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Validation of a Psychological Fragility Questionnary in the Elderly in Isolation (MUTAC)

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ClinicalTrials.gov Identifier: NCT02914080
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:

Social isolation and loneliness of the elderly have become major public health problems, because of the deleterious consequences if not lethal they can generate.

Because of frequent resignation to these phenomena, support must be given to all means of prevention to prevent or at least mitigate their impacts. It appears from the literature that are isolated or living as they have adjustment difficulties which are linked to fragility. If geriatric frailty have been defined to date in somatic and cognitive criteria, psychological fragility criteria have been little discussed outside of psychiatric disorders (depression, anxiety disorders in particular).

This study aims to test in the elderly in isolation psychological fragility questionnaire and to study the statistical qualities and relations with socio-demographic variables, environmental and other known vulnerabilities.


Condition or disease
Loneliness

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Study Start Date : November 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016
Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Psychological scales used to evaluate the elements of fragility in the elderly in isolation [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly people living in isolation , will be tested in different environments : ( i) in rural areas; ( Ii ) in urban areas ; ( Iii) accommodation facility for elderly dependents ( EHPAD)
Criteria

Inclusion Criteria:

  • People over 65
  • Living alone at home (rural and urban ) or institution ( nursing home , no family member or spouse in the same institution).
  • No not refusing to participate in the survey

Exclusion Criteria:

  • Overt or decompensated psychiatric pathology: major depressive disorder , bipolar disorder, psychotic disorder, severe personality disorder , primary addiction ( ICD-10 criteria)
  • Alzheimer's disease or related illness probable or confirmed (ICD criteria 10)
  • Sequel to severe neurological disease , unstabilized somatic pathology and / or may disrupt data collection
  • Patients do not have the capacity to understand the objectives of the survey
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914080


Contacts
Contact: BENOIT Michel, PH benoit.m@chu-nice.fr

Locations
France
CHU Nice Recruiting
Nice, France, 06000
Contact: Benoit Michel, PH       benoit.m@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02914080     History of Changes
Other Study ID Numbers: 14-PP-09
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No