FrailtyNCT04233541
Frailty Status and Increased Risk for Falls
An observational study of Frailty and Fall, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
We hypothesized that the use of anticholinergic medications may precipitate falls differently by frailty status in older adults. Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic prospectively enter into the study. Frailty status is defined according to the Physical Frailty Phenotype. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Fall, Anticholinergic Toxicity
- What is being tested?
- Fall assessment
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic
Who may be able to join
- Community-dwelling older adults
Who cannot join
- a history of dementia,
- current delirium or psychotic symptoms,
- taking antipsychotic medications,
- being functionally dependent to others,
- difficulty in communicating with the interviewer,
- terminal illness,
Show all 9Show fewer
- being bedridden or wheelchair bound (≥2 weeks),
- difficulty in standing or walking,
- incomplete data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
Ankara, 06010
Mehmet I Naharci, Assoc.Prof., 905445120147, drnaharci@yahoo.com
About this study
Official title: Frailty Status and Increased Risk for Falls: The Role of Anticholinergic Burden
We hypothesized that the use of anticholinergic medications may precipitate falls differently by frailty status in older adults. Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic prospectively enter into the study. Frailty status is defined according to the Physical Frailty Phenotype. The drugs are categorized according to the ACB scale
Read the detailed description
Previous studies have found that the use of drugs with anticholinergic properties relate to increased prevalence of falls in older women and men. Frailty is associated with serious health outcomes including falls, hip fractures, and death. Frailty can be a relevant target to investigate its association with the risk of falls among the users of drugs with anticholinergic properties. A recent evidence suggests that the interaction between being frail and adverse outcomes in older adults receiving polypharmacy or centrally acting drugs is complex and not straightforward across all frailty phenotypes.
We classify the participants frail if they met at least three of five criteria, while those having one or two criteria were pre-frail, and others were non-frail. We determine the anticholinergic burden by using the Anticholinergic Cognitive Burden (ACB) Scale developed by Boustani et al.
- Conditions
- Frailty, Fall, Anticholinergic Toxicity
- Being tested
- Fall assessment
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall assessmentDiagnostic test
Through a comprehensive geriatric assessment carried out by our geriatrician led multidisciplinary team we gather information about fall recalls consistent with the definition of landing on the floor or ground.
| Study group | Role | What they receive |
|---|---|---|
| Fallers | Participants who reported one or more falls within the 12 months preceding the study consist the group of ''fallers''. Receives: Diagnostic Test: Fall assessment | |
| Non-fallers | Participants with no fall history consist the group of ''non-fallers'' Receives: Diagnostic Test: Fall assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall assessment
We will assess the association between anticholinergic burden (ACB) and falls based on frailty status among older adults.
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 May 2017
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ilkin Naharci, Saglik Bilimleri Universitesi
- Investigators
- Ilker Tasci, Prof., Principal investigator, Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233541
- Sponsor's protocol ID
- 2016/1648-463
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Status and Increased Risk for Falls: The Role of Anticholinergic Burden
- ClinicalTrials.gov ID
- NCT04233541
- Acronym / sponsor ID
- 2016/1648-463
- Conditions
- Frailty, Fall, Anticholinergic Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jan 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.
We hypothesized that the use of anticholinergic medications may precipitate falls differently by frailty status in older adults. Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic prospectively enter into the study. Frailty status is defined according to the Physical Frailty Phenotype. The drugs are categorized according to the ACB scale
Detailed description
Previous studies have found that the use of drugs with anticholinergic properties relate to increased prevalence of falls in older women and men. Frailty is associated with serious health outcomes including falls, hip fractures, and death. Frailty can be a relevant target to investigate its association with the risk of falls among the users of drugs with anticholinergic properties. A recent evidence suggests that the interaction between being frail and adverse outcomes in older adults receiving polypharmacy or centrally acting drugs is complex and not straightforward across all frailty phenotypes.
We classify the participants frail if they met at least three of five criteria, while those having one or two criteria were pre-frail, and others were non-frail. We determine the anticholinergic burden by using the Anticholinergic Cognitive Burden (ACB) Scale developed by Boustani et al.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fallers | – | Diagnostic Test: Fall assessmentParticipants who reported one or more falls within the 12 months preceding the study consist the group of ''fallers''. |
| Non-fallers | – | Diagnostic Test: Fall assessmentParticipants with no fall history consist the group of ''non-fallers'' |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic
Key inclusion criteria (1 listed)
- Community-dwelling older adults
Key exclusion criteria (9 listed)
- a history of dementia,
- current delirium or psychotic symptoms,
- taking antipsychotic medications,
- being functionally dependent to others,
- difficulty in communicating with the interviewer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fall assessmentThrough a comprehensive geriatric assessment carried out by our geriatrician led multidisciplinary team we gather information about fall recalls consistent with the definition of landing on the floor or ground. | Diagnostic test | Fallers, Non-fallers |
Primary outcome
Fall assessment
Time frame: 1-2 hours
We will assess the association between anticholinergic burden (ACB) and falls based on frailty status among older adults.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- 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.
Ilker Tasci, Prof. principal investigator
Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
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 Frailty and Fall, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 9 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: status not confirmed, as of the sponsor's last update on 18 Jan 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet I Naharci, Assoc.Prof. (905445120147, drnaharci@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall assessment (time frame: 1-2 hours). 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 18 Jan 2020.