Effectiveness of a multicomponent intervention to reduce social isolation and loneliness in community-dwelling elders: A randomized clinical trial. Study protocol

This study aims to evaluate the effectiveness of a multicomponent intervention in non-institutionalized older people. This effectiveness will be assessed in terms of reducing social isolation and loneliness and improving Health-Related Quality of Life.The concern for social isolation and loneliness in non-institutionalized older adults has increased in recent decades. In addition, their relationship with numerous negative health outcomes is amply demonstrated.A mixed-method design including a cluster randomized controlled clinical trial and an exploratory qualitative study with focus groups was used.Each study group consists of 57 subjects. The experimental group will be subjected to a multicomponent intervention comprising six domiciliary face-to-face sessions and five telephone calls that will be interspersed. Interventions will be conducted by healthcare professionals and volunteers. The control group will not be subjected to any systematized intervention. We are going to consider social isolation, loneliness, and Quality of Life as the primary outcomes. However, the factors that influence both primary outcomes and the feasibility of the intervention in clinical practice will also be assessed.Despite the negative influence of social isolation and loneliness on clinical outcomes is widely evidenced, few early detection programs are available, especially interventions at the community setting. This study will examine the effectiveness of the intervention in the Spanish community setting. At the same time, this study will identify the feasibility of this intervention in Primary Care clinical practice.Substantial evidence indicates the detrimental health impact of social isolation and loneliness, particularly on mental wellness. Knowing that mental disorders are associated with high economic cost, this project would have strong clinical implication to inform nursing practice on managing social isolation and loneliness. The findings may also inform primary health policy setting in Spain and the wider European countries.目的: 本研究旨在评估对不是住在福利院的老年人进行多因素干预的有效性。将从减少社会孤立和孤独感以及提高与健康相关的生活质量的角度对有效性进行评估。 背景: 近几十年来,对不是住在福利院的老年人被社会孤立和孤独感的担忧有所增加。此外,它们也被充分证明与许多负面健康结果有关。 设计: 采用包括分组随机对照临床试验和针对重点人群的探索性定性研究在内的混合方法设计。 方法: 每个研究小组由57名试验对象组成。实验小组将接受多因素干预,包括六次面对面的家庭谈话,并插入五次电话谈话。干预将由专业医疗人员以及志愿者进行。对照组将不接受任何系统化干预。我们将把社会孤立、孤独感以及生活质量视为主要结果,但还会评估影响主要结果的因素和临床实践干预的可行性。 讨论: 尽管社会孤立和孤独感对临床结果的负面影响已被广泛证实,却很少有可用的早期探测项目,尤其是在社区中的干预措施。本研究将考察干预措施在西班牙人居住社区中的有效性。与此同时,本研究将确定此干预措施在初级保健临床实践中的可行性。 影响: 大量证据表明,被社会孤立以及孤独感对健康有害,尤其是对精神健康。由于精神障碍与高经济成本相关,本研究课题在为护理实践提供管理社会孤立及孤独感上有着极大的临床意义。调查结果还可能为西班牙乃至更多的欧洲国家基本卫生政策的制定提供参考。.