Clinical trial NCT05777915: SOSteniamoci: Usability Study
Official title: Preliminary Studies to the SOSteniamoci Project: Usability Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Internet-based Intervention
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Informal caregivers of a person with a chronic disease

Brief 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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Score of System Usability Scale (SUS)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
affiliation: Istituto Auxologico Italiano
name: Giada Pietrabissa, PhD
role: PRINCIPAL_INVESTIGATOR
References: