Implementing the Transcultural Social-Ethical-Care Model -TEC-MED for Older People in the Mediterranean Basin (TEC-MED)

Implementation of the TEC-MED model of social and health care in the elderly population of the Mediterranean basin through a quasi-experimental trial. Participants will be assigned to the intervention group and will receive comprehensive care and assessment under the TEC-MED care model. Participants in the control group will receive usual care during the data collection phase, but will be offered care under the TEC-MED model at the end of the project.

Study Overview

• Status: Completed
• Conditions: Older People; Social Exclusion; Care Dependency
• Intervention / Treatment: Other: Socio-health care

• Study Type: Interventional
• Enrollment (Actual): 20000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41009
    • University of Seville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 60 years or more
• Living in the Mediterranean Basin countries

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTERVENTION GROUP; Implementation of socio-health care based on TEC-MED model	Other: Socio-health care; Socio-health care under TEC-MED model and an integral assessment; Other Names: TEC-MED care model
No Intervention: CONTROL GROUP; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Care Dependency Level	Assessment of the care dependency level using INICIARE Scale. The scale measures the care dependency level, framed in three levels: low level, mid level, high level. The expected outcome is to mantain the care dependency level, or low level, from the fisrt assessment to the second.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life level	Assessment of the quality of life level, using the EQ-5D-5L Scale. The scale measures the quality of life level, framed in two levels: low level and high level. The expected outcome is to improve the quality of live level, from the fisrt assessment to the second.	3 months

Collaborators and Investigators

• Sponsor: REGINA ALLANDE CUSSO
• Investigators: Study Director: Regina Allande-Cussó, Dr., University of Seville

Publications and helpful links

Helpful Links

• Webpage of the project

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: A_A 3 2_0376; TEC-MED (Other Identifier: University of Seville)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All personal data will be kept under confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No