EpxCogScreen -- A Phone-based Rapid Cognitive Screen (RCS)

Dementia Clinical Trial

Official title: EpxCogScreen -- A Phone-based Rapid Cognitive Screen (RCS)

Status Terminated

Clinical Trial Summary

EpxCogScreen is a phone-based intervention to administer the Rapid Cognitive Screen, a validated screening tool for dementia, over SMS text messaging. The results of the screen are sent to the physician automatically, which allows physicians to monitor their patients and gives them the ability to respond rapidly to any concerns of cognitive decline. In this study, patients' at-home RCS scores done by EpxCogScreen will be compared to their in-clinic RCS scores, and to clinical diagnosis of dementia (where available), to investigate the validity of EpxCogScreen.

Clinical Trial Description

Telemedicine is a modern field of clinical medicine that incorporates telecommunication and information technology to diagnose and manage health care remotely. Interventions range from telephone reminders to remote physician consultation by video conference. Simple technology such as telephones and SMS texting are ubiquitous forms of communication that have the potential to increase the frequency of physician-patient contact. Use of SMS messaging, for example, may help to improve patient adherence, promote education and engagement, allow real-time collection of critical biometric and clinical data over time, and bridge the gap between recognizing adverse events and actual disease management.

One geriatric syndrome that may benefit from early detection is dementia. Dementia is characterized by impairments in cognitive function, such as memory, comprehension, visual-spatial orientation, language, and/or judgement. The most common form of dementia is Alzheimer's disease, but vascular dementia and Lewy-body dementia can also cause cognitive impairment. It is estimated that 47.5 million people are affected with dementia worldwide and it is the most common form of disability in the geriatric population over the age of 65, affecting 1 in 9 people in that population [van der Linde, et al., 2016]. A formal diagnosis for Alzheimer's relies primarily on clinical evaluation by a clinician (e.g., neurologist, psychiatrist), usually in conjunction with results from neuropsychological testing and/or informant reports re patients' memory and thinking.

In 2011, the Affordable Care Act added routine cognitive screening as a component of the Medicare Annual Wellness Visit, but did not recommend a universal screening tool [Cordell et al., 2012]. This initiative was supported by many public organizations, including the Alzheimer's Association. The U.S. Preventative Services Task Force (USPSTF) currently does not recommend universal cognitive screening for older adults [Lin et al., 2013]. Nonetheless, there may be benefits to case finding among older adults patients through the use of screening measures. For example, early intervention has been shown to delay placement into nursing homes, empower patients to be more involved with their care plan, and allow physicians to identify and manage comorbidities such as depression, malnutrition, and falls more effectively [Dubois et al., 2016; Weimer et al., 2009]. Delayed admission into nursing homes and fewer hospitalizations are associated with decreased healthcare costs for patients, their families, and the healthcare system [Weimer et al., 2009]. It also has been reported that a lot of Alzheimer's patients are undiagnosed, in part, because screening has not yet reached standard-of-practice in geriatric and primary care clinics [Dubois et al., 2016].

Healthcare professionals may not be able to regularly screen for cognitive dysfunction due to time constraints in clinical practice. Typical neuropsychological tests for cognitive dysfunction, such as the Mini-Mental State Exam (MMSE), are administered in the physician's office and can take 7 to 15 minutes to complete. The Rapid Cognitive Screen (RCS) is a 3-item screening tool that takes less than 5 minutes to complete. This screen has exhibited good sensitivity and specificity in detecting both mild cognitive impairment and dementia in patients over the age of 65 [Malmstrom et al., 2015]. EpxCogScreen utilizes the RCS to create a phone-based screen for cognitive dysfunction that can be done in-home when administered by a caregiver.

In this study, the RCS will be administered in a healthcare clinic using standard procedures, and at home using a telemedicine (text-based) format called EpxCogScreen. Patients-caregiver dyads will be recruited from a geriatric medicine clinic at an academic medical health center. A healthcare professional will administer the RCS to a patient in the clinic, one month subsequent to this, a caregiver will administer the RCS to patients in-home via EpxCogScreen using SMS messaging on a smartphone. Each caregiver will be given the option to receive RCS administration instructions via text, or to use directions from a handout that the caregiver received while in clinic. Patient responses will be recorded through text. Physicians will be notified immediately through EpxCogScreen system if a patients in-home RCS score is 3 or more points lower than their RCS score from the previous month's healthcare clinic visit. Individuals will have the ability to opt out of the study electronically via text and phone at any point during the study.

The association of in-home RCS scores with the clinic RCS scores and with the clinical diagnosis of cognitive dysfunction in medical records will be investigated in this study. Data analysis will evaluate the association of RCS components (recall, clock drawing, insight) and total scores for in-home versus clinic measurements; and the sensitivity and specificity of the in-home, SMS text-based RCS will be determined by comparison to clinical diagnosis of cognitive dysfunction from chart review, and by comparison to RCS clinic results. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Telemedicine

• NCT number: NCT03569722
• Study type: Observational
• Source: St. Louis University
• Status: Terminated
• Start date: November 21, 2018
• Completion date: January 2, 2019