Clinical trial NCT05471141: Preventing and Managing Cognitive Impairment
Official title: Preventing and Managing Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knowledge Translation
Cognitive Impairment
Keywords: primary health care
cognitive impairment
translational science
translational research
general practitioners
Minority Health
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 will receive the intervention Cognition ECHO during Phase 1 and Group 2 will serve as the control. About one month after Group 1 has completed the attendance of all five sessions of Cognition ECHO, Group 2 will start receiving the intervention Cognition ECHO and Group 1 will wait for the follow-up till Week 41 of the study in November 2023.
Primary purpose: OTHER

Brief summary: This randomized controlled trial (RCT) is used to address the knowledge translation of primary care practitioners (PCPs) for the early identification of cognitive impairment. Cognitive impairment is experienced by people with many different underlying health problems, e.g., diabetes, cardiovascular problems, COVID-19, neurodegenerative diseases, and mental health problems. Older adults are more likely to have cognitive decline which may develop into Alzheimer's disease or dementia but 40% of dementia can be prevented by managing the risks. Cognitive impairment can demand vast societal resources, the burden is reported to be more among Hispanics and blacks. By 2029, all baby boomers will be over 65, comprising at least 20% of the U.S. population. So, it is critical for PCPs to effectively identify, prevent, and manage the hidden signs of cognitive impairment. People with early signs of cognitive impairment will have opportunities to benefit from suitable cognitive remediation to reverse it or prevent rapid progression. It is critically important for people who are socioeconomically disadvantaged, those who are black, indigenous, and people of color (BIPoC). These people are often served by safety-net hospitals, such as clinics of the Los Angeles County (LAC) Department of Health Services and the federally qualified health centers at the Community Clinics Association of LAC. Many PCPs in these clinics are often BIPoC. The intervention used in this RCT is called "Cognition ECHO" based on the proven model of ECHO (Extension of Healthcare Outcomes) for knowledge dissemination and translation. Cognition ECHO is a virtual activity incorporating a short didactic presentation and de-identified case discussion to solve real-world patient care challenges and ease direct knowledge translation. PCPs in the LAC will be randomized into Groups 1 and 2. Group 1 will attend the five Cognition ECHO for four months, Group 2 will be the control. Group 2 will attend Cognition ECHO starting on July 25, 2023, five times till November 7, 2023, when Group 1 is the follow-up. Most sessions are scheduled on the fourth Tuesday of the month with the addition of June 6 and November 7, 2023. Focusing on cognitive impairment and targeting PCPs at the LAC, the goal of this study is to evaluate if Cognition ECHO can improve PCPs' capacity to detect early cognitive impairment and manage it. It will result in opportunities to mitigate the risk factors of early cognitive impairment, especially for minority patients in LAC, and conduct efficacy studies in the future to address cognitive impairment focusing on BIPoC.


Eligibility criteria: Inclusion Criteria:

1. Primary care practitioner (i.e. physician, NP or PA) at least 21-year-old.
2. Spending at least 40% of the work hours in patient care with adult patients currently.
3. Self-identifying being comfortable to attend virtual learning sessions using their own smartphones, laptops/desktop computers, or mobile devices in their work setting.
4. Willingness to send in a total of four electronic copies (in WORD) of de-identified clinic notes written documenting the initial encounters of patients with poorly controlled type 2 diabetes (A1c \>= 8%) or any patients with early signs of neurodegenerative diseases, Alzheimer's diseases or other conditions that may affect the cognition.

Exclusion Criteria:

* Do not work at least 40% of the week for care provision in primary care
* Do not work in the outpatient clinics of the Los Angeles County (LAC) Department of Health Services (DHS) and member clinics of the Community Clinics of the Los Angeles County (CCALAC) with the federally qualified health centers (FQHCs).

Primary outcomes:
measure: Estimated adherence1
timeFrame: The 2nd day of Week 9 to the end of Week 9 for Group 1. The 2nd day of Week 26 to the end of Week 26 for Group 2.
measure: Estimated adherence2
timeFrame: The 2nd day of Week 13 to the end of Week 13 for Group 1; the 2nd day of Week 30 to the end of Week 30 for Group 2.
measure: Estimated adherence3
timeFrame: The 2nd day of Week 17 to the end of Week 17 for Group 1; the 2nd day of Week 35 to the end of Week 35 for Group 2.
measure: Estimated adherence4
timeFrame: The 2nd day of Week 19 to the end of Week 19 for Group 1; the 2nd day of Week 39 to the end of Week 39 for Group 2.
measure: Estimated adherence5
timeFrame: The 2nd day of Week 22 to the end of Week 22 for Group 1; the 2nd day of Week 41 to the end of Week 41 for Group 2.
measure: The "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 1
timeFrame: Week 4 to Week 8, Baseline.
measure: The "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 2
timeFrame: The 2nd day of Week 22 to the end of Week 25
measure: The "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 3
timeFrame: The 2nd day of Week 41 to the end of Week 44
measure: The "Self-Efficacy of Cognition Management Tasks" - 1
timeFrame: The 2nd day of Week 22 to the end of Week 25
measure: The "Self-Efficacy of Cognition Management Tasks" - 2
timeFrame: The 2nd day of Week 41 to the end of Week 44
Secondary outcomes:
measure: Changes seen through the evidence of cognition management tasks in clinical encounter notes
timeFrame: the baseline two -identified clinic encounter notes: Baseline (30 days). Post-intervention (30 days).
Other outcomes:
Locations:
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Shan-Pin C Fanchiang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: