NCT07165574

Brief Summary

This study investigates the anticholinergic burden on patients seen in the Subacute mobile outpatient geriatric clinic in Aalborg, Denmark, between the years of 2024 and 2025. The age demographic in Denmark and multiple other countries is changing rapidly, with more old and very old individuals as a result. As humans become older, they tend to accumulate more illnesses, and the risk of polypharmacy increases. There is a wide selection of medicine that affect the binding of acetylcholine to the muscarinic receptors, which is either the intended function of the pharmacological product or a side effect. Since there is no built-in feature in computer systems used by doctors to calculate the cumulative anticholinergic burden, it is often not recognized, thus not reflected upon. This raises concerns about potential central and peripheral side effects, such as altered mental status, visual disturbances, tachycardia, urinary and fecal retention, dry skin etc. The study aims to determine the prevalence of anticholinergics in the last 100 patients seen by the Subacute mobile outpatient geriatric clinic in Aalborg University Hospital. The patients are placed in municipal extended-care facilities. Furthermore, the study will investigate the prevalence of anticholinergic side effects concerning the burden on this population. The study is a retrospective chart review of patient charts from the years of 2024 and 2025, analyzing patient characteristics, comorbidities, medication lists, and calculating the anticholinergic burden through the ACB calculator.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress51%
Sep 2025Jan 2027

First Submitted

Initial submission to the registry

August 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

September 10, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 28, 2025

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of anticholinergics

    Number of patients taking anticholinercis (yes/no) defined by the Anticholingeric Cognitive Burden scale (any score above 0)

    Day 1. That is on the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital

Secondary Outcomes (2)

  • Prevalence of central side effects

    On the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital

  • Prevalence of peripheral anticholinergic side effects

    On the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital

Interventions

As this is an observation study, participants are not assigned an intervention as part of the study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient seen by the subactue outpatient geratric clinic at Aalborg University Hospital are older adults who have experienced an acute deterioration of daily function, usually due to acute illness and are admittet to municipality reablement services with the goal of postacute rehabilitation to previous funciton and avoiding nursing home admission. Patients may have been recently discharged from hospital.

You may qualify if:

  • patients seen by the Subacute outpatient geriatric clinic at Aalborg University hospital, Denmark, between 2024 and 2025.
  • Consecutive sampling starting with the most recent patient chart and going backwards.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Geriatric Medicine, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Anticholinergic Syndrome

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Central Study Contacts

Johannes Riis, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 10, 2025

Study Start

September 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

September 10, 2025

Record last verified: 2025-08

Locations