The Ageing in a Networked Society -Social Experiment Study

NCT04242628 | Completed

• 1 other identifier: 2017-0946
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness; Social Isolation

Keywords

UCLA Version 3 scale; LSNS-6 scale

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Facebook course

EXPERIMENTAL

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.

Other: Facebook course

Lifestyle course

EXPERIMENTAL

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.

Other: Lifestyle Course

Waiting list

NO INTERVENTION

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).

Interventions

Facebook course OTHER

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

Facebook course

Lifestyle Course OTHER

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

Lifestyle course

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Fondazione Golgi Cenci: collaborator

Study Sites (1)

Fondazione Golgi Cenci

Abbiategrasso, Milano, Italy

Location

Related Publications (7)

• 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.

  PMID: 8576833 BACKGROUND

• 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.

  PMID: 8915764 BACKGROUND

• 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.

  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.

  PMID: 7836636 BACKGROUND

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

  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.

  PMID: 16921004 BACKGROUND

• 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.

  PMID: 33126634 DERIVED

Related Links

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

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Emanuela Sala, PhD

  Università degli Studi di Milano-Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: January 27, 2020
• Study Start: January 14, 2019
• Primary Completion: July 31, 2020
• Study Completion: September 30, 2020
• Last Updated: April 29, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available from November 2020 without a deadline
• Access Criteria: Data available upon written request by email to Fondazione Golgi Cenci (check the following URL)

Locations

IT (1)