NCT07659457

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 8, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

adaptive technologyNFCIntellectual DisabilitiesPhysical Disabilitiesgamification

Outcome Measures

Primary Outcomes (1)

  • Level of Performance Shown by the Participant During the Performance of the Purchase Simulation

    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: * A three-part scale on the degree of opportunity to carry out activities independently. * A five-part scale on the actual level of completion of each activity of daily living.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

  • Quality of Performance Shown by the Participant while Using the "Compra con-Migo" tool

    From enrollment to the end of treatment at 8 weeks

  • Score in Dependency during Purchase Activity

    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

    From enrollment to the end of treatment at 8 weeks

  • Errors at the Calculation and Payment Stage

    From enrollment to the end of treatment at 8 weeks

  • Time of Completion of the Activity

    From enrollment to the end of treatment at 8 weeks

  • +1 more secondary outcomes

Study Arms (1)

General group

EXPERIMENTAL
Other: App training

Interventions

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: * Intervention record document. * Tablet with the "Compra con-Migo" app installed. * Baskets. * Physical objects in representation of purchase products. The user will carry out the intervention, which will consist of completing five shopping lists pre-designed by the research team. Each list will involve scanning 5 objects and simulating a payment. 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.

General group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Investigación en TIC (CITIC)

A Coruña, A Coruña, 15008, Spain

Location

MeSH Terms

Conditions

Intellectual DisabilityNeurologic Manifestations

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 22, 2026

Study Start

June 2, 2025

Primary Completion

November 21, 2025

Study Completion

November 23, 2025

Last Updated

June 22, 2026

Record last verified: 2026-06

Locations