Frailty Status and Increased Risk for Falls

NCT ID: NCT04233541

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Frailty Fall Anticholinergic Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fallers

Participants who reported one or more falls within the 12 months preceding the study consist the group of ''fallers''.

Fall assessment

Intervention Type DIAGNOSTIC_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.

Non-fallers

Participants with no fall history consist the group of ''non-fallers''

Fall assessment

Intervention Type DIAGNOSTIC_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.

Interventions

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Fall assessment

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Community-dwelling older adults

Exclusion Criteria

* 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,
* being bedridden or wheelchair bound (≥2 weeks),
* difficulty in standing or walking,
* incomplete data
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Ilkin Naharci

Assoc.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilker Tasci, Prof.

Role: PRINCIPAL_INVESTIGATOR

Gulhane Faculty of Medicine & Gulhane Training and Research Hospital

Locations

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Gulhane Faculty of Medicine & Gulhane Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet I Naharci, Assoc.Prof.

Role: CONTACT

905445120147

Facility Contacts

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Mehmet I Naharci, Assoc.Prof.

Role: primary

905445120147

Other Identifiers

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2016/1648-463

Identifier Type: -

Identifier Source: org_study_id

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