A Rising Drug Burden Index, Not Anticholinergic Burden, is Related With Malnutrition in Community-dwelling Older Adults With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- Number of participants with malnutrition, malnutrition risk and healthy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of any type of demantia
- •Must be able to swallow tablets
- •Must be recorded data of medications and doses
排除标准
- •Psychiatric disorders
- •Mild cognitive impairment
- •End-stage diseases (renal, liver, cardiac)
- •Uncontrolled thyroid functions
结局指标
主要结局
Number of participants with malnutrition, malnutrition risk and healthy
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点
研究者
Sultan Keskin Demircan
Principal Investigator
Gulhane Training and Research Hospital