Preventing and Managing Cognitive Impairment

NCT05471141 | Withdrawn

• 1 other identifier: 1931012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knowledge Translation; Cognitive Impairment

Keywords

primary health care; cognitive impairment; translational science; translational research; general practitioners; Minority Health

Outcome Measures

Primary Outcomes (10)

• Estimated adherence1

  The ETAC (Empowered-To-Act Consistently) scale is used to measure the estimated adherence. The categories are to guide learners' reflection on their future actions, not measuring change. Four ETAC questions are designed for the four cognition management tasks to be included in a post-session evaluation of a Cognition ECHO session. Using the ETAC scale, the reasons and concerns of the option selected can be explored qualitatively. The ETAC scale has six levels: A) I will not do it; because: \_. B) I will think about it, because: \_. C) I will think about ways to help me start doing it, specific areas: \_ . D) I'll start doing it from now on, areas to start: \_. E) I've done some but can still do more, areas to do more: \_. F) I am doing it as much as I can. No new actions are needed; sharing your successful experience: \_. The percentages of those picked options C, D, and E will be used in this study as estimated adherence for each session of the Cognition ECHO.

  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.

• Estimated adherence2

  The ETAC (Empowered-To-Act Consistently) scale is used to measure the estimated adherence. The categories are to guide learners' reflection on their future actions, not measuring change. Four ETAC questions are designed for the four cognition management tasks to be included in a post-session evaluation of a Cognition ECHO session. Using the ETAC scale, the reasons and concerns of the option selected can be explored qualitatively. The ETAC scale has six levels: A) I will not do it; because: \_. B) I will think about it, because: \_. C) I will think about ways to help me start doing it, specific areas: \_ . D) I'll start doing it from now on, areas to start: \_. E) I've done some but can still do more, areas to do more: \_. F) I am doing it as much as I can. No new actions are needed; sharing your successful experience: \_. The percentages of those picked options C, D, and E will be used in this study as estimated adherence for each session of the Cognition ECHO

  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.

• Estimated adherence3

  The ETAC (Empowered-To-Act Consistently) scale is used to measure the estimated adherence. The categories are to guide learners' reflection on their future actions, not measuring change. Four ETAC questions are designed for the four cognition management tasks to be included in a post-session evaluation of a Cognition ECHO session. Using the ETAC scale, the reasons and concerns of the option selected can be explored qualitatively. The ETAC scale has six levels: A) I will not do it; because: \_. B) I will think about it, because: \_. C) I will think about ways to help me start doing it, specific areas: \_ . D) I'll start doing it from now on, areas to start: \_. E) I've done some but can still do more, areas to do more: \_. F) I am doing it as much as I can. No new actions are needed; sharing your successful experience: \_. The percentages of those picked options C, D, and E will be used in this study as estimated adherence for each session of the Cognition ECHO

  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.

• Estimated adherence4

  The ETAC (Empowered-To-Act Consistently) scale is used to measure the estimated adherence. The categories are to guide learners' reflection on their future actions, not measuring change. Four ETAC questions are designed for the four cognition management tasks to be included in a post-session evaluation of a Cognition ECHO session. Using the ETAC scale, the reasons and concerns of the option selected can be explored qualitatively. The ETAC scale has six levels: A) I will not do it; because: \_. B) I will think about it, because: \_. C) I will think about ways to help me start doing it, specific areas: \_ . D) I'll start doing it from now on, areas to start: \_. E) I've done some but can still do more, areas to do more: \_. F) I am doing it as much as I can. No new actions are needed; sharing your successful experience: \_. The percentages of those picked options C, D, and E will be used in this study as estimated adherence for each session of the Cognition ECHO

  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.

• Estimated adherence5

  The ETAC (Empowered-To-Act Consistently) scale is used to measure the estimated adherence. The categories are to guide learners' reflection on their future actions, not measuring change. Four ETAC questions are designed for the four cognition management tasks to be included in a post-session evaluation of a Cognition ECHO session. Using the ETAC scale, the reasons and concerns of the option selected can be explored qualitatively. The ETAC scale has six levels: A) I will not do it; because: \_. B) I will think about it, because: \_. C) I will think about ways to help me start doing it, specific areas: \_ . D) I'll start doing it from now on, areas to start: \_. E) I've done some but can still do more, areas to do more: \_. F) I am doing it as much as I can. No new actions are needed; sharing your successful experience: \_. The percentages of those picked options C, D, and E will be used in this study as estimated adherence for each session of the Cognition ECHO

  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.

