The Effect of Social Participation As a Key Determinant of Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline to post treatment and to follow-up of The Brief Social Rhythms Scale (Social and biological Rhythms)
研究概览
简要总结
The research aims to promote active aging through a pilot study. The design will be crossover with two groups. Intervention will consist of presentations and interactive debate sessions, with a central focus on intergenerational exchange covering cultural, historical, and health-related topics. A key aspect is the active involvement of beneficiaries, individuals over sixty-five. The outcomes will be quality of life, presence of depressive symptoms, and regularity of biological and social rhythms.
详细描述
In 2050, 36% of the Italian population will be over 65 years old. The European Union has identified as a priority the increase in research on active aging, promoting activities that can maintain and enhance the health and social engagement of individuals aged 65 and above.
This pilot study aims to assess feasibility a preliminary measure of effectiveness of a psychosocial intervention focused on intergenerational exchange on quality of life, biological and social rhythms, and mood in a group of elderly
The outcomes will include quality of life, presence of depressive symptoms, and regularity of biological and social rhythms, assessed before the intervention, immediately after intervention and at a follow-up four months after the intervention's conclusion.
The psychosocial intervention will consist of sessions on a weekly basis and delivered both in-person and remotely. The sessions will include presentations and interactive debate sessions, with a central focus on intergenerational exchange covering cultural, historical, and health-related topics. A key aspect is the active involvement of beneficiaries, individuals over sixty-five, who will be asked to prepare presentations with the support of project-provided facilitators. Simultaneously, the project will promote social inclusion, enhance skills, organizational capabilities, and computer literacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •people who are 65 years of age or older
排除标准
- •have serious problems with independent walking,
- •have serious neurological conditions or serious disabilities that make it impossible to participate in the intervention in person or remotely
结局指标
主要结局
Change from Baseline to post treatment and to follow-up of The Brief Social Rhythms Scale (Social and biological Rhythms)
时间窗: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
To evaluate it will be used: The Brief Social Rhythms Scale (BSRS), a 10 item questionnaire, values range from 10 to 60, designed to assess the level of regularity in biological and social rhythms, specifically those related to sleep-wake cycles and appetite, as well as social contacts. Higher scores recorded a worse regulation of rhythms
Intervention satisfaction at post intervention time
时间窗: at T1 (12 weeks)
Intervention satisfaction questionnaire (it will be considered a satisfactory level if on average the intervention is rated by the participants one standard deviation above the average of the ad hoc questionnaire)
Change from Baseline to post treatment and to follow-up of The Short Form Health Survey (Quality of life)
时间窗: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
To evaluate it will be used: The Short Form Health Survey (SF-12), a brief version of SF-36 questionnaire, made up of twelve questions, values range from 12 to 47, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health assessed on a monthly basis . Higher scores recorded a greeting and better Quality of life
Change from Baseline to post treatment and to follow-up of Patient Health Questionnaire-9 (Depression symptoms)
时间窗: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
To evaluate it will be used: Patient Health Questionnaire-9 (PHQ-9) a short self-administered tool, values range from 0 to 27, used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV on last two weeks. Higher scores identify a greater presence of depressive symptoms.
Change from Baseline to post treatment and to follow-up of Addenbrooke's Cognitive Examination (Cognitive performance)
时间窗: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
To evaluate it will be used: Addenbrooke's Cognitive Examination (ACE-R), a brief cognitive test, values range from 0 to 100, that assesses five cognitive areas: attention/orientation, memory, verbal fluency, language, and visuo-spatial abilities. The test incorporates the Mini Mental State Examination (MMSE). The higher the score obtained in the test, the lower the presence of signs that identify cognitive deterioration on the screening performance scales
Evaluation of the Feasibility of the intervention with Dropout rate at post intervention time
时间窗: at T1 (12 weeks)
To evaluate it will be used: Dropout rate (25% dropout in the sample will be considered acceptable considering that it is a group of elderly people)
Change from Baseline to post treatment and to follow-up of Physical Activity Questionnaire (type and quantity of physical activity)
时间窗: T0 (0 weeks); T1 (12 weeks); T2 (28 weeks)
To evaluate it will be used: Physical Activity Questionnaire (IPAQ) designed to measure the type and quantity of physical activity undertaken in the past 7 days, values range from 0 to the maximum amount of minutes a person spends on physical activity or sedentary activities, including occupational and recreational physical activities, through 9 items, on a weekly basis, Higher scores identify in a subscale a frequent physical activity (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
次要结局
未报告次要终点
研究者
Giulia Cossu
Principal Investigator
University of Cagliari