Well-Being, PsychologicalNCT06510959
Older People, New Needs, and Possible Solutions. A Pilot Study on Peer-to-peer Digital Education
A study testing Digital course in people with Well-Being, Psychological and Digital Skills, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
"Older people, new needs, and possible solutions: A pilot study on peer-to-peer digital education" aims to create a digital literacy protocol targeted specifically to older people, providing them with the digital skills needed to age healthily and actively in a changing social context. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological, Digital Skills
- What is being tested?
- Digital course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2024to 5 Jul 2024
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years old or older
- personal smartphone
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACTIVE Ageing in Changing Societies. Older People's Social and Digital Resources in Pandemic and Post-pandemic ITaly (ACTIVE-IT). Research Stream 3 - Older People, New Needs, and Possible Solutions. A Pilot Study on Peer-to-peer Digital Education
"Older people, new needs, and possible solutions: A pilot study on peer-to-peer digital education" aims to create a digital literacy protocol targeted specifically to older people, providing them with the digital skills needed to age healthily and actively in a changing social context. Specifically, the main goal is to pilot (by designing, implementing, and evaluating) a peer-to-peer digital literacy course, whereby older educators teach less digitally savvy older people how to use smartphone daily utility apps, such as e-Gov, home banking, etc.
To evaluate the effect of the intervention on participants, smartphone usage patterns are measured before, during, and after the course. Then, the impact of the course on participants' perception of well-being is assessed as well.
Read the detailed description
This study aims to pilot, by designing, implementing, and evaluating, a digital peer education course for older people, focusing specifically on the use of smartphones and daily utility apps. The course has been co-designed with AUSER MB, a non-profit organization involved in active aging, and the peer tutors. It is structured in ten 90-minute classes covering topics such as emails, online accounts, app downloads, e-Gov apps, healthcare apps, mobility and payment apps, etc. The 30 participants, divided into three groups, have been selected among the 65+ year-old people attending the computer classes already offered by AUSER MB and having a personal smartphone, as a very basic set of digital skills and familiarity with digital devices was necessary for the slightly more advanced topics covered by the course.
In addition to piloting the course and aiming to define a protocol that could be replicated in other similar contexts, this study aims to measure the effect of the course on participants' digital skills and their perceived well-being. To do so, the investigators adopted a mixed methods approach, employing digital methods by collecting and analyzing data on participants' smartphone use (i.e., log data on smartphone use before/during/after the intervention), a quasi-experiment collecting information on course participants' well-being before/after the course attendance using a questionnaire survey, and ethnographic observation conducted during the course, observing interactions between subjects during the course.
The study is part of the project "ACTIVE ageing in changing societies. Older people's social and digital resources in pandemic and post-pandemic Italy (ACTIVE-IT)", funded by the Italian Fondazione Cariplo
- Conditions
- Well-Being, Psychological, Digital Skills
- Being tested
- Digital course
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital courseOther
The course aims to enhance participants' digital skills concerning the use of smartphones, specifically focusing on daily utility apps such as email apps, eGov apps, mobility apps, etc. The course is structured into the following ten 90-minute weekly lessons.
| Study group | Role | What they receive |
|---|---|---|
| Digital course | Other | 10-lesson weekly course taught by a peer on the use of smartphones and daily utility apps. Receives: Other: Digital course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smartphone usage patterns
To evaluate changes in smartphone usage patterns, the investigators collect smartphone usage data for about four months: (one month) before the start of the course, during the course attendance, and (one month) after the course has ended through the app Stay Free - Screen Time. This app collects the categories of the apps that participants used during the monitoring period, the exact time (day, hour, minutes) the apps started/stopped to be used, and the duration (in seconds) of use of each apps' category. The category of the apps and the duration of use, as well as the day in which they have been used, will be combined to study participants' using habits.
Measured: Four months (feb 24 - jun 24)
Perception of wellbeing
To evaluate the impact of the peer-to-peer digital education course on participants' wellbeing, the investigators will adopt a quasi-experiment approach, inviting course participants to fill in a short online self-completed questionnaire during the first and last class of the course. The investigators will collect the following five types of measures: current use of and competence on digital device use, attitudes towards technology, life satisfaction, happiness and wellbeing, demographic and socio-economic characteristics, health status.
