Older PeopleTEC-MEDNCT06184178
Implementing the Transcultural Social-Ethical-Care Model -TEC-MED for Older People in the Mediterranean Basin
A study testing Socio-health care in people with Older People and Care Dependency, run by REGINA ALLANDE CUSSO at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older People, Care Dependency, Social Exclusion
- What is being tested?
- Socio-health care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years or more
- Living in the Mediterranean Basin countries
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Older People, Care Dependency, Social Exclusion
- Being tested
- Socio-health care
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socio-health careOther
Also called TEC-MED care model
Socio-health care under TEC-MED model and an integral assessment
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP | Experimental | Implementation of socio-health care based on TEC-MED model Receives: Other: Socio-health care |
| CONTROL GROUP | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- REGINA ALLANDE CUSSO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, REGINA ALLANDE CUSSO, University of Seville
- Investigators
- Regina Allande-Cussó, Dr., Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184178
- Sponsor's protocol ID
- A_A 3 2_0376
- Other IDs
- TEC-MED
- Acronym
- TEC-MED
- Status last verified
- May 2024
- First submitted
- 5 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personal data will be kept under confidentiality
Publications
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.
PubMed 40352956
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the Transcultural Social-Ethical-Care Model -TEC-MED for Older People in the Mediterranean Basin
- ClinicalTrials.gov ID
- NCT06184178
- Acronym / sponsor ID
- TEC-MED / A_A 3 2_0376
- Conditions
- Older People, Care Dependency, Social Exclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- REGINA ALLANDE CUSSOUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Experimental | Other: Socio-health careImplementation of socio-health care based on TEC-MED model |
| CONTROL GROUP | No intervention | –No intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 years or more
- Living in the Mediterranean Basin countries
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socio-health careAlso: TEC-MED care modelSocio-health care under TEC-MED model and an integral assessment | Other | INTERVENTION GROUP |
Primary outcome
Care Dependency Level
Time frame: 3 months
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.
1 secondary outcome
Quality of life level
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 40352956Lima-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.
- Webpage of the projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. All personal data will be kept under confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Allande-Cussó, Dr. study director
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socio-health care in people with Older People and Care Dependency, run by REGINA ALLANDE CUSSO at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Dependency Level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.