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

Completed

• Conditions: Dementia; Anticholinergic Toxicity; Malnutrition Severe; Drug Use

• Registration Number: NCT06447259
• Lead Sponsor: Sultan Keskin Demircan

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-05-20
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-10
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-01
• Last Update Submitted: 2024-06-01
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with malnutrition, malnutrition risk and healthy	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	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	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)

Trial Locations

Locations (1)

Sultan Keskin Demircan; 🇹🇷 Ankara, Turkey