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

Andaluz Health Service

Status: Unknown

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

Treatments: Behavioral: non-pharmacological multicomponent

Study type: Interventional

Funder types: Other

Identifiers

NCT03345862

AP-0079-2016

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Intervention

Experimental group

Description:

Non-pharmacological multicomponent intervention

Treatment:

Behavioral: non-pharmacological multicomponent

Control

No Intervention group

Description:

Not intervention, usual attention