- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06909591
Transcultural and Psychometric Validation of the Lubben Social Network Scale in Older Adults Living in the French West Indies (VALLUB)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nadine SIMO TABUE, MD
- Phone Number: +596 05 96 48 81 95
- Email: nadine.tabueteguo@chu-martinique.fr
Study Locations
-
-
-
Fort-de-France, Martinique, 97261
- CHU of Martinique
-
Contact:
- Nadine SIMO TABUE, MD
- Phone Number: +596 05 96 48 81 95
- Email: nadine.tabueteguo@chu-martinique.fr
-
Principal Investigator:
- Nadine SIMO TABUE, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month
|
|
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.
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 24_RIPH3-05
- 2024-A02609-38 (Registry Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Geriatric Assessment
-
Sichuan Cancer Hospital and Research InstituteEnrolling by invitationGeriatric Assessment | Geriatric Patients | Assessment Tool | Patients With CancerChina
-
City of Hope Medical CenterNational Institutes of Health (NIH)CompletedAssessment, GeriatricUnited States
-
Groupe Hospitalier Mutualiste de GrenobleRecruitingGeriatric AssessmentFrance
-
Ardea OutcomesNational Research Council, CanadaCompleted
-
Washington University School of MedicineCompleted
-
University of AarhusDanish Cancer SocietyCompletedCancer | Geriatric AssessmentDenmark
-
Assistance Publique - Hôpitaux de ParisCompletedMultimorbidity | Geriatric AssessmentFrance
-
Istanbul University - CerrahpasaEnrolling by invitationGeriatric Population | Fall Risk Assessment | Tele-assessment ReliabilityTurkey (Türkiye)
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalActive, not recruitingNutrition Assessment | Geriatric AnesthesiaTurkey (Türkiye)
-
Sichuan Cancer Hospital and Research InstituteNot yet recruitingGeriatric Assessment | Solid Cancers
Clinical Trials on Self-assessment questionnaire
-
Assistance Publique Hopitaux De MarseilleNot yet recruiting
-
University Hospital of FerraraCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedVitiligo | PHOTOPROTECTION | SUN-EXPOSITION | FITZPATRICK SCALEFrance
-
Mario Negri Institute for Pharmacological ResearchIRCCS Multimedica; Centro Cardiologico MonzinoCompletedEpidemiology of Cardiovascular RiskItaly
-
Acibadem UniversityNot yet recruitingParkinson Disease, Symptom Severity, Functional Status, Quality of Life, Self-compassion, and Self-efficacy
-
GlaxoSmithKlineTerminated
-
Gazi UniversityNot yet recruitingShoulder Arthroscopy | Surgeon SatisfactionTurkey
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinRecruitingChildren Born to Mothers Enrolled in the TOCOPROM TrialFrance
-
Sahlgrenska University Hospital, SwedenCompletedParkinson DiseaseSweden
-
Hasanuddin UniversityCompletedBurnout Syndrome | Self EfficacyIndonesia