LonelinessMUTACNCT02914080
Validation of a Psychological Fragility Questionnary in the Elderly in Isolation
An observational study of Loneliness, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Loneliness
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Loneliness
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological scales used to evaluate the elements of fragility in the elderly in isolation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914080
- Sponsor's protocol ID
- 14-PP-09
- Acronym
- MUTAC
- Status last verified
- Jul 2018
- First submitted
- 13 Sep 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Psychological Fragility Questionnary in the Elderly in Isolation
- ClinicalTrials.gov ID
- NCT02914080
- Acronym / sponsor ID
- MUTAC / 14-PP-09
- Conditions
- Loneliness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychological scales used to evaluate the elements of fragility in the elderly in isolation
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Loneliness, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological scales used to evaluate the elements of fragility in the elderly in isolation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.