The Ageing in a Networked Society -Social Experiment Study (ANS-SE)

April 28, 2022 updated by: University of Milano Bicocca

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

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Milano
      • Abbiategrasso, Milano, Italy
        • Fondazione Golgi Cenci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
The intervention consists of the attendance to a course on Facebook and Social Networking Sites use
Experimental: 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.
The intervention consists of the attendance to a course on lifestyle education and brain functioning in older people
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from basline score at UCLA Loneliness Scale at 2 months
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)
Change from basline score at test at 2 months
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)

Change from basline score at test at 2 months
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)

Change from basline score at test at 2 months
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)

Change from basline score at test at 2 months
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)
Change from basline score at test at 2 months
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)
Change from basline score at scale at 2 months
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
Change from basline score for blood pressure at 2 months
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).
Change from basline score at Lubben Social Network scale at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Emanuela Sala, PhD, Università degli Studi di Milano-Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-0946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon request by email to Fondazione Golgi Cenci. Applicants will receive a form to fill with all the information about the research design and purpose. The application will be evaluated by a comittee chaired by Prof. Emanuela Sala. The final decision will be communicated within two weeks.

IPD Sharing Time Frame

Data will be available from November 2020 without a deadline

IPD Sharing Access Criteria

Data available upon written request by email to Fondazione Golgi Cenci (check the following URL)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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