NCT05797571

Brief Summary

Informal care is defined as the unpaid care provided to an older, frail, or ill person, by a person such as a spouse, a parent, a child, another relative, a neighbor, or a friend. This phenomenon may lead to stress, burden, and decreased informal caregivers' quality of life. Since lack of time, distance from services, and financial strains make the provision of psychological interventions to informal caregivers often challenging, Internet-based (self-help) programs might represent a viable solution to promote their emotional well-being. Still, despite the proven benefits of internet-based intervention, no available programs for informal caregivers are available for the Italian population. Nevertheless, planning and developing an online intervention, involving possible stakeholders (caregivers), might facilitate the understanding and dissemination of, willingness to use, and success of the future intervention. Thus, the goal of the current study is to assess Italian stakeholders' knowledge about, awareness of, attitudes towards, willingness to participate and use, and expected barriers to internet-based interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 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 13, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 13, 2023

Last Update Submit

March 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mean score in Online survey for clinicians

    Online survey for clinicians - 30 items

    At baseline, during online survey, performed after signing informed consent

  • Mean score in Online survey for informal caregivers

    Online survey for informal caregivers - 45 items

    At baseline, during online survey, performed after signing informed consent

Eligibility Criteria

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

Formal and informal caregivers

You may qualify if:

  • clinicians and informal caregivers
  • aged 18 years or older
  • internet access
  • basic computer literacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giada Pietrabissa

Milan, 20145, Italy

Location

Study Officials

  • Giada Pietrabissa, PhD

    Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 13, 2023

First Posted

April 4, 2023

Study Start

January 15, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations