- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05777915
SOSteniamoci: Usability Study
Preliminary Studies to the SOSteniamoci Project: Usability Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Milan, Italy, 20145
- Istituto Auxologico Italiano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of System Usability Scale (SUS)
Time Frame: baseline
|
10-item scale with final score between 0 and 100
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Giada Pietrabissa, PhD, Istituto Auxologico Italiano
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 03C211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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