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

• Sponsor: Maimónides Biomedical Research Institute of Córdoba (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04567940
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.1
• Patients Per Site Per Month: 12.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Social Isolation	Behavioral: ENRED@TE: Behavioural multicomponent intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: ENRED@TE. Social Support in Southern Spain. Interventional Study
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Feb 1, 2020
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control group Usual care

Outcome Measures

Primary Outcome Measures

1. Social isolation [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.

2. Loneliness [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.

Secondary Outcome Measures

1. Detection of risk situations or social problems [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimónides Biomedical Research Institute of Córdoba	Córdoba	Cordoba	Spain	14004

Sponsors and Collaborators

• Maimónides Biomedical Research Institute of Córdoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maimónides Biomedical Research Institute of Córdoba
• ClinicalTrials.gov Identifier: NCT04567940
• Other Study ID Numbers: ENRED@TE
• First Posted: Sep 29, 2020
• Last Update Posted: Oct 5, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maimónides Biomedical Research Institute of Córdoba: Social isolation; Social support; Loneliness; Family support

Study Results

No Results Posted as of Oct 5, 2020