Malnutrition SevereNCT06447259
Drug Burden Index is Associated With Malnutrition in Community-dwelling Dementia Patients
An observational study of Malnutrition Severe and Dementia, run by Sultan Keskin Demircan at 1 site in Turkey (Türkiye).
Trial summary
Malnutrition leads to poor clinical outcomes in dementia patients. The investigator aimed to examine the association between drug burden index (DBI) and anticholinergic burden (ACB) scores with nutrition status in community-dwelling older adults with dementia, considering that drugs may contribute malnutrition. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Malnutrition Severe, Dementia, Drug Use
- How many people
- 415 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2023to 10 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 to 100 years
- All sexes
- Older adult
Study population: The data of patients (65 years of age and older) who were applied to a tertiary geriatric outpatient clinic
Who may be able to join
- Clinical diagnosis of any type of demantia
- Must be able to swallow tablets
- Must be recorded data of medications and doses
Who cannot join
- Psychiatric disorders
- Mild cognitive impairment
- End-stage diseases (renal, liver, cardiac)
- Uncontrolled thyroid functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Rising Drug Burden Index, Not Anticholinergic Burden, is Related With Malnutrition in Community-dwelling Older Adults With Dementia
Malnutrition leads to poor clinical outcomes in dementia patients. The investigator aimed to examine the association between drug burden index (DBI) and anticholinergic burden (ACB) scores with nutrition status in community-dwelling older adults with dementia, considering that drugs may contribute malnutrition.
A total of 415 outpatients with dementia, evaluated by Mini Nutrition Assessment test and registered drug information, are included in the study. The investigator calculated the DBI as the sum of all sedatives and anticholinergics taken continuously for at least four weeks prior to admission and evaluated the ACB score.
Practice Impact: Due to accompanying chronic diseases and symptoms, cholinergic and/or sedative-loaded drugs are often prescribed to dementia patients. In this study, İnvestigators emphasized that in addition to the cholinergic loads of the drugs used, their sedative loads and the drug doses they use are also important. Avoiding prescribing these medications to patients with dementia will protect them from malnutrition and its negative consequences.
- Conditions
- Malnutrition Severe, Dementia, Drug Use, Anticholinergic Toxicity
- Keywords
- Drug burden index,, older adults, malnutrition, anticholinergic drugs, dementia
- Medical subject headings
- Dementia, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with malnutrition, malnutrition risk and healthy
Based on the MNA-SF score, each participant was assigned to one of the following three groups: malnutrition (score between 0 and 7), malnutrition risk (score between 8 and 11), and healthy (score from 12 to 14).
Measured: Baseline
Number of participants with high DBI (Drug Burden Index) score
Medications taken consistently at least four weeks prior to admission were considered to be in current use. DBI of drugs containing sedative and cholinergic load was calculated The following formula was used to calculate the DBI = D/ (δ +D), where D represents the daily dose consumed by participants and δ is the minimum recommended is the minimum daily dose that has been established in accordance with the adult dose authorized by the US Food and Drug Administration (FDA) and Turkish authorities in the product information of the drug. Each participant's total DBI score was determined by adding the DBI values for each substance with anticholinergic or sedative effects. Patients were classified as none (DBI=0), low exposure (0<DBI<1), or high exposure (DBI ≥1).
