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

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: Social Isolation
• Intervention / Treatment: Behavioral: ENRED@TE: Behavioural multicomponent intervention

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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

• Sponsor: Maimónides Biomedical Research Institute of Córdoba

Study record dates

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: Loneliness; Social support; Social isolation; Family support
• 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