Drug Burden Index is Associated With Malnutrition in Community-dwelling Dementia Patients

Dementia Clinical Trial

Official title:

A Rising Drug Burden Index, Not Anticholinergic Burden, is Related With Malnutrition in Community-dwelling Older Adults With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06447259
• Other study ID #: GulhaneTR2
• Status: Completed
• Start date: May 20, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: April 2023
• Source: Gulhane Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: December 10, 2023
• Est. primary completion date: October 1, 2023
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of any type of demantia

• Must be able to swallow tablets

• Must be recorded data of medications and doses

Exclusion Criteria:

• Psychiatric disorders

• Mild cognitive impairment

• End-stage diseases (renal, liver, cardiac)

• Uncontrolled thyroid functions

Related Conditions & MeSH terms

• Anticholinergic Toxicity
• Dementia
• Drug Use
• Malnutrition
• Malnutrition Severe

Locations

Country	Name	City	State
Turkey	Sultan Keskin Demircan	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Keskin Demircan

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Primary	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/ (d +D), where D represents the daily dose consumed by participants and d 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	Baseline
Primary	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)	Baseline