Measured: Baseline
Number of participants with high ACB (Anti Cholinergic Burden) score
Medications taken consistently at least four weeks prior to admission were considered to be in current use.The anticholinergic drug exposure in each patient was assessed by a clinician using the Anticholinergic Cognitive Burden Scale, which grades the anticholinergic activity of each drug into three categories: absence (ACB = 0), possible (ACB = 1), and definite (either ACB = 2 or ACB = 3). The scores for each drug were added up to determine the patient's overall ACB score. All patients were then categorized into three groups: none (ACB score of 0), low to moderate exposure (ACB score of 1 or 2), or high exposure (ACB score of 3 or above)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start20 May 2023
- Primary completion1 Oct 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition SevereStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Keskin Demircan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Sultan Keskin Demircan, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447259
- Sponsor's protocol ID
- GulhaneTR2
- Status last verified
- Apr 2023
- First submitted
- 28 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rising Drug Burden Index, Not Anticholinergic Burden, is Related With Malnutrition in Community-dwelling Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT06447259
- Acronym / sponsor ID
- GulhaneTR2
- Conditions
- Malnutrition Severe, Dementia, Drug Use, Anticholinergic Toxicity
- Keywords
- Drug burden index,, older adults, malnutrition, anticholinergic drugs, dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Sultan Keskin DemircanOther government
- Study start
- 20 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 7 Jun 2024 (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.
Malnutrition leads to poor clinical outcomes in dementia patients. The investigator aimed to examine the association between drug burden index (DBI) and anticholinergic burden (ACB) scores with nutrition status in community-dwelling older adults with dementia, considering that drugs may contribute malnutrition.
A total of 415 outpatients with dementia, evaluated by Mini Nutrition Assessment test and registered drug information, are included in the study. The investigator calculated the DBI as the sum of all sedatives and anticholinergics taken continuously for at least four weeks prior to admission and evaluated the ACB score.
Practice Impact: Due to accompanying chronic diseases and symptoms, cholinergic and/or sedative-loaded drugs are often prescribed to dementia patients. In this study, İnvestigators emphasized that in addition to the cholinergic loads of the drugs used, their sedative loads and the drug doses they use are also important. Avoiding prescribing these medications to patients with dementia will protect them from malnutrition and its negative consequences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Age groups
- Older adult
- Study population
- The data of patients (65 years of age and older) who were applied to a tertiary geriatric outpatient clinic
Key inclusion criteria (3 listed)
- Clinical diagnosis of any type of demantia
- Must be able to swallow tablets
- Must be recorded data of medications and doses
Key exclusion criteria (4 listed)
- Psychiatric disorders
- Mild cognitive impairment
- End-stage diseases (renal, liver, cardiac)
- Uncontrolled thyroid functions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with malnutrition, malnutrition risk and healthy
Time frame: Baseline
Based on the MNA-SF score, each participant was assigned to one of the following three groups: malnutrition (score between 0 and 7), malnutrition risk (score between 8 and 11), and healthy (score from 12 to 14).
Number of participants with high DBI (Drug Burden Index) score
Time frame: Baseline
Medications taken consistently at least four weeks prior to admission were considered to be in current use. DBI of drugs containing sedative and cholinergic load was calculated The following formula was used to calculate the DBI = D/ (δ +D), where D represents the daily dose consumed by participants and δ is the minimum recommended is the minimum daily dose that has been established in accordance with the adult dose authorized by the US Food and Drug Administration (FDA) and Turkish authorities in the product information of the drug. Each participant's total DBI score was determined by adding the DBI values for each substance with anticholinergic or sedative effects. Patients were classified as none (DBI=0), low exposure (0<DBI<1), or high exposure (DBI ≥1).
Number of participants with high ACB (Anti Cholinergic Burden) score
Time frame: Baseline
Medications taken consistently at least four weeks prior to admission were considered to be in current use.The anticholinergic drug exposure in each patient was assessed by a clinician using the Anticholinergic Cognitive Burden Scale, which grades the anticholinergic activity of each drug into three categories: absence (ACB = 0), possible (ACB = 1), and definite (either ACB = 2 or ACB = 3). The scores for each drug were added up to determine the patient's overall ACB score. All patients were then categorized into three groups: none (ACB score of 0), low to moderate exposure (ACB score of 1 or 2), or high exposure (ACB score of 3 or above)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Malnutrition Severe and Dementia, run by Sultan Keskin Demircan at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 7 Jun 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with malnutrition, malnutrition risk and healthy (time frame: Baseline). The study lists 3 primary outcomes in all. 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 7 Jun 2024.