Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT06476561
Brief 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. 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.
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.
Study:
NCT06476561
Study Brief:
Protocol Section:
NCT06476561