- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167252
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
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
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Alicante, Spain
- FISABIO
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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
|
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NPCNV
Time Frame: 21 months
|
Number of primary care nursing visits
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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
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21 months
|
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NCPHV
Time Frame: 21 months
|
Number of primary care home consultations
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21 months
|
|
NCEPV
Time Frame: 21 months
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Number of primary care emergency consultations
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21 months
|
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NHD
Time Frame: 21 months
|
Number of hospitalization days
|
21 months
|
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NTDMGE
Time Frame: 21 months
|
Number of total daily medications (general and related to emotional condition)
|
21 months
|
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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.
Sponsor
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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