- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07659457
Functional Skills Training for Supermarket Shopping Using NFC Technology in People With Intellectual Disabilities
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
A Coruña
-
A Coruña, A Coruña, Spain, 15008
- Centro de Investigación en TIC (CITIC)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- People with disabilities who regularly participate in therapy sessions.
- People with disabilities within the age range between 18 and 65 years.
- Participants who agree and have signed the informed consent to participate in the study and the authorization for data collection.
Exclusion Criteria:
- Individuals with disabilities that limit the ability to interact with the tool (e.g., severe visual, hearing, or cognitive difficulties) that significantly limit the ability to interact with the tool.
- Participants who are unable to regularly attend scheduled therapy sessions, affecting consistency in the intervention.
- Participants with unstable medical or psychological conditions who may experience aggravation of their condition due to interaction with the tool.
- Participants who are involved in other interventions or studies that may influence the results of this protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: General group
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of Performance Shown by the Participant During the Performance of the Purchase Simulation
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:
|
From enrollment to the end of treatment at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Performance Shown by the Participant while Using the "Compra con-Migo" tool
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
Score in Dependency during Purchase Activity
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). |
From enrollment to the end of treatment at 8 weeks
|
|
Total Number of Errors made by the Participant when Selecting or Scanning the Wrong Products
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Automatic registration by the application.
|
From enrollment to the end of treatment at 8 weeks
|
|
Errors at the Calculation and Payment Stage
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
Time of Completion of the Activity
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.
|
From enrollment to the end of treatment at 8 weeks
|
|
Level of Satisfaction, Usability and Quality of the "Compra con-Migo" Tool by Professionals.
Time Frame: From enrollment to the end of treatment at 8 weeks
|
A structured record designed by the researchers.
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: María Martínez Pérez, Computer Science, Universidade da Coruña
- Study Director: Betania Groba Gonzalez, Ocupational Therapy, Universidade da Coruña
- Study Director: Patricia Concheiro Moscoso, Ocupational Therapy, Universidade da Coruña
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurologic Manifestations
-
Zurich Regional Health CenterRecruitingNeurologic SymptomsSwitzerland
-
Vestre Viken Ringerike SykehusCompletedTransient Neurologic SymptomsNorway
-
Rehaklinik Zihlschlacht AGRecruiting
-
National Taiwan University HospitalRecruiting
-
Yonsei UniversityRecruitingGait Disorders, NeurologicKorea, Republic of
-
University of NebraskaTerminatedGait Disorders, NeurologicUnited States
-
The Leeds Teaching Hospitals NHS TrustCompletedGait Disorders, Neurologic
-
Istanbul Arel UniversityBahçeşehir University; Kırklareli UniversityCompletedNeurologic DeficitsTurkey (Türkiye)
-
University Hospital, GenevaCompletedMuscle Weakness | Gait, UnsteadySwitzerland
Clinical Trials on App training
-
University of Massachusetts, WorcesterCompleted
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical CenterCompletedPost Traumatic Stress DisorderUnited States
-
Rigshospitalet, DenmarkUniversity of Copenhagen; Copenhagen Academy for Medical Education and SimulationCompleted
-
Norwegian University of Science and TechnologyUllevaal University HospitalTerminated
-
Brown UniversityUniversity of Massachusetts, WorcesterCompleted
-
National Yang Ming UniversityCompletedChronic Ankle InstabilityTaiwan
-
Brown UniversityDartmouth College; Tiny Blue Dot FoundationEnrolling by invitation
-
University of TorontoOntario centre for excellence vip programCompleted
-
Insel Gruppe AG, University Hospital BernUniversity of BernRecruiting
-
Arizona State UniversityWellth Inc.CompletedHypertension | Medication Adherence | HabitsUnited States