- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07066202
- Original Trial
Impact Assessment of SALSA (Sensing and Automation for Freedom, Security, Autonomy) Technological Solutions
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Italy
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Milan, Italy, Italy
- Recruiting
- Cascina Biblioteca Società Cooperativa Sociale
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Contact:
- Marianna Guzzetti
- Phone Number: +39
- Email: marianna.guzzetti@cascinabiblioteca.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- older than 18 years of age;
- mental, social and/or motor disability;
- signature of consent for participation.
Exclusion Criteria:
- under 18 years of age;
- non-signature of consent to participation.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal Attainment Scale (GAS)
Time Frame: 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. |
Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative metrics
Time Frame: Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline
|
In addition to the Goal Attainment Scaling (GAS), the study will collect a range of quantitative metrics to better understand the impact of innovative technological solutions on the daily lives of individuals with disabilities.
These metrics will include environmental conditions (e.g., indoor temperature), safety-related indicators (e.g., number of emergency situations, unintended door openings, lack of ventilation), and the frequency of critical events (e.g., falls, water leaks).
This data will provide objective context to complement the subjective assessment of goal achievement, allowing for a more comprehensive evaluation of the interventions' effectiveness and their influence on everyday living conditions.
|
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)
Time Frame: Evaluations will be conducted at three time points: T1: 30 days after the baseline T2: 60 days after the baseline
|
The System Usability Scale (SUS) is a widely used tool for assessing user experience, specifically focusing on usability. It yields a score ranging from 0 to 100, where higher scores indicate a more favorable perception of usability. A SUS score above 68 is generally considered above average. How the SUS Score is Calculated: Collect Responses: Participants answer 10 items using a 5-point Likert scale (from 1 = strongly disagree to 5 = strongly agree). Score Odd-Numbered Items (1, 3, 5, 7, 9): subtract 1 from the participant's response. Score Even-Numbered Items (2, 4, 6, 8, 10): subtract the participant's response from 5. Sum the Adjusted Scores: add all the adjusted values together. Multiply by 2.5: the total is multiplied by 2.5 to obtain the final SUS score (ranging from 0 to 100). SUS Score Interpretation Guide: 0-50: Poor (Awful); 51-67: Below Average (Poor); 68-71: Marginal (Okay); 72-80: Good; 80 and above: Excellent. |
Evaluations will be conducted at three time points: T1: 30 days after the baseline T2: 60 days after the baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CET 130/24, FDG 28_17/12/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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