Social Experiment on the Impact of Social Networking Sites (SNSs) Use on Older People's Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Executive Cognitive functions: working memory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Executive Cognitive functions: working memory
时间窗: 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)
Blood Pressure
时间窗: 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
Subjective feeling of loneliness
时间窗: 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).
Stroop Test (inhibitory control and cognitive flexibility)
时间窗: 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)
Executive Cognitive functions: processing speed in Symbol Search
时间窗: 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)
Executive Cognitive functions: processing speed in Coding
时间窗: 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)
Executive Cognitive Functions - Trail Making Test (TMT)
时间窗: Change from basline score at test at 2 months
Executive Cognitive Functions measured through the Trail Making Test (TMT) (Giovagnoli et al., 1996)
Cumulative Illness Rating Scale
时间窗: 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)
6 items Lubben Social Network Scale
时间窗: 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).
次要结局
未报告次要终点