NCT04567940

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

September 23, 2020

Last Update Submit

October 11, 2022

Conditions

Social Isolation

Keywords

Social isolationSocial supportLonelinessFamily support

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Detection of risk situations or social problems

    6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioural multicomponent intervention

Behavioral: ENRED@TE: Behavioural multicomponent intervention

Control group

NO INTERVENTION

Usual care

Interventions

ENRED@TE: Behavioural multicomponent interventionBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • People over 65 years
  • Not institutionalised

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimónides Biomedical Research Institute of Córdoba

Córdoba, Cordoba, 14004, Spain

Location

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 29, 2020

Study Start

September 1, 2019

Primary Completion

February 1, 2020

Study Completion

June 1, 2021

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)