Geriatric AssessmentVALLUBNCT06909591
Transcultural and Psychometric Validation of the Lubben Social Network Scale in Older Adults Living in the French West Indies
An observational study of Geriatric Assessment and Patients Over 65 Years Old, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
Social isolation and loneliness are common among older adults. They are associated with high morbidity and mortality, with an impact comparable to that of other known risk factors such as obesity, a sedentary lifestyle, smoking, etc. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Assessment, Patients Over 65 Years Old
- What is being tested?
- Self-assessment questionnaire
- How many people
- 150 participants
- Where
- 1 siteMartinique
- Study dates
- 1 Sep 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged of 65 or older
Who may be able to join
- Patient ≥ 65 years old,
- Hospitalized (Geriatric Day Hospital (HDJ) or Geriatric Medical Care and Rehabilitation Service (SMT)), or seen in geriatric external consultation,
- MMS ≥ 20,
- Patient able to understand and answer a self-administered questionnaire in French,
- Patient having been informed of the research,
- Patient agreeing to participate in the study.
Who cannot join
- Patient with sensory disorders preventing completion of the questionnaire,
- Patient unable to consent to participate in the study,
- Patient under legal protection, guardianship, or curatorship,
- Patient who has refused to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martinique1 site
CHU of Martinique
Fort-de-France, 97261
Nadine SIMO TABUE, MD, 05 96 48 81 95 ext. +596, nadine.tabueteguo@chu-martinique.fr
Nadine SIMO TABUE, MD
About this study
Social isolation and loneliness are common among older adults. They are associated with high morbidity and mortality, with an impact comparable to that of other known risk factors such as obesity, a sedentary lifestyle, smoking, etc.
To date, there is no tool to measure social isolation and loneliness for patients living in the French West Indies. Applying unadapted and unvalidated tools to them without taking into account local ethnocultural realities would be risky.
Read more
The investigators believe it is necessary to adapt the scales used to measure social isolation and loneliness for a population living in the French West Indies.
Through this study, the investigators propose adapting the Lubben Social Network Scale, a social isolation questionnaire, for this population and conducting its psychometric validation.
Read the detailed description
Social isolation and loneliness are common among older adults. They are associated with high morbidity and mortality, with an impact comparable to that of other known risk factors such as obesity, a sedentary lifestyle, smoking, etc.
Loneliness is a subjective concept of social relationships, most often reflecting a negative feeling.
Social isolation, on the other hand, is an objective concept of social relationships and refers to infrequent or rare contact with family and friends and can also include living alone.
The feeling of loneliness is linked to social isolation, although the association is only partial.
Indeed, some socially isolated people do not always experience loneliness; and some people living alone are not always socially isolated.
Two theories of loneliness argue that a mismatch between expectations and realities of social contact (cognitive theory) and a lack of intimate or social relationships (deficit theory) can lead to feelings of social or emotional loneliness.
A meta-analysis showed that the risk of premature death was 26% higher in people experiencing loneliness, 29% higher in those who were socially isolated, and 32% higher in the group living alone.
Another meta-analysis examined the effects of loneliness and social isolation on (among other things) mortality. The results showed that loneliness and social isolation were significantly associated with an increased risk of mortality.
The authors conclude that further research is needed to confirm whether loneliness and social isolation have a direct impact on mortality, or whether the association is indirect via the cardiovascular system and psychological health.
To date, there is no tool to measure social isolation and loneliness for patients living in the French West Indies. Applying unsuitable and unvalidated tools to them without taking into account local ethnocultural realities would be risky.
The investigators believe it is necessary to adapt the scales used to measure social isolation and loneliness for a population living in the French West Indies.
Through this study, the investigators propose adapting the Lubben Social Network Scale, a social isolation questionnaire, for this population and conducting its psychometric validation.
- Conditions
- Geriatric Assessment, Patients Over 65 Years Old
- Being tested
- Self-assessment questionnaire
- Keywords
- Geriatrics, Lubben Social Network Scale, Transcultural validation, Psychometric validation, Martinique, French West Indies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-assessment questionnaireOther
150 patients aged of 65 or older will pass the Lubben Social Network Scale questionnaire. The Duke Health Profile questionnaire will be also passed by the subject, for the convergent validity.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 65 or older | For the transcultural validation, a french version of the Lubben Social Network Scale questionnaire will be produced. For the psychometric validation, 150 patients aged of 65 or older will pass the questionnaire. The Duke Health Profile questionnaire will be also passed by the subject, for the convergent validity. Receives: Other: Self-assessment questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcultural validation of the Lubben Social Network Scale questionnaire
It will be a question of obtaining a version translated into French. The translated version tested on a small group of patients (15-40) will be submitted to the author of the original version of the tool, along with a report highlighting and explaining all the modifications and difficulties noted by a group of experts.
