ClinicalTrials.gg
CompletedNCT05777915Updated Mar 21, 2023

SOSteniamoci: Usability Study

An observational study in Internet-based Intervention, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by Istituto Auxologico Italiano · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
10
Ages
18 Years and older
Sex
All
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Study summary

The goal of this observational study is to test the usability of the SOSteniamoci platform, culturally adapted from the Lithuanian context, for informal caregivers in Italy.

The main goals were to (1) collect qualitative and quantitative data on usability and (2) identify usability problems. A balanced gender-age sample of 10 individuals meeting the inclusion criteria was consecutively recruited online. The think-aloud testing method, the system usability scale, and an ad hoc semi-structured interview were employed to determine the overall system usability.

Read the detailed description

The study employed a mixed methods sequential explanatory design approach, comprising the following end-user testing: (1) a phase of collection and analysis of measures of performance employing the think-aloud method, (2) a phase of collection and analysis of quantitative data through the use of a System Usability Scale (SUS) and (3) a phase of collection and analysis of qualitative data through the use of an ad hoc semi-structured interview to further explain the results obtained in the earlier stages.

Ten individuals who showed interest in participating in the SOSteniamoci project by writing to the email address behind the official website (https://www.iterapi.se/sites/sosteniamoci/) were consecutively asked to take part in the usability test based on the inclusion criteria. A balanced gender-age sampling was used to best reflects the heterogeneity of the population.

As a result of the COVID-19 pandemic, all procedures were performed online (completion time: 45 mins, on average). First, each participant received an email with a) the link to the online meeting, including the date and time, and b) the link and access credentials of the SOSteniamoci platform. Before starting the usability test, the researcher provided detailed information about the test procedures and described the purpose of the computer-based self-management system. Participants were then asked to give their online informed consent, provide demographic information, and report on their level of comfort with computers and the Internet.

They were also asked if they had already taken a usability test before. All participants were assigned a unique ID unrelated to their identity. Personal data were linked only to this unique ID and stored in a secure online platform accessible only by the research team and protected by a password.

02

Conditions studied

  • Internet-based Intervention
03

In context

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Informal caregivers of a person with a chronic disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age >18 years
  • be able to read and speak the Italian language
  • have basic computer skills and Internet access
  • own a computer or a compatible device
  • having provided informed consent to participate.

Exclusion criteria

Exclusion criteria:

- presentation of self-reported visual, hearing, or cognitive impairments preventing the participant from following the instructions.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
10 participants (actual)
Patient registry
No

Interventions

  • OtherUsability testing

    Usability testing

06

What researchers measure

Primary outcomes

  1. Score of System Usability Scale (SUS)

    10-item scale with final score between 0 and 100

    Time frame: baseline

07

Study locations

1 site
  • Istituto Auxologico Italiano
    Milan, 20145, Italy
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References and documents

Individual participant data

Plan to share: No — There is not plan to make IPD available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05777915
Responsible party
Sponsor
First posted
Mar 21, 2023
Start date
Jan 15, 2022
Primary completion
Dec 15, 2022
Completion
Dec 15, 2022
Last update
Mar 21, 2023

Study contacts

Giada Pietrabissa, PhD
principal investigator · Istituto Auxologico Italiano

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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