The Ageing in a Networked Society -Social Experiment Study

Loneliness Clinical Trial

— ANS-SE  

Official title:

Social Experiment on the Impact of Social Networking Sites (SNSs) Use on Older People's Wellbeing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242628
• Other study ID #: 2017-0946
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2021
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Loneliness
• Social Isolation

Intervention

Other:
• Facebook course
The intervention consists of the attendance to a course on Facebook and Social Networking Sites use
• Lifestyle Course
The intervention consists of the attendance to a course on lifestyle education and brain functioning in older people

Locations

Country	Name	City	State
Italy	Fondazione Golgi Cenci	Abbiategrasso	Milano

Sponsors (2)

Lead Sponsor	Collaborator
University of Milano Bicocca	Fondazione Golgi Cenci

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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.

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. — View 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. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective feeling of loneliness	Indicates self feeling of loneliness. Measured with UCLA Loneliness Scale Minimum score: 20; Maximum score: 80 Highest scores indicate greater loneliness (Russell, 1996).	Change from basline score at UCLA Loneliness Scale at 2 months
Primary	Stroop Test (inhibitory control and cognitive flexibility)	Executive Cognitive Functions measured through the Stroop Test Interference score for time and errors (higher scores worse performance) Score range: n.a. (Cafarra et al., 2002)	Change from basline score at test at 2 months
Primary	Executive Cognitive functions: processing speed in Symbol Search	Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV).; Symbol Search, score range 0-60 Higher scores better performances (Orsini & Pezzuti, 2013)	Change from basline score at test at 2 months
Primary	Executive Cognitive functions: processing speed in Coding	Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV).; Coding: score range 0-135 Higher scores better performances (Orsini & Pezzuti, 2013)	Change from basline score at test at 2 months
Primary	Executive Cognitive functions: working memory	Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV).; Digit Span: score range 0-48 Higher scores better performances (Orsini & Pezzuti, 2013)	Change from basline score at test at 2 months
Primary	Executive Cognitive Functions - Trail Making Test (TMT)	Executive Cognitive Functions measured through the Trail Making Test (TMT) (Giovagnoli et al., 1996)	Change from basline score at test at 2 months
Primary	Cumulative Illness Rating Scale	Clinical tool to measure objective older people illness status Scores range between 14 to 70 with a higher score indicating worse health satus (Parmelee et al. 1995)	Change from basline score at scale at 2 months
Primary	Blood Pressure	High blood pressure, measured in mmHg,can be an indicator of stress or other health problems	Change from basline score for blood pressure at 2 months
Primary	6 items Lubben Social Network Scale	This scale is a self-report measure of social engagement including family and friends. The score ranges between 0 and 30, with a higher score indicating more social engagement. (Lubben et al. 2006).	Change from basline score at Lubben Social Network scale at 2 months

External Links

•   Brain ageing in Abbiategrasso study
•   Ethical Committee (Università Bicocca)
•   Fondazione Cariplo
•   Fondazione Golgi Cenci
•   PI's University page