跳至主要内容
临床试验/NCT03345862
NCT03345862Unknown不适用

Effectiveness of a Multi-component Non-pharmacological Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home

Andaluz Health Service1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2018年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
114
试验地点
1
主要终点
Social isolation

研究概览

简要总结

  • Objectives: To evaluate the effectiveness, in terms of reducing social isolation and improving the Health Related Quality of Life (HRQOL), of a non-pharmacological multicomponent intervention in elderly telecare users.
  • Design: Clinical trial randomized by cluster, multicentric.
  • Location: 14 health centers of the Andalusian Health Service (Spain).
  • Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your home. Persons with cognitive impairment or dementia, difficulty in responding to scales, legal incapacitation or not giving consent will be excluded.

9 health centers will be randomly assigned to the intervention and control groups. The people of both groups will be evaluated at baseline, at 4 and at 6 months. 57 subjects will be included in each group (n = 114).

Variables: a) Independent: of the professional and of the patients (sociodemographic, healthcare, morbidity, intervention performed -multicomponent vs. non-intervention-) b) Dependents: social support, loneliness and HRQoL.

The intervention includes 8 sessions at home [1 hour], every 15 days and 4 telephone [30 minutes] -1 monthly-. To measure the effectiveness of the intervention, the Duke-UNC Functional Social Support Questionnaire (DUFSS), the De Jong-Gierveld Scale of loneliness, and the EuroQol-5D will be used to measure HRQoL.

Univariate, bivariate and multivariate statistical analysis (multiple linear regression).

-Aspects ethico-legal: Standards of good clinical practice and ethical principles of the Declaration of Helsinki. Informed consent. Application for authorization to the management of the Sanitary District.

详细描述

-Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your home. Telecare users. Persons with cognitive impairment or dementia, difficulty in responding to scales, legal incapacitation or not giving consent will be excluded.

9 health centers will be randomly assigned to the intervention and control groups. The people of both groups will be evaluated at baseline, at 4 and at 6 months. 57 subjects will be included in each group (n = 114).

Variables: a) Independent: of the professional and of the patients (sociodemographic, healthcare, morbidity, intervention performed -multicomponent vs. non-intervention-) b) Dependents: social support, loneliness and HRQoL.

The intervention includes 6 sessions at home [30-60 minutes], every 15 days and 5 telephone [20 minutes] -1 monthly-. To measure the effectiveness of the intervention, the Duke-UNC Functional Social Support Questionnaire (DUFSS), the De Jong-Gierveld Scale of loneliness, and the EuroQol-5D will be used to measure HRQoL. Analysis by intention to treat. Univariate, bivariate and multivariate statistical analysis (multiple linear regression).

-Aspects ethico-legal: Standards of good clinical practice and ethical principles of the Declaration of Helsinki. Informed consent. Application for authorization to the management of the Sanitary District. Approval of the Ethics and Clinical Research Committee.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • •Age 65 years or older.
  • •Residents in your home (not institutionalized).
  • •Present social isolation: score less than 32 (social support perceived low) with the Duke-UNC Functional Social Support Questionnaire (DUFSS).

排除标准

  • •Cognitive impairment (Mini-mental <22), or medical diagnosis of dementia.
  • •Difficulty responding to measurement scales due to language barriers.
  • •Legal incapacitation.
  • •Do not grant consent for participation in the study.

研究组 & 干预措施

Intervention

Experimental

Non-pharmacological multicomponent intervention

干预措施: non-pharmacological multicomponent (Behavioral)

Control

No Intervention

Not intervention, usual attention

结局指标

主要结局

Social isolation

时间窗: 6 months

Duke-UNC Functional Social Support Questionnaire (DUFSS), which reflects the opinion on the availability of other people to offer help in difficulties, skills in social relations and empathic and emotional communication.

loneliness

时间窗: 6 months

De Jong-Gierveld de Soledad Scale, which assesses individual subjective perception of social participation or isolation in the elderly population.

次要结局

  • Health Related Quality of Life(6 months)

研究者

发起方
Andaluz Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Luis Angel Perula de Torres

Dr. Ph.

Andaluz Health Service

研究点 (1)

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