ENRED@TE. Social Support in Southern Spain. Interventional Study

October 11, 2022 updated by: Maimónides Biomedical Research Institute of Córdoba
The main objective to be achieved is to find out if the perceived social support, the perceived loneliness, the perceived social isolation and the family support of those over 65 years of age improve after participating in the Enréd@te project carried out by the Spanish Red Cross (CRE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Maimónides Biomedical Research Institute of Córdoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People over 65 years
  • Not institutionalised

Exclusion Criteria:

  • Participants of other programs
  • Difficulty responding to measurement scales due to language barriers
  • Legal incapacitation
  • People with a residence of less than 3 months in the city

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Usual care
EXPERIMENTAL: Intervention group
Behavioural multicomponent intervention
Behavioral: ENRED@TE: Behavioural multicomponent intervention
Information and awareness activities; activities for the acquisition of skills; activities that help the elderly to attend spaces for leisure, participation and maintenance and/or improvement of their personal relationships.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social isolation
Time Frame: 6 months
Duke-UNC Functional Social Support Questionnaire (Bellón et al. 1996) is an eight-item instrument to measure the strength of the person's social support network. Each item is ranged from 1 to 5 points, where high scores represent greater social support.
6 months
Loneliness
Time Frame: 6 months
UCLA Loneliness Scale (Russell DW, 1996) which is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. This tool use a 4-point rating scale (1= never; 4 = always). High values mean more loneliness.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of risk situations or social problems
Time Frame: 6 months
Gijón socio-family assessment scale (García González et al. 1999) allows the detection of risk situations or social problems. Values range from 3 to 15. Higher values mean more severe social decline.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

June 1, 2021

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (ACTUAL)

September 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ENRED@TE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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