Map of Unwanted Loneliness

March 26, 2025 updated by: José Joaquín Mira Solves
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

992

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alicante, Spain
        • FISABIO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NH
Time Frame: 21 months
Number of hospitalizations
21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NFMV
Time Frame: 21 months
Number of family medicine visits
21 months
NPCNV
Time Frame: 21 months
Number of primary care nursing visits
21 months
NPSWV
Time Frame: 21 months
Number of primary care social work visits
21 months
NFPV
Time Frame: 21 months
Number of primary care physiotherapy visits
21 months
NCPHV
Time Frame: 21 months
Number of primary care home consultations
21 months
NCEPV
Time Frame: 21 months
Number of primary care emergency consultations
21 months
NHD
Time Frame: 21 months
Number of hospitalization days
21 months
NTDMGE
Time Frame: 21 months
Number of total daily medications (general and related to emotional condition)
21 months
NTEM
Time Frame: 21 months
Number of total daily medications (related only to emotional condition)
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • UGP-23-189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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