NCT05777915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 9, 2023

Last Update Submit

March 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Score of System Usability Scale (SUS)

    10-item scale with final score between 0 and 100

    baseline

Interventions

Usability testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Informal caregivers of a person with a chronic disease

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20145, Italy

Location

MeSH Terms

Interventions

User-Centered Design

Intervention Hierarchy (Ancestors)

Equipment DesignInvestigative TechniquesUniversal DesignEngineeringTechnology, Industry, and Agriculture

Study Officials

  • Giada Pietrabissa, PhD

    Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

January 15, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

March 21, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

There is not plan to make IPD available.

Locations