• The "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 1

  The System Usability Scales of Cognitive Management Tasks (SUS CMTs) are adapted from the standardized measure, System Usability Scale. Each scale has ten items and a five-point scale ranging from "strongly disagree" to "strongly agree." The final score ranges from 0 to 100. A high score indicates high usability. The SUS CMTs are used to measure the perceived usability of the cognitive management tasks.

  Week 4 to Week 8, Baseline.

• The "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 2

  The System Usability Scales of Cognitive Management Tasks (SUS CMTs) are adapted from the standardized measure, System Usability Scale. Each scale has ten items and a five-point scale ranging from "strongly disagree" to "strongly agree." The final score ranges from 0 to 100. A high score indicates high usability. The SUS CMTs are used to measure the perceived usability of the cognitive management tasks.

  The 2nd day of Week 22 to the end of Week 25

• The "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 3

  The System Usability Scales of Cognitive Management Tasks (SUS CMTs) are adapted from the standardized measure, System Usability Scale. Each scale has ten items and a five-point scale ranging from "strongly disagree" to "strongly agree." The final score ranges from 0 to 100. A high score indicates high usability. The SUS CMTs are used to measure the perceived usability of the cognitive management tasks.

  The 2nd day of Week 41 to the end of Week 44

• The "Self-Efficacy of Cognition Management Tasks" - 1

  The Self-Efficacy of Cognition Management Tasks (CMTs) is a survey adapted from a self-efficacy scale for primary care practitioners to evaluate their self-efficacy in diabetes care provision (Bouchonville et al., 2018). The Self-Efficacy of CMTs measures the capacity of PCPs to do these cognition management tasks. It is a survey with ten items using a seven-point scale ranging from "none, no skills" to "expert, teaching others." The final score ranges from 10 to 70 with a high score reflecting better self-efficacy. The items reflect the knowledge and skills most relevant to detecting and managing cognitive impairment by primary care practitioners. With the adjustment to address response shift bias, the retrospective pre-intervention status will be compared together.

  The 2nd day of Week 22 to the end of Week 25

• The "Self-Efficacy of Cognition Management Tasks" - 2

  The Self-Efficacy of Cognition Management Tasks (CMTs) is a survey adapted from a self-efficacy scale for primary care practitioners to evaluate their self-efficacy in diabetes care provision (Bouchonville et al., 2018). The Self-Efficacy of CMTs measures the capacity of PCPs to do these cognition management tasks. It is a survey with ten items using a seven-point scale ranging from "none, no skills" to "expert, teaching others." The final score ranges from 10 to 70 with a high score reflecting better self-efficacy. The items reflect the knowledge and skills most relevant to detecting and managing cognitive impairment by primary care practitioners. With the adjustment to address response shift bias, the retrospective pre-intervention status will be compared together.

  The 2nd day of Week 41 to the end of Week 44

Secondary Outcomes (1)

• Changes seen through the evidence of cognition management tasks in clinical encounter notes

  the baseline two -identified clinic encounter notes: Baseline (30 days). Post-intervention (30 days).

Study Arms (2)

Group 1

EXPERIMENTAL

To receive intervention during the phase 1 and will receive nothing during the phase 2, will complete the measure at the end of phase 2 as the follow-up

Other: Cognition ECHO

Group 2

NO INTERVENTION

To serve as the control during phase 1 and receive intervention during the phase 2

Interventions

Cognition ECHO OTHER

Cognition ECHO is the intervention designed to be used by the study participants who are primary care practitioners. No involvement of patients in this study. The panel will consist of the CI and Co-PIs of this study, a neurologist as a co-moderator, a medical specialist who is the expert on the subject, an occupational therapist, a psychologist, and a speech and language pathologist with experience and expertise in CI. A patient with CI and a caregiver, family member, or community representative who is not a healthcare professional will join the panel because CI is frequently observed with lived experience of family members and loved ones, as two non-clinician panelists. The five topics with the integration of related diagnoses for Cognition ECHO are listed in Table 4. The time allocated for the didactic will be 15-20 minutes and the de-identified case discussion will be 40 - 45 minutes.

Also known as: Tele-mentoring with (1) a didactic presentation and (2) de-identified discussion by a panel with experts, a patient, and a family member.

Group 1

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care practitioner (i.e. physician, NP or PA) at least 21-year-old.
• Spending at least 40% of the work hours in patient care with adult patients currently.
• Self-identifying being comfortable to attend virtual learning sessions using their own smartphones, laptops/desktop computers, or mobile devices in their work setting.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Shan-Pin C Fanchiang, Ph.D.

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will be informed that they will receive intervention but one group starts first and the other group will start with a 4-month delay.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 22, 2022
• Study Start: March 13, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Both items will be available to share from January 5, 2025, to June 30, 2025.
• Access Criteria: By sending an email request to the PI, shanpinfanchiang@cdrewu.edu.