- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242628
The Ageing in a Networked Society -Social Experiment Study (ANS-SE)
Social Experiment on the Impact of Social Networking Sites (SNSs) Use on Older People's Wellbeing
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Milano
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Abbiategrasso, Milano, Italy
- Fondazione Golgi Cenci
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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).
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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).
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Change from basline score at UCLA Loneliness Scale at 2 months
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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)
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Change from basline score at test at 2 months
|
Cumulative Illness Rating Scale
Time Frame: Change from basline score at scale at 2 months
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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)
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Change from basline score at scale at 2 months
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Blood Pressure
Time Frame: Change from basline score for blood pressure at 2 months
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High blood pressure, measured in mmHg,can be an indicator of stress or other health problems
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Change from basline score for blood pressure at 2 months
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6 items Lubben Social Network Scale
Time Frame: Change from basline score at Lubben Social Network scale at 2 months
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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).
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Change from basline score at Lubben Social Network scale at 2 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emanuela Sala, PhD, Università degli Studi di Milano-Bicocca
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Orsini A., Pezzuti L.(2013). WAIS-IV. Contributo alla taratura italiana.Giunti OS. Firenze.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017-0946
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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