Knowledge TranslationCognitnECHONCT05471141
Preventing and Managing Cognitive Impairment
A study testing Cognition ECHO in people with Knowledge Translation and Cognitive Impairment, run by Charles Drew University of Medicine and Science.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Knowledge Translation, Cognitive Impairment
- What is being tested?
- Cognition ECHO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Mar 2023to 28 Feb 2024
- Phase
- Interventional
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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
- Being tested
- Cognition ECHO
- Keywords
- primary health care, cognitive impairment, translational science, translational research, general practitioners, Minority Health
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognition ECHOOther
Also called Tele-mentoring with (1) a didactic presentation and (2) de-identified discussion by a panel with experts, a patient, and a family member.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Cognition ECHO |
| Group 2 | No intervention | To serve as the control during phase 1 and receive intervention during the phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 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:
- 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
Measured: 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:
- 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
Measured: 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:
- 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
Measured: 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:
- 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Evidence of CMTs in clinical encounter notes will be explored using artificial intelligence, natural language processing (NLP) method. It is a machine learning process for the project team to develop the list of words and phrases related to CMTs to be included in machine learning and to perform the search, to extract, organize, and aggregate evidence of CMTs embedded in the de-identified clinic encounter notes.
Measured: the baseline two -identified clinic encounter notes: Baseline (30 days). Post-intervention (30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start13 Mar 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Why it stopped: Difficulty obtaining IRB approval from all sites with challenges in recruitment. No participants enrolled. So, we revised the study. Now it does not meet the NIH or FDA's definition of clinical trials. We request to close this registration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge TranslationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan-Pin C Fanchiang, Ph.D., Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471141
- Sponsor's protocol ID
- 1931012
- Acronym
- CognitnECHO
- Status last verified
- Feb 2024
- First submitted
- 30 Jun 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Study Protocol and the Clinical Study Report.
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing and Managing Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05471141
- Acronym / sponsor ID
- CognitnECHO / 1931012
- Conditions
- Knowledge Translation, Cognitive Impairment
- Keywords
- primary health care, cognitive impairment, translational science, translational research, general practitioners, Minority Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty obtaining IRB approval from all sites with challenges in recruitment. No participants enrolled. So, we revised the study. Now it does not meet the NIH or FDA's definition of clinical trials. We request to close this registration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 13 Mar 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 22 Jul 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Cognition ECHOTo 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 |
| Group 2 | No intervention | –To serve as the control during phase 1 and receive intervention during the phase 2 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognition ECHOAlso: Tele-mentoring with (1) a didactic presentation and (2) de-identified discussion by a panel with experts, a patient, and a family member.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. | Other | Group 1 |
Primary outcome
Estimated adherence1
Time frame: 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.
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.
Estimated adherence2
Time frame: 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.
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
Estimated adherence3
Time frame: 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.
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
Estimated adherence4
Time frame: 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.
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
Estimated adherence5
Time frame: 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 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 "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 1
Time frame: Week 4 to Week 8, Baseline.
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 "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 2
Time frame: The 2nd day of Week 22 to the end of Week 25
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 "System Usability Scale of Cognition Management Tasks" (SUS CMTs) - 3
Time frame: The 2nd day of Week 41 to the end of Week 44
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 "Self-Efficacy of Cognition Management Tasks" - 1
Time frame: The 2nd day of Week 22 to the end of Week 25
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 "Self-Efficacy of Cognition Management Tasks" - 2
Time frame: The 2nd day of Week 41 to the end of Week 44
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.
1 secondary outcome
Changes seen through the evidence of cognition management tasks in clinical encounter notes
Time frame: the baseline two -identified clinic encounter notes: Baseline (30 days). Post-intervention (30 days).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Yes. The Study Protocol and the Clinical Study Report.
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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.
Shan-Pin C Fanchiang, Ph.D. principal investigator
Charles Drew University of Medicine and Science
Questions about this trial
What is this clinical trial studying?
A study testing Cognition ECHO in people with Knowledge Translation and Cognitive Impairment, run by Charles Drew University of Medicine and Science.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Estimated adherence1 (time frame: 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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Feb 2024.