NCT06909591

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress30%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

March 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 15, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

March 27, 2025

Last Update Submit

June 12, 2025

Conditions

Keywords

GeriatricsLubben Social Network ScaleTranscultural validationPsychometric validationMartiniqueFrench West Indies

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    24 months

Study Arms (1)

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.

Other: Self-assessment questionnaire

Interventions

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.

Patients aged 65 or older

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged of 65 or older

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Martinique

Fort-de-France, 97261, Martinique

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 3, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 15, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations