Map of Unwanted Loneliness | NCT06167252

Studies
Map of Unwanted Loneliness

NCT06167252

Sponsor

José Joaquín Mira Solves

Status

Completed

Last Update Posted

Apr 1, 2025Actual

Enrollment

992Actual

Phase

Not provided

Conditions

Loneliness

Interventions

Exploration of a database

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Nov 30, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Dec 4, 2023

First Submission Date that Met QC Criteria

Dec 4, 2023

First Posted Date

Dec 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Apr 1, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

José Joaquín Mira Solves, Professor, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaSponsor-Investigator

Lead Sponsor

José Joaquín Mira SolvesOTHER

Collaborators

Name	Class
Centro Internacional para la Investigación del Envejecimiento	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Creating a map of the magnitude of the problem and the response of primary care to unwanted loneliness among the elderly, stratifying different needs based on place of residence and proximity to available assistance programs to address this issue, which, due to its scale, calls for collaboration among various institutions, disciplines, and experiences.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

992Actual

Name	Type	Description	Arm Group Labels	Other Names
Exploration of a database	Other	extraction of data

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NH	Number of hospitalizations	21 months

Secondary Outcomes

Measure	Description	Time Frame
NFMV	Number of family medicine visits	21 months
NPCNV	Number of primary care nursing visits	21 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Population aged 65 or older.
Registration of medical records related to unanticipated loneliness.
Patients with diagnoses of anxiety disorders (CIE-10 F41.1, F41.2, F41.8, F41.9, F43.2, F45, F48) or insomnia (CIE-10 F51) or affective disorders (CIE-10 F34.1) or somatization (CIE-10 F45.0) or pathological grief (CIE-10 Z63.4) or those referred to mental health or social worker services.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Population aged 65 or older who attend one of the 10 primary care centers participating in the provinces of Alicante and Valencia between March 1, 2022, and December 31, 2023.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided