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

NCT03345862 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-07-14

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Andaluz Health Service

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2020-04-01
Completion
2020-08-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345862 on ClinicalTrials.gov