Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 706
- 试验地点
- 2
- 主要终点
- Total Standardized Daily Dose (TSDD) - From Medical Records
研究概览
简要总结
This study is an RCT to evaluate the effectiveness of Brain Safe on reducing anticholinergic exposure. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.
详细描述
This study is a randomized clinical trial (RCT) of the efficacy of a direct-to-consumer intervention called Brain Safe to primarily reduce older adults' exposure to prescription anticholinergics and secondarily improve cognitive function and health-related quality of life. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.
The primary objective is to test the effect of Brain Safe on anticholinergic exposure at 12 months. We hypothesize that anticholinergic exposure will be lower among those randomized to the Brain Safe intervention compared to those randomized to the attention control app at 12 months. Our primary, powered outcome is the total standard daily dose (TSDD) measure of anticholinergic exposure at 12 months, which is calculated over the preceding 6 months of prescription data. We will electronically capture prescription data monthly and compute TSDD at baseline, 6, and 12 months.
The secondary objective is to test the effect of Brain Safe on: (a) cognitive function and (b) health-related quality of life at 12 months. We hypothesize older adults randomized to Brain Safe will have higher (a) cognitive function, measured by using an objective, performance-based composite, and (b) health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months.
Exploratory objectives are to test the effect of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months. This aim will explore the presence of early effects of Brain Safe at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The primary investigator and outcome assessor will be masked to the App assignment (Brain Safe vs Attention Control Medication list App)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 1 primary care visit at Eskenazi Health or IU Health in past 12 months
- •Age ≥ 60 years
- •Written informed consent and HIPAA authorization for the release of personal health information.
- •English-speaking
- •At least one prescription for a strong anticholinergic medication with Anticholinergic Cognitive Burden (ACB) score 2 or 3 in prior 12 months, and currently using it
- •Community-dwelling in Central Indiana
- •Not cognitively impaired
- •Not terminally ill
- •Not sensory impaired (after correction)
排除标准
- •Permanent resident of an extended care facility (nursing home); independent or assisted senior care living is allowed if managing own medications.
- •Diagnosis of Alzheimer's disease or related dementia (ADRD), determined by International Classification of Diseases (ICD)-9/ICD-10 codes or current use of a medication for ADRD
- •Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by ICD-9/ICD-10 codes
- •Involvement in another clinical trial that would prevent or interfere with study objectives
- •Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
- •Not currently using anticholinergic medication
研究组 & 干预措施
Brain Safe App
1)Brain Safe App provides conversation starters for older adult patients on target anticholinergics. The conversation starters assist the patient to have discussions with their physicians regarding reduction in exposure to prescription anticholinergics. 2) Provides anticholinergic risk assessment.
干预措施: Brain Safe App (Other)
Attention Control App
1) Attention Control App provides a medication list for older patients to use but lacks the conversation starters for patient to use with there physicians aimed at reduction in exposure to prescription anticholinergics.2) No anticholinergic risk assessment.
干预措施: Attention Control App (Other)
结局指标
主要结局
Total Standardized Daily Dose (TSDD) - From Medical Records
时间窗: Baseline, 6 months, 12 Months
To calculate the Total Standardized Daily Dose (TSDD), we first calculated the Standardized Daily Dose (SDD) for each anticholinergic medication with an ACB Score of 2 or 3. SDD was calculated by multiplying the strength by the units per dose and frequency per day and number of refills. The product was divided by the minimum effective daily dose (where available) or the minimum effective geriatric dose to standardize the quantity across multiple classes of medications. The SDD for all anticholinergics with an ACB score 2 or 3 was then summed for each participant for each 6-month period, and divided by the number of days in the relevant six month period to arrive at a TSDD. Range: The minimum possible value is 0 (optimal outcome; indicating zero exposure to ACB 2 or 3 medications). There is no fixed theoretical maximum score(higher value more exposure), as the upper limit is mathematically determined by the total volume and combination of medications a participant is prescribed.
Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records
时间窗: Baseline, 6, and 12 Months
Construct: Measures natural log-transformed average daily exposure to medications with an Anticholinergic Cognitive Burden (ACB) score of 2 or 3 to normalize data distribution.How Computed: Medication Standardized Daily Dose (SDD) = (strength × units/dose × frequency/day × refills) / minimum effective daily or geriatric dose. The SDD for all eligible drugs is summed over 6 months, divided by the number of days in that period to find raw TSDD, and natural log-transformed ($\\ln(x+1)$ or similar) for the final score.Scale Range: Minimum value is 0 (representing 0 raw TSDD, or zero exposure). There is no fixed theoretical maximum, as it is mathematically determined by the volume of medications prescribed.Interpretation: A value of 0 is the optimal outcome (no exposure). Higher values represent greater exposure (worse outcome).
次要结局
- Overall Cognitive Score(Baseline, 6 months, and 12 months)
- Choice Reaction Time (CRT)(Baseline)
- Health Utilities Index (HUI) Mark 3(Baseline, 6 months, and 12 months)
- Hopkins Verbal Learning Test (HVLT) Total Recall(Baseline, 6 months, and 12 months)
- Hopkins Verbal Learning Test (HVLT) Delayed Recall(Baseline, 6 months, 12 months)
- Trail Making Test (TMT) Parts A(Baseline, 6 months, and 12 months)
- Trail Making Test (TMT) Parts B(Baseline, 6 months, and 12 months)
- Digit-Symbol Substitution Test (DSST) Number of Correct Responses(Baseline, 6 months, and 12 months)
研究者
Richard Holden
Associate Professor, Indiana University School of Medicine Chief Healthcare Engineer, Center for Health Innovation and Implementation Science
Indiana University