Effectiveness of a Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home

Study Overview
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Brief Summary
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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.

Detailed Description
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-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.

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

Conditions
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Social Isolation, Loneliness (Descriptors Included in the MeSH)

Intervention / Treatment
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* Behavioral: non-pharmacological multicomponent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Non-pharmacological multicomponent intervention | Behavioral: non-pharmacological multicomponent<br>* Following the proposal of Nicholson & Shellman, (2013) collected in its CARELINK program, an intervention is proposed that includes: 6 sessions at home [30-60 minutes] for 16 weeks (1 fortnightly session) and 5 telephone sessions [20 min.] That will be intercalated (in the 16 weeks) depending on the particular characteristics of each person. The first visit, aimed at defining objectives and creating a relationship of trust for future visits.<br>|
| No Intervention: Control<br>Not intervention, usual attention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social isolation | 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. | 6 months | 
| loneliness | De Jong-Gierveld de Soledad Scale, which assesses individual subjective perception of social participation or isolation in the elderly population. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | Health Related Quality of Life (EuroQol-5D scale) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social isolation, Loneliness, Health Related Quality of Life