NCT06184178

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

December 5, 2023

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of life level

    3 months

Study Arms (2)

INTERVENTION GROUP

EXPERIMENTAL

Implementation of socio-health care based on TEC-MED model

Other: Socio-health care

CONTROL GROUP

NO INTERVENTION

No intervention

Interventions

Socio-health care under TEC-MED model and an integral assessment

Also known as: TEC-MED care model
INTERVENTION GROUP

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or more
  • Living in the Mediterranean Basin countries

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Seville

Seville, 41009, Spain

Location

Related Publications (1)

  • Lima-Serrano M, Allande-Cusso R, Vargas-Martinez AM, Karam G, El-Korh L, Porcel-Galvez AM. Testing the TEC-MED-Integrated Transcultural Social-Ethical-Care Model for Older People in the Mediterranean Basin: A Mixed-Method Quasiexperimental Study Protocol. Int J Integr Care. 2025 May 9;25(2):9. doi: 10.5334/ijic.9017. eCollection 2025 Apr-Jun.

Related Links

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Regina Allande-Cussó, Dr.

    University of Seville

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 28, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 31, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

All personal data will be kept under confidentiality

Locations