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

January 31, 2019 updated by: Theodore Malmstrom, PhD
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.

Study Overview

Status

Terminated

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63014
        • Saint Louis University Geriatric Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population used will include all genders, socioeconomic, and ethnic backgrounds. Patients with (mild cognitive impairment, dementia) and without (normal cognition) a diagnosis of cognitive dysfunction will be included in the study. Geriatric patients (>65 years old) will be included in the study, but recruited caregivers must be over the age of 18.

Description

Inclusion Criteria:

  • Patients must be >65 years old
  • Patients must have a caregiver or family member who can administer the intervention at home
  • Caregivers must be between 18-90 years old
  • Caregivers must have a working cellular device with SMS texting capabilities
  • Both patients and caregivers must speak English

Exclusion Criteria:

  • Patients under the age of 65

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Older adults
Older adults, ages 65+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid Cognitive Screen Scores
Time Frame: 1 month
Rapid Cognitive Screen scores with be done at home via telemedicine approximately 30 days after being done at a clinic visit. Scores range on a scale of 0-10. Scores will also be subdivided into the categories of free recall (5 points), clock drawing (4 points) and insight (1 point); and based on classification on the RCS (normal cognitive function, mild cognitive impairment [MCI], dementia).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical diagnosis of cognitive dysfunction (where available from medical records) will be compared to Rapid Cognitive Screen scores done at home via telemedicine
Time Frame: Previous clinical diagnosis cognitive dysfunction documented in medical records up to 36 months prior to Rapid Cognitive Screen scores done at home via telemedicine
Diagnosis of mild cognitive impairment or dementia in medical records
Previous clinical diagnosis cognitive dysfunction documented in medical records up to 36 months prior to Rapid Cognitive Screen scores done at home via telemedicine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theodore Malmstrom, PhD

Investigators

  • Principal Investigator: Theodore K Malmstrom, PhD, Saint Louis Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2018

Primary Completion (Actual)

January 2, 2019

Study Completion (Actual)

January 2, 2019

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27943

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Dysfunction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe