Centro de Investigación en TIC (CITIC)
A Coruña, 15008, Spain
NCT Number: NCT07659457
The general objective of the "Compra con-Migo" project is to evaluate the impact of a technological tool based on NFC (Near Field Communication) technology on the development of cognitive and instrumental skills necessary to carry out the activity of shopping in supermarkets in people with intellectual disabilities. Specifically, it is intended to analyze the evolution of performance in tasks such as planning, product recognition, calculation, payment and functional autonomy, after the use of an adapted gamified application.
The research is structured as a pilot, analytical, longitudinal and prospective study, without a control group, with evaluations in three moments: pre-intervention, intermediate and post-intervention. This methodological decision responds both to ethical criteria, by avoiding denying a potentially beneficial intervention, and to logistical limitations typical of institutional environments. Statistical analysis will be performed with R, using analysis tools for repeated measurements, both parametric and non-parametric, as appropriate.
The study population is composed of adults with intellectual disabilities, aged between 18 and 65 years, who regularly take part in therapy sessions in specialized centers. A sample of between 34 and 40 participants is expected. The intervention will be carried out in various Care Centers for People with Disabilities (CAPD) and associations in Galicia (Spain), specifically in the CAPD of A Coruña, Chapela, Sarria, Souto de Leixa and the O Saiar Occupational Center.
This study will not only evaluate the use of the tool in real environments, but also generate evidence applicable to its future implementation in other contexts. The proposal is aligned with the principles of accessibility, technological innovation and social inclusion, and seeks to offer a structured, motivating and effective therapeutic resource.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
A Coruña, 15008, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention will take place over eight weeks, with a frequency of two weekly sessions in which participants will work with the "Compra con-Migo" (Shop with Me) application. Each session will be supervised by the center's professional, ensuring that the participant can interact with the application autonomously to the best of their ability. The following elements will be required for the development of each session:
After completing four weeks of intervention, an intermediate evaluation will be carried out to analyze the progress made so far. In addition, a proprietary evaluation tool will be applied.
Time frame: From enrollment to the end of treatment at 8 weeks
The Basic Everyday Living Skills (BELS) scale will be administered. Standardized and validated tool in the Spanish context designed to assess changes in the performance of daily living skills. It is made up of 26 questions, each of which describes a specific behavior. Each question is divided into two scales:
Time frame: From enrollment to the end of treatment at 8 weeks
A structured observation log designed by the investigators will be administered, attached by ad hoc observation record.
Time frame: From enrollment to the end of treatment at 8 weeks
The Lawton and Brody Scale will be used for the Instrumental Activities of Daily Living. A standardized and validated tool in the Spanish context designed to assess the degree of functional autonomy of a person in the performance of instrumental tasks necessary to live independently in the community.
This scale allows you to identify limitations in activities that are more complex than the basic ones, such as: using the telephone, preparing meals or making purchases. Each item is scored based on the level of independence or dependence with which the person performs the task, giving rise to a total score that allows the level of autonomy of the person being evaluated to be categorized, from 0 (total dependence) to 8 (independence).
Time frame: From enrollment to the end of treatment at 8 weeks
Automatic registration by the application.
Time frame: From enrollment to the end of treatment at 8 weeks
Number of errors when making the payment (incorrect use of coins/notes, wrong scanning). Automatic registration by the application.
Time frame: From enrollment to the end of treatment at 8 weeks
Total time (in seconds) from the start to the end of the shopping list.
Time frame: From enrollment to the end of treatment at 8 weeks
A structured record designed by the researchers.
Universidade da Coruña
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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