DementiaNCT03569722
EpxCogScreen -- A Phone-based Rapid Cognitive Screen (RCS)
An observational study of Dementia and Telemedicine, run by Theodore Malmstrom, PhD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Telemedicine, Cognitive Dysfunction
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2018to 2 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients under the age of 65
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis University Geriatric Clinic
St Louis, Missouri, 63014
About this study
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.
Read the 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.
- Conditions
- Dementia, Telemedicine, Cognitive Dysfunction
- Keywords
- Cognitive screen
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older adults | Older adults, ages 65+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Cognitive Screen Scores
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).
Measured: 1 month
Secondary outcomes (1)
Clinical diagnosis of cognitive dysfunction (where available from medical records) will be compared to Rapid Cognitive Screen scores done at home via telemedicine
Diagnosis of mild cognitive impairment or dementia in medical records
Measured: Previous clinical diagnosis cognitive dysfunction documented in medical records up to 36 months prior to Rapid Cognitive Screen scores done at home via telemedicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start21 Nov 2018
- Primary completion2 Jan 2019
- Study completion2 Jan 2019
Why it stopped: This study was terminated due to insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodore Malmstrom, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theodore Malmstrom, PhD, St. Louis University
- Investigators
- Theodore K Malmstrom, PhD, Principal investigator, Saint Louis Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569722
- Sponsor's protocol ID
- 27943
- Status last verified
- Jan 2019
- First submitted
- 11 May 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van der Linde RM, Dening T, Stephan BC, Prina AM, Evans E, Brayne C. Longitudinal course of behavioural and psychological symptoms of dementia: systematic review. Br J Psychiatry. 2016 Nov;209(5):366-377. doi: 10.1192/bjp.bp.114.148403. Epub 2016 Aug 4.
PubMed 27491532Cordell CB, Borson S, Boustani M, Chodosh J, Reuben D, Verghese J, Thies W, Fried LB; Medicare Detection of Cognitive Impairment Workgroup. Alzheimer's Association recommendations for operationalizing the detection of cognitive impairment during the Medicare Annual Wellness Visit in a primary care setting. Alzheimers Dement. 2013 Mar;9(2):141-50. doi: 10.1016/j.jalz.2012.09.011. Epub 2012 Dec 20.
PubMed 23265826Malmstrom TK, Voss VB, Cruz-Oliver DM, Cummings-Vaughn LA, Tumosa N, Grossberg GT, Morley JE. The Rapid Cognitive Screen (RCS): A Point-of-Care Screening for Dementia and Mild Cognitive Impairment. J Nutr Health Aging. 2015 Aug;19(7):741-4. doi: 10.1007/s12603-015-0564-2.
PubMed 26193857Dubois B, Padovani A, Scheltens P, Rossi A, Dell'Agnello G. Timely Diagnosis for Alzheimer's Disease: A Literature Review on Benefits and Challenges. J Alzheimers Dis. 2016;49(3):617-31. doi: 10.3233/JAD-150692.
PubMed 26484931Weimer DL, Sager MA. Early identification and treatment of Alzheimer's disease: social and fiscal outcomes. Alzheimers Dement. 2009 May;5(3):215-26. doi: 10.1016/j.jalz.2009.01.028. Epub 2009 Apr 11.
PubMed 19362885Lin JS, O'Connor E, Rossom RC, Perdue LA, Eckstrom E. Screening for cognitive impairment in older adults: A systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 Nov 5;159(9):601-12. doi: 10.7326/0003-4819-159-9-201311050-00730.
PubMed 24145578
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpxCogScreen -- A Phone-based Rapid Cognitive Screen (RCS)
- ClinicalTrials.gov ID
- NCT03569722
- Acronym / sponsor ID
- 27943
- Conditions
- Dementia, Telemedicine, Cognitive Dysfunction
- Keywords
- Cognitive screen
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated due to insufficient recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Theodore Malmstrom, PhDUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults | – | –Older adults, ages 65+ |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients under the age of 65
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
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
Results and safety
The study was stopped early (reason given: This study was terminated due to insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 27491532van der Linde RM, Dening T, Stephan BC, Prina AM, Evans E, Brayne C. Longitudinal course of behavioural and psychological symptoms of dementia: systematic review. Br J Psychiatry. 2016 Nov;209(5):366-377. doi: 10.1192/bjp.bp.114.148403. Epub 2016 Aug 4.
- Background: PubMed 23265826Cordell CB, Borson S, Boustani M, Chodosh J, Reuben D, Verghese J, Thies W, Fried LB; Medicare Detection of Cognitive Impairment Workgroup. Alzheimer's Association recommendations for operationalizing the detection of cognitive impairment during the Medicare Annual Wellness Visit in a primary care setting. Alzheimers Dement. 2013 Mar;9(2):141-50. doi: 10.1016/j.jalz.2012.09.011. Epub 2012 Dec 20.
- Background: PubMed 26193857Malmstrom TK, Voss VB, Cruz-Oliver DM, Cummings-Vaughn LA, Tumosa N, Grossberg GT, Morley JE. The Rapid Cognitive Screen (RCS): A Point-of-Care Screening for Dementia and Mild Cognitive Impairment. J Nutr Health Aging. 2015 Aug;19(7):741-4. doi: 10.1007/s12603-015-0564-2.
- Background: PubMed 26484931Dubois B, Padovani A, Scheltens P, Rossi A, Dell'Agnello G. Timely Diagnosis for Alzheimer's Disease: A Literature Review on Benefits and Challenges. J Alzheimers Dis. 2016;49(3):617-31. doi: 10.3233/JAD-150692.
- Background: PubMed 19362885Weimer DL, Sager MA. Early identification and treatment of Alzheimer's disease: social and fiscal outcomes. Alzheimers Dement. 2009 May;5(3):215-26. doi: 10.1016/j.jalz.2009.01.028. Epub 2009 Apr 11.
- Background: PubMed 24145578Lin JS, O'Connor E, Rossom RC, Perdue LA, Eckstrom E. Screening for cognitive impairment in older adults: A systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 Nov 5;159(9):601-12. doi: 10.7326/0003-4819-159-9-201311050-00730.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore K Malmstrom, PhD principal investigator
Saint Louis Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Telemedicine, run by Theodore Malmstrom, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was terminated due to insufficient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Cognitive Screen Scores (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569722, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.