Frailty Status and Increased Risk for Falls

January 15, 2020 updated by: Mehmet Ilkin Naharci, Saglik Bilimleri Universitesi

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

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Ankara, Turkey, 06010
        • Recruiting
        • Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fallers
Participants who reported one or more falls within the 12 months preceding the study consist the group of ''fallers''.
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''
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ilker Tasci, Prof., Gulhane Faculty of Medicine & Gulhane Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

January 31, 2020

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1648-463

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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