DementiaNCT04589637
Factors Influencing the Deterioration From Cognitive Decline of Normal Aging to Dementia Among Nursing Home Residents
An observational study of Dementia, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Background: A dearth of differential research exists regarding the determinants of mild cognitive impairment (MCI) and moderate cognitive impairment or dementia among nursing home residents. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Dementia
- How many people
- 182 participants
- Where
- 1 siteJordan
- Study dates
- 29 May 2018to 16 May 2019
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: Convenience sampling of 182 participants was used to obtain moderate size correlation (r = 0.35), given a power of 0.80, two-sided Type I error rate of p = 0.0167, based on nQuery calculation [16]. The participants were recruited from 5 holistic nursing homes, including private and public nursing homes, located in the center of Jordan. Inclusion criteria were as follows: Jordanian participants, aged 60 years and older, and living in nursing homes. Exclusion criteria were neurological disorders, such as stroke or brain injury.
Who may be able to join
- Jordanian participants, aged 60 years and older, and living in nursing homes
Who cannot join
- neurological disorders, such as stroke or brain injury
Trial locations and contacts
1 site in 1 country.
About this study
Background: A dearth of differential research exists regarding the determinants of mild cognitive impairment (MCI) and moderate cognitive impairment or dementia among nursing home residents. This study aimed to identify and examine the association between medical factors (number of comorbidities, hospitalization, disability, depression, frailty and quality of life) and moderate cognitive impairment or dementia in nursing homes residents.
Methods: A cross-sectional design was used in this study. Convenience sampling of 182 participants was conducted in nursing homes located in the central part of Jordan. Montreal cognitive assessment (MoCA) was used to screen both MCI and moderate cognitive impairment or dementia. Bivariate analysis, including t-test and ANOVA test, and logistic and linear regression models were used to examine and identify the medical factors associated with moderate cognitive impairment or dementia compared to mild cognitive impairment.
- Conditions
- Dementia
- Medical subject headings
- Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
moderate cognitive impairment
Measured: May, 2018-May, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start29 May 2018
- Primary completion1 Dec 2018
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589637
- Sponsor's protocol ID
- JUST20180229
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kijowska V, Szczerbinska K. Prevalence of cognitive impairment among long-term care residents: a comparison between nursing homes and residential homes in Poland. Eur Geriatr Med. 2018 Aug;9(4):467-476. doi: 10.1007/s41999-018-0062-2. Epub 2018 May 16.
PubMed 34674486Hayajneh, A.A. , Ivanov, L.L. & Rababa, M. (2019). Jordanian Nursing Homes: Admission Policy Analysis. Global Journal of Health Science, 11 (6), 118-122.
Janet D. Elashoff. nQuery Advisor Version 7.0 [software]. 2007: User's Guide. Los Angeles, CA
The Montreal Cognitive Assessment (MoCA). What are the severity levels for the MoCA?. : Copyright 2019 Ziad Nasreddine MD. All rights reserved. Available from:: https://www.mocatest.org/faq/ [30August2020]
Greenberg, S. Try this: the Geriatric Depression Scale (GDS). 2012: 4. The Hartford Institute for Geriatric Nursing, New York University, College of Nursing.
Hayajneh, A. A. The Psychometric Properties of the Arabic Version of the Tilburg Frailty Indicator. Global Journal of Health Science. 2019: 11(9), 123-133. doi:10.5539/gjhs.v11n9p123
Al-btoush, A. Relation between the Psychological Impact of Presbycusis and Hearing Handicap Inventory for the Elderly Using Screening Version in Jordan. Middle East Journal of Age and Ageing. 2012: 9(5), 23-25.
Abdelmoneium, A.O. & Alharahsheh, S.T. Family Home Caregivers for Old Persons in the Arab Region: Perceived Challenges and Policy Implications. Open Journal of Social Sciences. 2016: 4, 151-164. http://dx.doi.org/10.4236/jss.2016.41019
Arafa, Mohamed A., What's New in the Residential Care of the Elderly in the Arab and Islamic World? The Case of Egypt. Towards Human Rights in Residential Care for Older Persons: International Perspectives. 2015: (Chapter 2, Routledge, London & New York), Available at SSRN: https://ssrn.com/abstract=2710357
Atif, M., Saleem, Q. & Scahill, S. Depression and mild cognitive impairment (MCI) among elderly patients with type 2 diabetes mellitus in Pakistan: possible determinants. Int J Diabetes Dev Ctries. 2018: 38, 312-320. https://doi.org/10.1007/s13410-017-0600-3
Elliott, I. Poverty and Mental Health: A review to inform the Joseph Rowntree Foundation's Anti-Poverty Strategy. 2016: London: Mental Health Foundation.
Mosti C.B., Rog L.A., Fink J.W. Differentiating Mild Cognitive Impairment and Cognitive Changes of Normal Aging. In: Ravdin L., Katzen H. (eds) Handbook on the Neuropsychology of Aging and Dementia. Clinical Handbooks in Neuropsychology. 2019. Springer, Cham
Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
PubMed 25514304Qarni T, Salardini A. A Multifactor Approach to Mild Cognitive Impairment. Semin Neurol. 2019 Apr;39(2):179-187. doi: 10.1055/s-0039-1678585. Epub 2019 Mar 29.
