NCT04233541

Brief 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. The drugs are categorized according to the ACB scale

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

January 15, 2020

Last Update Submit

January 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fall assessment

    We will assess the association between anticholinergic burden (ACB) and falls based on frailty status among older adults.

    1-2 hours

Study Arms (2)

Fallers

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

Diagnostic Test: Fall assessment

Non-fallers

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

Diagnostic Test: Fall assessment

Interventions

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.

FallersNon-fallers

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic

You may qualify if:

  • Community-dwelling older adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Faculty of Medicine & Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ilker Tasci, Prof.

    Gulhane Faculty of Medicine & Gulhane Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet I Naharci, Assoc.Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

May 1, 2017

Primary Completion

January 31, 2020

Study Completion

December 31, 2025

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations