Informal CaregiversNCT05797571
SOSteniamoci: Stakeholders' Survey
An observational study of Informal Caregivers, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informal Caregivers
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2022to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Formal and informal caregivers
Who may be able to join
- clinicians and informal caregivers
- aged 18 years or older
- internet access
- basic computer literacy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Informal Caregivers and Clinicians' Knowledge, Awareness, Attitude and Expect Barriers Towards Internet-based Interventions: A Stakeholders' Survey in Italy
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.
Read the detailed description
The present study assessed the knowledge and awareness, attitudes, willingness to participate in, and expected barriers towards using Internet-based interventions to alleviate caregivers' burden in a sample of Italian caregivers and clinicians. To this aim, an online stakeholders' survey was conducted in Italy among clinicians and informal caregivers, using a snowballing sampling technique. Participants were asked to fill in the informed consent and complete the online survey as a clinician, a caregiver, or both. Data were monitored daily. Descriptive statistics and Pearson correlation analysis were used for data analysis.
- Conditions
- Informal Caregivers
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score in Online survey for clinicians
Online survey for clinicians - 30 items
Measured: 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
Measured: At baseline, during online survey, performed after signing informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 Jan 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informal CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giada Pietrabissa, PhD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797571
- Sponsor's protocol ID
- 03C212
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informal Caregivers and Clinicians' Knowledge, Awareness, Attitude and Expect Barriers Towards Internet-based Interventions: A Stakeholders' Survey in Italy
- ClinicalTrials.gov ID
- NCT05797571
- Acronym / sponsor ID
- 03C212
- Conditions
- Informal Caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study assessed the knowledge and awareness, attitudes, willingness to participate in, and expected barriers towards using Internet-based interventions to alleviate caregivers' burden in a sample of Italian caregivers and clinicians. To this aim, an online stakeholders' survey was conducted in Italy among clinicians and informal caregivers, using a snowballing sampling technique. Participants were asked to fill in the informed consent and complete the online survey as a clinician, a caregiver, or both. Data were monitored daily. Descriptive statistics and Pearson correlation analysis were used for data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Formal and informal caregivers
Key inclusion criteria (4 listed)
- clinicians and informal caregivers
- aged 18 years or older
- internet access
- basic computer literacy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean score in Online survey for clinicians
Time frame: At baseline, during online survey, performed after signing informed consent
Online survey for clinicians - 30 items
Mean score in Online survey for informal caregivers
Time frame: At baseline, during online survey, performed after signing informed consent
Online survey for informal caregivers - 45 items
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giada Pietrabissa, PhD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Informal Caregivers, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score in Online survey for clinicians (time frame: At baseline, during online survey, performed after signing informed consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.