The Ageing in a Networked Society -Social Experiment Study

Study Overview
=================
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.

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

Conditions
-----------------
Loneliness, Social Isolation

Intervention / Treatment
-----------------
* Other: Facebook course
* Other: Lifestyle Course


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facebook course<br>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<br>* The intervention consists of the attendance to a course on Facebook and Social Networking Sites use<br>|
| Experimental: Lifestyle course<br>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<br>* The intervention consists of the attendance to a course on lifestyle education and brain functioning in older people<br>|
| No Intervention: Waiting list<br>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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UCLA Version 3 scale, LSNS-6 scale