Measured: 1 month
Psychometric validation of the Lubben Social Network Scale questionnaire
Questionnaire will be passed by 150 subjects. Following parameters will be measured: feasibility and acceptability, validity, reliability, and sensitivity to change.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric AssessmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909591
- Sponsor's protocol ID
- 24_RIPH3-05
- Other IDs
- 2024-A02609-38
- Acronym
- VALLUB
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural and Psychometric Validation of the Lubben Social Network Scale in Older Adults Living in the French West Indies
- ClinicalTrials.gov ID
- NCT06909591
- Acronym / sponsor ID
- VALLUB / 24_RIPH3-05
- Conditions
- Geriatric Assessment, Patients Over 65 Years Old
- Keywords
- Geriatrics, Lubben Social Network Scale, Transcultural validation, Psychometric validation, Martinique, French West Indies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Apr 2025 (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.
Social isolation and loneliness are common among older adults. They are associated with high morbidity and mortality, with an impact comparable to that of other known risk factors such as obesity, a sedentary lifestyle, smoking, etc.
To date, there is no tool to measure social isolation and loneliness for patients living in the French West Indies. Applying unadapted and unvalidated tools to them without taking into account local ethnocultural realities would be risky.
The investigators believe it is necessary to adapt the scales used to measure social isolation and loneliness for a population living in the French West Indies.
Through this study, the investigators propose adapting the Lubben Social Network Scale, a social isolation questionnaire, for this population and conducting its psychometric validation.
Detailed description
Social isolation and loneliness are common among older adults. They are associated with high morbidity and mortality, with an impact comparable to that of other known risk factors such as obesity, a sedentary lifestyle, smoking, etc.
Loneliness is a subjective concept of social relationships, most often reflecting a negative feeling.
Social isolation, on the other hand, is an objective concept of social relationships and refers to infrequent or rare contact with family and friends and can also include living alone.
The feeling of loneliness is linked to social isolation, although the association is only partial.
Indeed, some socially isolated people do not always experience loneliness; and some people living alone are not always socially isolated.
Two theories of loneliness argue that a mismatch between expectations and realities of social contact (cognitive theory) and a lack of intimate or social relationships (deficit theory) can lead to feelings of social or emotional loneliness.
A meta-analysis showed that the risk of premature death was 26% higher in people experiencing loneliness, 29% higher in those who were socially isolated, and 32% higher in the group living alone.
Another meta-analysis examined the effects of loneliness and social isolation on (among other things) mortality. The results showed that loneliness and social isolation were significantly associated with an increased risk of mortality.
The authors conclude that further research is needed to confirm whether loneliness and social isolation have a direct impact on mortality, or whether the association is indirect via the cardiovascular system and psychological health.
To date, there is no tool to measure social isolation and loneliness for patients living in the French West Indies. Applying unsuitable and unvalidated tools to them without taking into account local ethnocultural realities would be risky.
The investigators believe it is necessary to adapt the scales used to measure social isolation and loneliness for a population living in the French West Indies.
Through this study, the investigators propose adapting the Lubben Social Network Scale, a social isolation questionnaire, for this population and conducting its psychometric validation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 65 or older | – | Other: Self-assessment questionnaireFor the transcultural validation, a french version of the Lubben Social Network Scale questionnaire will be produced. For the psychometric validation, 150 patients aged of 65 or older will pass the questionnaire. The Duke Health Profile questionnaire will be also passed by the subject, for the convergent validity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged of 65 or older
Key inclusion criteria (6 listed)
- Patient ≥ 65 years old,
- Hospitalized (Geriatric Day Hospital (HDJ) or Geriatric Medical Care and Rehabilitation Service (SMT)), or seen in geriatric external consultation,
- MMS ≥ 20,
- Patient able to understand and answer a self-administered questionnaire in French,
- Patient having been informed of the research,
Key exclusion criteria (4 listed)
- Patient with sensory disorders preventing completion of the questionnaire,
- Patient unable to consent to participate in the study,
- Patient under legal protection, guardianship, or curatorship,
- Patient who has refused to participate in the study.
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 |
|---|---|---|
| Self-assessment questionnaire150 patients aged of 65 or older will pass the Lubben Social Network Scale questionnaire. The Duke Health Profile questionnaire will be also passed by the subject, for the convergent validity. | Other | Patients aged 65 or older |
Primary outcome
Transcultural validation of the Lubben Social Network Scale questionnaire
Time frame: 1 month
It will be a question of obtaining a version translated into French. The translated version tested on a small group of patients (15-40) will be submitted to the author of the original version of the tool, along with a report highlighting and explaining all the modifications and difficulties noted by a group of experts.
Psychometric validation of the Lubben Social Network Scale questionnaire
Time frame: 24 months
Questionnaire will be passed by 150 subjects. Following parameters will be measured: feasibility and acceptability, validity, reliability, and sensitivity to change.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Assessment and Patients Over 65 Years Old, run by University Hospital Center of Martinique at 1 site in Martinique.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Jun 2025. 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 Martinique. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine SIMO TABUE, MD (05 96 48 81 95 ext. +596, nadine.tabueteguo@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcultural validation of the Lubben Social Network Scale questionnaire (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2025.