- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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A Coruña
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A Coruña, A Coruña, Espanha, 15008
- Centro de Investigación en TIC (CITIC)
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Level of Performance Shown by the Participant During the Performance of the Purchase Simulation
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of Performance Shown by the Participant while Using the "Compra con-Migo" tool
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: María Martínez Pérez, Computer Science, Universidade da Coruña
- Diretor de estudo: Betania Groba Gonzalez, Ocupational Therapy, Universidade da Coruña
- Diretor de estudo: Patricia Concheiro Moscoso, Ocupational Therapy, Universidade da Coruña
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-023
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