Neurocognitive Disorder, Etiology of Neurocognitive DisorderNCT05404152
Evaluation of Cognitive Impairment in the Elderly Admitted to Nursing Homes
An observational study of Neurocognitive Disorder, Etiology of Neurocognitive Disorder, run by Universidad de Murcia at 1 site in Spain.
Trial summary
This research aims at analysing the profile of the elderly with cognitive impairment (IC) and inquiring about the mental illnesses that cause cognitive impairment of a population (elderly admitted to nursing homes with a high incidence). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neurocognitive Disorder, Etiology of Neurocognitive Disorder
- How many people
- 390 participants
- Where
- 1 siteSpain
- Study dates
- 31 Dec 2021to 1 May 2022
- 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 60 years and older
- All sexes
- Adult, Older adult
Study population: * Elderly without cognitive assessment at admission * Existence of doubts about the presence of IC
Who may be able to join
- Vounteer
- Elderly Admitted to Nursing homes
- From 60 years old
Who cannot join
- Elderly without cognitive assessment at admission
- Existence of doubts about the presence of IC
Trial locations and contacts
1 site in 1 country.
About this study
This research aims at analysing the profile of the elderly with cognitive impairment (IC) and inquiring about the mental illnesses that cause cognitive impairment of a population (elderly admitted to nursing homes with a high incidence).
Read the detailed description
The objectives of these studies are to determine the presence of IC and the profile of users who suffer from it in 8 nursing homes in the province of Pontevedra of new admission in 2017, as well as the identification of the frequency of underdiagnosis in the filiation of the mental pathology that causes IC and if that underdiagnosis is related to the presence of doctors or nurses specialists in geriatrics. Sociodemographic, clinical (with special relevance in cognitive assessment and the presence of mental disorders) and functional variables will be analyzed. In addition to providing information that can improve the DC early detection as well as the scarcity of studies in this field, the importance of this research is justified by developing treatment guidelines for people with IC in the future
- Keywords
- Cognitive impairment, nursing home, neurocognitive disorder
- Medical subject headings
- Neurocognitive Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ederly | Elderly Admitted to Nursing homes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of Evaluation of Cognitive Impairment. MEC o MMSE <24 points or diagnosis of Neurocognitive disorder
Measured: Two years
Secondary outcomes (1)
Statistical correlation of CI with educational level.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start31 Dec 2021
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive Disorder, Etiology of Neurocognitive DisorderStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA ELENA MOSQUERA LOSADA, Universidad de Murcia
- Investigators
- MARIA ELENA MOSQUERA LOSADA, MSc in Nursing, Principal investigator, Universidad de MurciaANTONIA GOMEZ-CONESA, PhD, PT, Study director, Universidad de MurciaRAMON GONZALEZ CABANACH, PhD, Study director, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404152
- Sponsor's protocol ID
- CIE/UM22
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive Impairment in the Elderly Admitted to Nursing Homes
- ClinicalTrials.gov ID
- NCT05404152
- Acronym / sponsor ID
- CIE/UM22
- Keywords
- Cognitive impairment, nursing home, neurocognitive disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 3 Jun 2022 (actual)
- 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.
This research aims at analysing the profile of the elderly with cognitive impairment (IC) and inquiring about the mental illnesses that cause cognitive impairment of a population (elderly admitted to nursing homes with a high incidence).
Detailed description
The objectives of these studies are to determine the presence of IC and the profile of users who suffer from it in 8 nursing homes in the province of Pontevedra of new admission in 2017, as well as the identification of the frequency of underdiagnosis in the filiation of the mental pathology that causes IC and if that underdiagnosis is related to the presence of doctors or nurses specialists in geriatrics. Sociodemographic, clinical (with special relevance in cognitive assessment and the presence of mental disorders) and functional variables will be analyzed. In addition to providing information that can improve the DC early detection as well as the scarcity of studies in this field, the importance of this research is justified by developing treatment guidelines for people with IC in the future
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ederly | – | –Elderly Admitted to Nursing homes |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Elderly without cognitive assessment at admission * Existence of doubts about the presence of IC
Key inclusion criteria (3 listed)
- Vounteer
- Elderly Admitted to Nursing homes
- From 60 years old
Key exclusion criteria (2 listed)
- Elderly without cognitive assessment at admission
- Existence of doubts about the presence of IC
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
Study of Evaluation of Cognitive Impairment. MEC o MMSE <24 points or diagnosis of Neurocognitive disorder
Time frame: Two years
1 secondary outcome
Statistical correlation of CI with educational level.
Time frame: Two 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 5 Jul 2022.
- Individual participant dataSharing planned: Yes
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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.
MARIA ELENA MOSQUERA LOSADA, MSc in Nursing principal investigator
Universidad de Murcia
ANTONIA GOMEZ-CONESA, PhD, PT study director
Universidad de Murcia
RAMON GONZALEZ CABANACH, PhD study director
Universidade da Coruña
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 Neurocognitive Disorder, Etiology of Neurocognitive Disorder, run by Universidad de Murcia at 1 site in Spain.
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 2 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 5 Jul 2022. 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 Spain. 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?
Study of Evaluation of Cognitive Impairment. MEC o MMSE <24 points or diagnosis of Neurocognitive disorder (time frame: Two 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 5 Jul 2022.