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临床试验/NCT07066202
NCT07066202招募中不适用

Impact Assessment of SALSA (Sensing and Automation for Freedom, Security, Autonomy) Technological Solutions

Fondazione Don Carlo Gnocchi Onlus1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年3月11日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
Goal Attainment Scale (GAS)

研究概览

简要总结

This study evaluates the impact of assistive technologies designed to improve the independence and safety of adults with disabilities living in shared residential environments. The project is called SALSA, which stands for "Sensorisation, Automation for Freedom, Security and Autonomy." It is being conducted in Milan, Italy, by a collaboration between Cascina Biblioteca Società Cooperativa Sociale, Fondazione Don Carlo Gnocchi ONLUS, and Informatici Senza Frontiere APS.

The goal of the study is to determine how well specific technologies-such as smart lighting systems and wearable monitoring devices-support residents' autonomy and daily functioning, while also reducing the workload for professional caregivers. These technologies are installed in apartments where people with mental, social, and/or physical disabilities live together with some support.

A total of 55 adults over the age of 18, all residents of Cascina Biblioteca's shared flats, will be enrolled. Technologies will be set up prior to the beginning of the trial. Data will be collected in three phases: before using the technologies (T0), after 30 days (T1), and after 60 days (T2). The evaluation includes personalized goals, physical environment metrics (like temperature, air quality, door use, and night movements), and ease of use of the systems by staff.

The study uses Goal Attainment Scaling (GAS) to track whether residents achieve their individual or group goals, and the System Usability Scale (SUS) to assess how user-friendly the technologies are from the caregivers' perspective. All data will be collected through structured webforms to reduce the chance of missing information and increase consistency. The study team will use both descriptive and inferential statistical methods to assess results over time.

A total of 55 adults over the age of 18, all residents of Cascina Biblioteca's shared flats, will be enrolled. Technologies will be set up prior to the beginning of the trial. Data will be collected in three phases: before using the technologies (T0), after 30 days (T1), and after 60 days (T2). The evaluation includes personalized goals, physical environment metrics (like temperature, air quality, door use, and night movements), and ease of use of the systems by staff.

The study uses Goal Attainment Scaling (GAS) to track whether residents achieve their individual or group goals, and the System Usability Scale (SUS) to assess how user-friendly the technologies are from the caregivers' perspective. All data will be collected through structured webforms to reduce the chance of missing information and increase consistency. The study team will use both descriptive and inferential statistical methods to assess results over time.

This research aims to provide practical insights into how technology can support adults with disabilities in more independent, safer living situations. It may also inform broader applications of these systems in similar care contexts. The protocol was approved by an Ethics Committee (CET 130/24; FDG 28_17/12/2024) and is in the data collection phase as of early 2025.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older than 18 years of age;
  • mental, social and/or motor disability;
  • signature of consent for participation.

排除标准

  • under 18 years of age;
  • non-signature of consent to participation.

结局指标

主要结局

Goal Attainment Scale (GAS)

时间窗: Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline

The Goal Attainment Scaling (GAS) is a scale used to measure how well individual therapy or intervention goals are achieved. It uses a 5-point scale ranging from -2 to +2, where each score reflects the degree to which the outcome met, exceeded, or fell short of expectations: +2: Outcome was much better than expected; +1: Outcome was somewhat better than expected; 0: Outcome was exactly as expected; -1: Outcome was somewhat below expectations; -2: Outcome was much worse than expected, possibly even below the starting point. This structured approach allows for personalized goal tracking and provides a standardized way to evaluate progress in a meaningful and quantifiable manner.

次要结局

  • Quantitative metrics(Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline)
  • System Usability Scale (SUS)(Evaluations will be conducted at three time points: T1: 30 days after the baseline T2: 60 days after the baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Salatino

Bioengineer

Fondazione Don Carlo Gnocchi Onlus

研究点 (1)

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