Frailty in Older AdultsNCT07165574
Prevalence of Anticholinergics in Geriatric Patients With Acute Functional Deterioration
An observational study of Frailty in Older Adults and Functional Decline, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frailty in Older Adults, Functional Decline, Anticholinergic Syndrome
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- Inclusion is based on chart review and all patients are therefore included consecutively.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Geriatric Medicine, Aalborg University Hospital
Aalborg, 9000
About this study
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.
Read more
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.
- Being tested
- No intervention as the study is observational
- Medical subject headings
- Anticholinergic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention as the study is observationalOther
As this is an observation study, participants are not assigned an intervention as part of the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anticholinergics
Number of patients taking anticholinercis (yes/no) defined by the Anticholingeric Cognitive Burden scale (any score above 0)
Measured: 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
Prevalence of any of the following conditions as described in patient charts: Delirium, other confusion, restlessness, hallucinations, Amnesia, dysarthria, ataxia, stupor, coma.
Measured: On the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital
Prevalence of peripheral anticholinergic side effects
Prevalence of any of the following conditions as described in patient charts: Urinary retention, constipation, tachycardia, visual disturbances, dry skin, dry mouth.
Measured: On the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty in Older AdultsStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Riis, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165574
- Sponsor's protocol ID
- 1-45-72-442-25
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anticholinergics in Geriatric Patients With Acute Functional Deterioration
- ClinicalTrials.gov ID
- NCT07165574
- Acronym / sponsor ID
- 1-45-72-442-25
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Sep 2025 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- Inclusion is based on chart review and all patients are therefore included consecutively.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No intervention as the study is observationalAs this is an observation study, participants are not assigned an intervention as part of the study | Other | – |
Primary outcome
Prevalence of anticholinergics
Time frame: Day 1. That is on the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital
Number of patients taking anticholinercis (yes/no) defined by the Anticholingeric Cognitive Burden scale (any score above 0)
2 secondary outcomes
Prevalence of central side effects
Time frame: On the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital
Prevalence of peripheral anticholinergic side effects
Time frame: On the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 in Older Adults and Functional Decline, run by Aalborg University Hospital at 1 site in Denmark.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Sep 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Riis, MD (+45 22174664, johannes0408@live.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anticholinergics (time frame: Day 1. That is on the day of patients first contact with the subacute outpatient geratric function at Aalborg Unviversity Hospital). 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 10 Sep 2025.