Clinical trial NCT03345862: Effectiveness of a Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home
Official title: Effectiveness of a Multi-component Non-pharmacological Intervention to Reduce the Social Isolation and Loneliness of Elderly Residents at Home
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Isolation, Loneliness (Descriptors Included in the MeSH)
Keywords: Social isolation, Loneliness, Health Related Quality of Life
Lead sponsor: Andaluz Health Service
Sponsor class: OTHER_GOV
First posted: 2017-11-17
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Social isolation
timeFrame: 6 months
measure: loneliness
timeFrame: 6 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Luis Angel Perula de Torres
state: Andalucía
Study officials:
References: