NCT03345862

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Andaluz Health Service · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

* 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

-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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	non-pharmacological multicomponent	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.

Timeline

• Start date: 2018-05-15
• Primary completion: 2020-04-01
• Completion: 2020-08-01
• First posted: 2017-11-17
• Last updated: 2020-07-14

Locations

1 site across 1 country: Spain