The Ageing in a Networked Society -Social Experiment Study

NCT ID: NCT04242628

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-09-30

Brief Summary

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The Ageing in a Networked Society -Social Experiment study (ANS-SE) is a randomised controlled trial on older people residing in Abbiategrasso, a middle-size city located in the Milan area (Italy) and aims to assess the impact of SNS use on loneliness, that is the primary outcome of this study. The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into two treatment groups and a control group; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (T2). The control group (C) is constituted of a waiting list. The study is part of the project "Aging in a networked society. Older people, social networks and well-being", funded by the Italian Fondazione Cariplo.

Detailed Description

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The objective of the study is to evaluate the short-term and long-term impact of Facebook use on physical and mental health of older people. The experiment is carried out on 180 participants of the Brain Aging in Abbiategrasso Study (InveCe).The InveCE study is a biannual cohort study of older people born between 1935 and 1939 and living in Abbiategrasso, a town near Milan, in northern Italy (NCT01345110, ClinicalTrials.gov). For more information, see http://www.golgicenci.it/en/studio-invece/.

Participants are selected among those who agreed to take part in the 4th wave of the InveCe.Ab study. Inclusion and exclusion criteria are specified in the Eligibility box below. The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into two treatment groups and a control group; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (T2). The control group (C) is constituted of a waiting list. Participant are assigned to one of these three groups randomly. Before/after the intervention, researchers administered a questionaire to participants to measure levels of loneliness, depression and neuropsychological functioning (see the box "Outcome Measure" for the description of the scales and measures used), together with a medical examination. The same assessment will be performed after one year. Data collected will be analyzed using statistical techniques in order to evaluate the impact of Facebook use on well-being.

The study is part of the project "Aging in a networked society. Older people, social networks and well-being", funded by the Italian Fondazione Cariplo.

Conditions

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Loneliness Social Isolation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention consists of the attendance to two training courses. T1 study members attended a three week course (two classes per week) on smartphones and SNS use. T2 study members attended 5 interactive 90-min meetings on lifestyle education and brain functioning in older people. A goodbye tea was offered after T2 meetings. Throughout the duration of the intervention, we put C study members on a waiting list; at the end of the intervention, in June 2019, interested group C study members attended the SNSs course (held on June 2019). One year after the first intervention, i.e. in March 2020, we will carry out a follow up assessment on T1 and T2 participants. Note that, due to the constraints imposed by the ethical committee (i.e. we offered members of the C group the possibility to attend the SNS course during the first intervention), the members of the C group are excluded from the follow up.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Facebook course

T1 study members attended a three week course (two classes per week) on smartphones and SNS use. Specifically, the course covers the following topics: smartphone use; Facebook use; WhatsApp use, privacy rules and fraud risk prevention using Facebook. Throughout the duration of the intervention, a tutor was available every Tuesday and Thursday to assist T1 participants in using SNSs.

Group Type EXPERIMENTAL

Facebook course

Intervention Type OTHER

The intervention consists of the attendance to a course on Facebook and Social Networking Sites use

Lifestyle course

T2 study members attended 5 interactive 90-min meetings on lifestyle education and brain functioning in older people. These meetings covered the following topics regarding good habits for wellbeing at older age: nutrition, brain ageing, physical activity, leisure activities, resources of the city for older people. A goodbye tea was offered after the meetings.

Group Type EXPERIMENTAL

Lifestyle Course

Intervention Type OTHER

The intervention consists of the attendance to a course on lifestyle education and brain functioning in older people

Waiting list

Throughout the duration of the intervention, we put C study members on a waiting list; at the end of the intervention, in June 2019, interested group C study members attended the SNSs course (held on June 2019).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Facebook course

The intervention consists of the attendance to a course on Facebook and Social Networking Sites use

Intervention Type OTHER

Lifestyle Course

The intervention consists of the attendance to a course on lifestyle education and brain functioning in older people

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants to the third follow-up of the Brain Ageing in Abbiategrasso Study (InveCe.Ab study)
* Good mental health
* No physical limitations
* Good cognitive health
* No experience in using Social Networks SItes (SNSs)

Exclusion Criteria

* GDS (Geriatric Depression Score) score equal to or greater than 10 (no major depression)
* Hands functional limitations
* Visual or hearing impairment
* Dementia or Mild Cognitive Impairment (MCI),
* Mini-Mental State Examination (MMSE) lower than 24
* Used SNS at least one time in life
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Golgi Cenci

OTHER

Sponsor Role collaborator

University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emanuela Sala, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Milano-Bicocca

Locations

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Fondazione Golgi Cenci

Abbiategrasso, Milano, Italy

Site Status

Countries

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Italy

References

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Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.

Reference Type BACKGROUND
PMID: 8576833 (View on PubMed)

Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E. Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci. 1996 Aug;17(4):305-9. doi: 10.1007/BF01997792.

Reference Type BACKGROUND
PMID: 8915764 (View on PubMed)

Caffarra P., Vezzadini G., Dieci F., Zonato A., Venneri A., Una versione abbreviata del test di stroop: dati normativi nella popolazione italiana. Nuova Rivista di Neurologia 2002, 12 (14): 111-115.

Reference Type BACKGROUND

Parmelee PA, Thuras PD, Katz IR, Lawton MP. Validation of the Cumulative Illness Rating Scale in a geriatric residential population. J Am Geriatr Soc. 1995 Feb;43(2):130-7. doi: 10.1111/j.1532-5415.1995.tb06377.x.

Reference Type BACKGROUND
PMID: 7836636 (View on PubMed)

Orsini A., Pezzuti L.(2013). WAIS-IV. Contributo alla taratura italiana.Giunti OS. Firenze.

Reference Type BACKGROUND

Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503.

Reference Type BACKGROUND
PMID: 16921004 (View on PubMed)

Rolandi E, Vaccaro R, Abbondanza S, Casanova G, Pettinato L, Colombo M, Guaita A. Loneliness and Social Engagement in Older Adults Based in Lombardy during the COVID-19 Lockdown: The Long-Term Effects of a Course on Social Networking Sites Use. Int J Environ Res Public Health. 2020 Oct 28;17(21):7912. doi: 10.3390/ijerph17217912.

Reference Type DERIVED
PMID: 33126634 (View on PubMed)

Related Links

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Other Identifiers

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2017-0946

Identifier Type: -

Identifier Source: org_study_id

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