PubMed 30925611Ferreira AR, Dias CC, Fernandes L. Needs in Nursing Homes and Their Relation with Cognitive and Functional Decline, Behavioral and Psychological Symptoms. Front Aging Neurosci. 2016 Apr 21;8:72. doi: 10.3389/fnagi.2016.00072. eCollection 2016.
PubMed 27148044
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Deterioration From Cognitive Decline of Normal Aging to Dementia Among Nursing Home Residents
- ClinicalTrials.gov ID
- NCT04589637
- Acronym / sponsor ID
- JUST20180229
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 19 Oct 2020 (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.
Background: A dearth of differential research exists regarding the determinants of mild cognitive impairment (MCI) and moderate cognitive impairment or dementia among nursing home residents. This study aimed to identify and examine the association between medical factors (number of comorbidities, hospitalization, disability, depression, frailty and quality of life) and moderate cognitive impairment or dementia in nursing homes residents.
Methods: A cross-sectional design was used in this study. Convenience sampling of 182 participants was conducted in nursing homes located in the central part of Jordan. Montreal cognitive assessment (MoCA) was used to screen both MCI and moderate cognitive impairment or dementia. Bivariate analysis, including t-test and ANOVA test, and logistic and linear regression models were used to examine and identify the medical factors associated with moderate cognitive impairment or dementia compared to mild cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Convenience sampling of 182 participants was used to obtain moderate size correlation (r = 0.35), given a power of 0.80, two-sided Type I error rate of p = 0.0167, based on nQuery calculation [16]. The participants were recruited from 5 holistic nursing homes, including private and public nursing homes, located in the center of Jordan. Inclusion criteria were as follows: Jordanian participants, aged 60 years and older, and living in nursing homes. Exclusion criteria were neurological disorders, such as stroke or brain injury.
Key inclusion criteria (1 listed)
- Jordanian participants, aged 60 years and older, and living in nursing homes
Key exclusion criteria (1 listed)
- neurological disorders, such as stroke or brain injury
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
moderate cognitive impairment
Time frame: May, 2018-May, 2019
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 19 Oct 2020.
- Background: PubMed 34674486Kijowska V, Szczerbinska K. Prevalence of cognitive impairment among long-term care residents: a comparison between nursing homes and residential homes in Poland. Eur Geriatr Med. 2018 Aug;9(4):467-476. doi: 10.1007/s41999-018-0062-2. Epub 2018 May 16.
- BackgroundHayajneh, A.A. , Ivanov, L.L. & Rababa, M. (2019). Jordanian Nursing Homes: Admission Policy Analysis. Global Journal of Health Science, 11 (6), 118-122.
- BackgroundJanet D. Elashoff. nQuery Advisor Version 7.0 [software]. 2007: User's Guide. Los Angeles, CA
- BackgroundThe Montreal Cognitive Assessment (MoCA). What are the severity levels for the MoCA?. : Copyright 2019 Ziad Nasreddine MD. All rights reserved. Available from:: https://www.mocatest.org/faq/ [30August2020]
- BackgroundGreenberg, S. Try this: the Geriatric Depression Scale (GDS). 2012: 4. The Hartford Institute for Geriatric Nursing, New York University, College of Nursing.
- BackgroundHayajneh, A. A. The Psychometric Properties of the Arabic Version of the Tilburg Frailty Indicator. Global Journal of Health Science. 2019: 11(9), 123-133. doi:10.5539/gjhs.v11n9p123
- BackgroundAl-btoush, A. Relation between the Psychological Impact of Presbycusis and Hearing Handicap Inventory for the Elderly Using Screening Version in Jordan. Middle East Journal of Age and Ageing. 2012: 9(5), 23-25.
- BackgroundAbdelmoneium, A.O. & Alharahsheh, S.T. Family Home Caregivers for Old Persons in the Arab Region: Perceived Challenges and Policy Implications. Open Journal of Social Sciences. 2016: 4, 151-164. http://dx.doi.org/10.4236/jss.2016.41019
- BackgroundArafa, Mohamed A., What's New in the Residential Care of the Elderly in the Arab and Islamic World? The Case of Egypt. Towards Human Rights in Residential Care for Older Persons: International Perspectives. 2015: (Chapter 2, Routledge, London & New York), Available at SSRN: https://ssrn.com/abstract=2710357
- BackgroundAtif, M., Saleem, Q. & Scahill, S. Depression and mild cognitive impairment (MCI) among elderly patients with type 2 diabetes mellitus in Pakistan: possible determinants. Int J Diabetes Dev Ctries. 2018: 38, 312-320. https://doi.org/10.1007/s13410-017-0600-3
- BackgroundElliott, I. Poverty and Mental Health: A review to inform the Joseph Rowntree Foundation's Anti-Poverty Strategy. 2016: London: Mental Health Foundation.
- BackgroundMosti C.B., Rog L.A., Fink J.W. Differentiating Mild Cognitive Impairment and Cognitive Changes of Normal Aging. In: Ravdin L., Katzen H. (eds) Handbook on the Neuropsychology of Aging and Dementia. Clinical Handbooks in Neuropsychology. 2019. Springer, Cham
- 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 Dementia, run by Jordan University of Science and Technology at 1 site in Jordan.
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 1 inclusion and 1 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 19 Oct 2020. 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 Jordan. 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?
moderate cognitive impairment (time frame: May, 2018-May, 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04589637, which also lists 46 linked publications.
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 19 Oct 2020.