Skip to main content
OpenTrials
Completed

NCT Number: NCT04242628

The Ageing in a Networked Society -Social Experiment Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Loneliness Behavior Social Behavior Social Isolation

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Golgi Cenci

Abbiategrasso, Milano, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facebook course

Other

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

Lifestyle Course

Other

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

Primary outcomes

  1. Subjective feeling of loneliness

    Time frame: Change from basline score at UCLA Loneliness Scale at 2 months

    Indicates self feeling of loneliness. Measured with UCLA Loneliness Scale Minimum score: 20; Maximum score: 80 Highest scores indicate greater loneliness (Russell, 1996).

  2. Stroop Test (inhibitory control and cognitive flexibility)

    Time frame: Change from basline score at test at 2 months

    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)

  3. Executive Cognitive functions: processing speed in Symbol Search

    Time frame: Change from basline score at test at 2 months

    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)

  4. Executive Cognitive functions: processing speed in Coding

    Time frame: Change from basline score at test at 2 months

    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)

  5. Executive Cognitive functions: working memory

    Time frame: Change from basline score at test at 2 months

    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)

  6. Executive Cognitive Functions - Trail Making Test (TMT)

    Time frame: Change from basline score at test at 2 months

    Executive Cognitive Functions measured through the Trail Making Test (TMT) (Giovagnoli et al., 1996)

  7. Cumulative Illness Rating Scale

    Time frame: Change from basline score at scale at 2 months

    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)

  8. Blood Pressure

    Time frame: Change from basline score for blood pressure at 2 months

    High blood pressure, measured in mmHg,can be an indicator of stress or other health problems

  9. 6 items Lubben Social Network Scale

    Time frame: Change from basline score at Lubben Social Network scale at 2 months

    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).

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Collaborators

  • Fondazione Golgi Cenci

Registry information

Official study title

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

Acronym: ANS-SE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.