Measured: Two measurements: baseline, pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start8 Feb 2024
- Primary completion6 Jun 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia, University of Applied Sciences and Arts of Southern Switzerland, Catholic University, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510959
- Sponsor's protocol ID
- 2021-0897
- Status last verified
- Jul 2024
- First submitted
- 5 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised qualitative and quantitative data will be deposited within the UniData Bicocca Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIVE Ageing in Changing Societies. Older People's Social and Digital Resources in Pandemic and Post-pandemic ITaly (ACTIVE-IT). Research Stream 3 - Older People, New Needs, and Possible Solutions. A Pilot Study on Peer-to-peer Digital Education
- ClinicalTrials.gov ID
- NCT06510959
- Acronym / sponsor ID
- 2021-0897
- Conditions
- Well-Being, Psychological, Digital Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- University of Pavia, University of Applied Sciences and Arts of Southern Switzerland, Catholic University, Italy
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 19 Jul 2024 (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.
"Older people, new needs, and possible solutions: A pilot study on peer-to-peer digital education" aims to create a digital literacy protocol targeted specifically to older people, providing them with the digital skills needed to age healthily and actively in a changing social context. Specifically, the main goal is to pilot (by designing, implementing, and evaluating) a peer-to-peer digital literacy course, whereby older educators teach less digitally savvy older people how to use smartphone daily utility apps, such as e-Gov, home banking, etc.
To evaluate the effect of the intervention on participants, smartphone usage patterns are measured before, during, and after the course. Then, the impact of the course on participants' perception of well-being is assessed as well.
Detailed description
This study aims to pilot, by designing, implementing, and evaluating, a digital peer education course for older people, focusing specifically on the use of smartphones and daily utility apps. The course has been co-designed with AUSER MB, a non-profit organization involved in active aging, and the peer tutors. It is structured in ten 90-minute classes covering topics such as emails, online accounts, app downloads, e-Gov apps, healthcare apps, mobility and payment apps, etc. The 30 participants, divided into three groups, have been selected among the 65+ year-old people attending the computer classes already offered by AUSER MB and having a personal smartphone, as a very basic set of digital skills and familiarity with digital devices was necessary for the slightly more advanced topics covered by the course.
In addition to piloting the course and aiming to define a protocol that could be replicated in other similar contexts, this study aims to measure the effect of the course on participants' digital skills and their perceived well-being. To do so, the investigators adopted a mixed methods approach, employing digital methods by collecting and analyzing data on participants' smartphone use (i.e., log data on smartphone use before/during/after the intervention), a quasi-experiment collecting information on course participants' well-being before/after the course attendance using a questionnaire survey, and ethnographic observation conducted during the course, observing interactions between subjects during the course.
The study is part of the project "ACTIVE ageing in changing societies. Older people's social and digital resources in pandemic and post-pandemic Italy (ACTIVE-IT)", funded by the Italian Fondazione Cariplo
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital course | Other | Other: Digital course10-lesson weekly course taught by a peer on the use of smartphones and daily utility apps. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years old or older
- personal smartphone
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital courseThe course aims to enhance participants' digital skills concerning the use of smartphones, specifically focusing on daily utility apps such as email apps, eGov apps, mobility apps, etc. The course is structured into the following ten 90-minute weekly lessons. | Other | Digital course |
Primary outcome
Smartphone usage patterns
Time frame: Four months (feb 24 - jun 24)
To evaluate changes in smartphone usage patterns, the investigators collect smartphone usage data for about four months: (one month) before the start of the course, during the course attendance, and (one month) after the course has ended through the app Stay Free - Screen Time. This app collects the categories of the apps that participants used during the monitoring period, the exact time (day, hour, minutes) the apps started/stopped to be used, and the duration (in seconds) of use of each apps' category. The category of the apps and the duration of use, as well as the day in which they have been used, will be combined to study participants' using habits.
Perception of wellbeing
Time frame: Two measurements: baseline, pre-intervention and immediately after the intervention
To evaluate the impact of the peer-to-peer digital education course on participants' wellbeing, the investigators will adopt a quasi-experiment approach, inviting course participants to fill in a short online self-completed questionnaire during the first and last class of the course. The investigators will collect the following five types of measures: current use of and competence on digital device use, attitudes towards technology, life satisfaction, happiness and wellbeing, demographic and socio-economic characteristics, health status.
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 19 Jul 2024.
- Website of the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised qualitative and quantitative data will be deposited within the UniData Bicocca Data Archive.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital course in people with Well-Being, Psychological and Digital Skills, run by University of Milano Bicocca 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 2 inclusion and 1 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 19 Jul 2024. 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?
Smartphone usage patterns (time frame: Four months (feb 24 - jun 24)). 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 19 Jul 2024.