RECRUITING

5-Cog 2.0: A Pragmatic Clinical Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. This problem is more prevalent in health disparities populations. The investigators developed the 5-Cog brief cognitive assessment that is simple to use, standardized, takes \<5 minutes, does not require informants, and accounts for major technical, cultural, and logistical barriers of current assessments. The investigators propose a hybrid Type 1 effectiveness-implementation design in real-world settings to adapt and test the effectiveness of the 5-Cog paradigm to increase detection of cognitive impairment care in older adults presenting with cognitive concerns. The study aim is to evaluate, using a pragmatic cluster-randomized trial design, the effectiveness of the 5-Cog paradigm to increase 'incident cognitive impairment' detection (new MCI and dementia diagnoses) relative to enhanced usual care in 6,600 older patients presenting with cognitive concerns in 22 primary care clinics in Bronx and Indiana. As diagnosis without action will not improve patient care, 'improved dementia care' will be examined as a secondary outcome. Results will also be examined in NIH designated health disparity populations including underserved minority and socio-economically challenged populations.

Official Title

5-Cog Paradigm to Improve Detection of Cognitive Impairment in Primary Care: Pragmatic Clinical Trial

Quick Facts

Study Start:2023-08-18
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05515224

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.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 65 years and older
  2. 2. Presence of cognitive concerns
  1. 1. Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians).
  2. 2. Permanent nursing facility residents.

Contacts and Locations

Study Contact

Emmeline Ayers, MPH
CONTACT
718-430-3835
emmeline.ayers@einsteinmed.edu
Erica Weiss, PhD
CONTACT
EWEISS@montefiore.org

Principal Investigator

Joe Verghese, MD
PRINCIPAL_INVESTIGATOR
Stony Brook University
Malaz Boustani, MD, MPH
PRINCIPAL_INVESTIGATOR
Indiana University
Erica Weiss, PhD
PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicie

Study Locations (Sites)

Indiana University
Bloomington, Indiana, 47405
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

  • Joe Verghese, MD, PRINCIPAL_INVESTIGATOR, Stony Brook University
  • Malaz Boustani, MD, MPH, PRINCIPAL_INVESTIGATOR, Indiana University
  • Erica Weiss, PhD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicie

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 Registration Dates

Study Start Date2023-08-18
Study Completion Date2027-11

Study Record Updates

Study Start Date2023-08-18
Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

  • Dementia
  • Cognitive Impairment