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临床试验/NCT07016178
NCT07016178已完成不适用

Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research

Indiana University1 个研究点 分布在 1 个国家目标入组 3,454 人开始时间: 2025年10月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,454
试验地点
1
主要终点
Implementation of the PDM to identify at risk patients

研究概览

简要总结

Recent studies have highlighted the potential use of electronic health record (EHR) data for scalable and less biased identification of people who may have or be at risk of developing MCI or ADRD at the population level.8,9 Using data from the EHR in advance of PC visits can systematically identify patients with undetected MCI and ADRD. At Indiana University (IU), researchers developed a Passive Digital Marker (PDM) to enable early detection of ADRD with an 80% accuracy for one-year and three-year prediction horizons.8,9 Despite the accuracy of the PDM, the feasibility, acceptability, and overall effectiveness of its use for early detection of ADRD in PC remains unclear.

Building on this innovative tool and the ongoing engagement in IUH PC for early detection of ADRD, we propose a project to test the acceptability and feasibility of implementing the PDM in IUH PC to identify people with and at risk of MCI and ADRD and measure if we can increase patient engagement in research and evidence-based follow-up care with the IUH Brain Health Navigator (BHN). The BHN, is primary care based registered nurse with special training to conduct additional assessments of patients following a positive ADRD screen to identify possible underlying causes of cognitive impairment and assist the PCP to facilitate the patient's next steps for diagnostic assessment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •65 years and older; established patients of 12 selected clinics at IU Health PC who are identified by the PDM as high risk for developing or having undetected MCI or ADRD.

排除标准

  • •Patients younger than 65 years; Patients with less than 2 years of available EHR data; individuals whose primary language is not English; and current diagnosis of ADRD or MCI; and current diagnosis of bipolar disorder or schizophrenia.

研究组 & 干预措施

PDM+

Experimental

Patients at participating clinics identified through the Passive Digital Marker (PDM) as at risk will be contacted for clinical follow up via Twistle, a secure text message platform prior to their next schedule primary care visit. Patients identified as at risk, PDM+, who confirm a cognitive concern via Twistle will be referred to the IU Health Brain Health Navigator (BHN), a clinical nurse embedded in primary care. . The BHN will deliver the IUH Brain Health Protocol to assess for reversible causes, initiate shared decision-making processes for care and treatment, assess for treatment eligibility, and complete a warm hand-off when appropriate. Additionally, the BHN will facilitate patient enrollment in the Indiana CTSI ALL IN research registry and/or the IU Biobank.

干预措施: Acceptability and Feasibility of Twistle messaging for PDM+ patients (Behavioral)

结局指标

主要结局

Implementation of the PDM to identify at risk patients

时间窗: 3 months post index visit

Implement the PDM, using IUH EHR data, to identify primary care patients aged 65 or older who a have undetected MCI or ADRD or who are at risk. Measured by the number of patients identified as high-risk by the PDM.

2.1 Effectiveness of Patient-informed messaging

时间窗: 3 months post index visit

Evaluate the effectiveness of the patient-informed message using IUH's patient facing application, Twistle, in engaging PDM positive patients to complete a cognitive assessment with the BHN as measured by the percentage of patients who open the message.

2.2 Effectiveness of Patient-informed messaging

时间窗: 3 months post index visit

Evaluate the effectiveness of the patient-informed message using IUH's patient facing application, Twistle, in engaging PDM positive patients to complete a cognitive assessment with the BHN as measured by the percentage that engage with the message.

2.3 Effectiveness of Patient-informed messaging

时间窗: 3 months post index visit

Evaluate the effectiveness of the patient-informed message using IUH's patient facing application, Twistle, in engaging PDM positive patients to complete a cognitive assessment with the BHN as measured by the percentage of patients who answer the Subjective Cognitive Concerns questions.

2.4 Effectiveness of Patient-informed messaging

时间窗: 3 months post index visit

Evaluate the effectiveness of the patient-informed message using IUH's patient facing application, Twistle, in engaging PDM positive patients to complete a cognitive assessment with the BHN as measured by the percentage of patients who schedule a BHN appointment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole R. Fowler, PhD

Scientist, Indiana University Center for Aging Research

Indiana University

研究点 (1)

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