Social Isolation, Loneliness (Descriptors Included in the MeSH) Clinical Trial
Official title:
Effectiveness of a Multi-component Non-pharmacological Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home
- 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.
-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.
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