do not have severe physical or mental health conditions. They are evaluated to understand how sociodemographic, psychological, and quality of life factors influence their dual-task performance, which includes both cognitive and motor functions. The study aims to provide insights into factors affecting their ability to perform dual tasks, contributing to the development of targeted interventions and policies for improving the quality of life and care for Iraq's aging population.
Receives: Other: - Sociodemographic Assessment - Psychological Assessment - Quality of Life Assessment - D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dual-Task Performance

    The primary outcome measure is the dual-task performance, assessed by the time taken to complete the Nine-Hole Peg Test (NHPT) while simultaneously performing a cognitive task of counting backward by threes.

    This metric characterizes the impact of cognitive load on motor performance, with higher DTC values indicating greater difficulty in managing dual tasks.

    Measured: The measurement is assessed at a single point in time during the participant's enrollment visit, immediately following the completion of both single-task and dual-task conditions.

Secondary outcomes (1)
  1. Psychological Distress Levels

    Measurement of participants' levels of depression, anxiety, and stress using the Depression Anxiety Stress Scales-21 (DASS-21). Scores are calculated for each subscale (depression, anxiety, and stress) based on participants' responses, providing insight into the psychological well-being of the elderly population and its potential association with dual-task performance.

    Measured: The measurement is assessed at a single point in time during the participant's enrollment visit, immediately following the completion of the DASS-21 questionnaire.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start1 Mar 2024
  3. Primary completion30 Apr 2024
  4. Study completion10 May 2024

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476561
Sponsor's protocol ID
1bd259b9391040ed].
Acronym
SociQ-DT
Status last verified
Jun 2024
First submitted
19 Jun 2024
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected individual participant data (IPD) that underlie the results in the publication will be shared, including data dictionaries. This will ensure that other researchers can verify the findings and conduct further analyses.

Publications

  • Abo M, Hamaguchi T. Effectiveness of a Dual-Task Intervention Involving Exercise and Vocalized Cognitive Tasks. J Clin Med. 2024 May 17;13(10):2962. doi: 10.3390/jcm13102962.

    PubMed 38792503
  • Mahmood KA, Saleh AM. Barriers and facilitators influencing access to and utilization of primary healthcare services in Kurdistan-region, Iraq: a cross-sectional study. Ann Med Surg (Lond). 2023 Jun 10;85(7):3409-3417. doi: 10.1097/MS9.0000000000000957. eCollection 2023 Jul.

    PubMed 37427184
  • Ali AM, Ahmed A, Sharaf A, Kawakami N, Abdeldayem SM, Green J. The Arabic Version of The Depression Anxiety Stress Scale-21: Cumulative scaling and discriminant-validation testing. Asian J Psychiatr. 2017 Dec;30:56-58. doi: 10.1016/j.ajp.2017.07.018. Epub 2017 Jul 18.

    PubMed 28755630
  • Baek JE, Hyeon SJ, Kim M, Cho HY, Hahm SC. Effects of dual-task resistance exercise on cognition, mood, depression, functional fitness, and activities of daily living in older adults with cognitive impairment: a single-blinded, randomized controlled trial. BMC Geriatr. 2024 Apr 24;24(1):369. doi: 10.1186/s12877-024-04942-1.

    PubMed 38658827
  • Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508. doi: 10.1155/2013/657508. Epub 2013 Sep 11.

    PubMed 24102028
  • Bowen A, Wenman R, Mickelborough J, Foster J, Hill E, Tallis R. Dual-task effects of talking while walking on velocity and balance following a stroke. Age Ageing. 2001 Jul;30(4):319-23. doi: 10.1093/ageing/30.4.319.

    PubMed 11509310

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Dysfunction and Motor Skills Disorders, run by Çankırı Karatekin 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 5 inclusion and 8 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 26 Jun 2024. 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?

Dual-Task Performance (time frame: The measurement is assessed at a single point in time during the participant's enrollment visit, immediately following the completion of both single-task and dual-task conditions.). 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 NCT06476561, which also lists 6 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 26 Jun 2024.

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