Clinical trial NCT04242628: The Ageing in a Networked Society -Social Experiment Study
Official title: Social Experiment on the Impact of Social Networking Sites (SNSs) Use on Older People's Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Social Isolation
Keywords: UCLA Version 3 scale
LSNS-6 scale
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Fondazione Golgi Cenci
First posted: 2020-01-27
Enrollment: 180
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective feeling of loneliness
timeFrame: Change from basline score at UCLA Loneliness Scale at 2 months
measure: Stroop Test (inhibitory control and cognitive flexibility)
timeFrame: Change from basline score at test at 2 months
measure: Executive Cognitive functions: processing speed in Symbol Search
timeFrame: Change from basline score at test at 2 months
measure: Executive Cognitive functions: processing speed in Coding
timeFrame: Change from basline score at test at 2 months
measure: Executive Cognitive functions: working memory
timeFrame: Change from basline score at test at 2 months
measure: Executive Cognitive Functions - Trail Making Test (TMT)
timeFrame: Change from basline score at test at 2 months
measure: Cumulative Illness Rating Scale
timeFrame: Change from basline score at scale at 2 months
measure: Blood Pressure
timeFrame: Change from basline score for blood pressure at 2 months
measure: 6 items Lubben Social Network Scale
timeFrame: Change from basline score at Lubben Social Network scale at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abbiategrasso
country: Italy
facility: Fondazione Golgi Cenci
state: Milano
Study officials:
affiliation: Università degli Studi di Milano-Bicocca
name: Emanuela Sala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Orsini A., Pezzuti L.(2013). WAIS-IV. Contributo alla taratura italiana.Giunti OS. Firenze.
citation: 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.
citation: 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.