Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AG072153 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
The overarching goal of this study is to a) assess the feasibility and preliminary validity of home-based delivery of TeleNP to patients with suspected Alzheimer's Disease (AD), referred for cognitive assessments in a Neurology Clinic; and b) elucidate whether TeleNP is equivalent to face-to-face evaluation (FF) for diagnostic adjudication of atypical versus typical AD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-face evaluation (FF), TeleNP evaluation | Other | In-Person (standard of care) Modality completed first, Telehealth Modality completed second |
|
| TeleNP evaluation, Face-to-face evaluation (FF) | Other | Telehealth Modality completed first, In-Person (standard of care) Modality completed second |
|
| Care Partners | No Intervention | Care Partners did not undergo the intervention; they completed outcome measures (surveys) of acceptability only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-to-face evaluation (FF) | Behavioral | The intervention is the assessment modality. The control condition is face-to-face evaluation (FF). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items | Raw scores for measures of Memory, Executive Functions, Language, and Spatial Abilities will be compared across both conditions. CVLT= California Verbal Learning Test- 2nd edition; Delayed recall measures Memory, total words recalled after 20-minutes (range: 0-16). Higher=better. RBANS = Repeatable Battery for the Assessment of Neuropsychological Status; Delayed recall (Memory) - total elements recalled (range: 0-20). Higher=better. Figure Copy (Spatial)- total copied (range: 0-20). BNT=Boston Naming Test (Language) -total correct (range: 0-15). Higher=better. Category Fluency (Language) - total correct) (range: 0- no limit). Higher=better. JoLO=Judgment of Line Orientation (Spatial) -total correct (range: 0-15). Higher=better | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
| Agreement of Neuropsychologist Diagnosis Across Testing Modalities as Measured by Neuropsychologist-Determined Diagnosis | Neuropsychologist-determined diagnosis (i.e., typical AD, atypical/complex AD, not AD) will be compared across both conditions whether TeleNP alters assessment of patient diagnosis. | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
| Agreement of Neuropsychologist Appraisal of Severity Across Testing Modalities as Measured by Neuropsychologist-Determined Severity | Neuropsychologist-determined severity (i.e., subjective cognitive concerns; MCI; mild dementia) will be compared across both conditions whether TeleNP alters assessment of patient severity. | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
| Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note that care partners (3rd arm) did not undergo the intervention and there were no additional eligibility requirements for them except that they were involved in the patient's care
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brianne Bettcher, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus (CU-AMC) | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Intervention Arms (Patients): Upon consenting for the study, randomization was conducted using a computerized process through REDCap based on block randomization with blocks of sizes 32, 24, 16, and two of 8 based on modality (FF vs TeleNP) order, test form type (standard vs alternate; used for a subset of tests), and assigned to one of two board certified neuropsychologists.
Non-Intervention Arm (Care Partner): Care partners were not assigned to an intervention, no pre-assignment details
Intervention (Patients): Eligible participants were adults ≥age 60 years and <90 years whose severity was MCI or mild dementia. Behavioral neurologists referred patients based on: a) the patient was undergoing initial diagnostic evaluation, b) the neurologist intended to place a referral for a neuropsychological evaluation, and c) Alzheimer's Disease was on the differential diagnostic workup.
Non-intervention (Care Partners): There were no eligibility requirements for the care partner
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Face-to-face Evaluation (FF), Teleneuropsychology Evaluation (TeleNP) | Study participants underwent both modalities (FF; TeleNP), conducted 4-6 weeks apart (allowing for maximum of 90 days). Order of modality, either FF followed by TeleNP or vice versa, was randomized at baseline using a computerized process through REDCap. |
| FG001 | Teleneuropsychology Evaluation (TeleNP), Face-to-face Evaluation (FF) | Study participants underwent both modalities (TeleNP; FF), conducted 4-6 weeks apart (allowing for maximum of 90 days). Order of modality, either TeleNP followed by FF or vice versa, was randomized at baseline using a computerized process through REDCap. |
| FG002 | Care Partners | Care partners of patients who were enrolled in the intervention trial were consented to fill out surveys. They did not undergo an intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The n=50 care partners did not undergo the intervention
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Face-to-face Evaluation (FF), Teleneuropsychology Evaluation (TeleNP) | Study participants underwent both modalities (FF; TeleNP), conducted 4-6 weeks apart (allowing for maximum of 90 days). Order of modality, either FF followed by TeleNP or vice versa, was randomized at baseline using a computerized process through REDCap. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Total column reflects intervention only metrics, and doesn't include care partners (who did not participate in an intervention) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items | Raw scores for measures of Memory, Executive Functions, Language, and Spatial Abilities will be compared across both conditions. CVLT= California Verbal Learning Test- 2nd edition; Delayed recall measures Memory, total words recalled after 20-minutes (range: 0-16). Higher=better. RBANS = Repeatable Battery for the Assessment of Neuropsychological Status; Delayed recall (Memory) - total elements recalled (range: 0-20). Higher=better. Figure Copy (Spatial)- total copied (range: 0-20). BNT=Boston Naming Test (Language) -total correct (range: 0-15). Higher=better. Category Fluency (Language) - total correct) (range: 0- no limit). Higher=better. JoLO=Judgment of Line Orientation (Spatial) -total correct (range: 0-15). Higher=better | Three participants who underwent the intervention signed a consent but did not complete baseline. Care Partners did not undergo the intervention and thus are not included in these outcomes. | Posted | Mean | Standard Deviation | score on a scale | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
From enrollment until the patient's evaluation feedback session (i.e., when final feedback session was conducted to the patient, within 3 months of their baseline visit). Note that care partners (arm 3) did not undergo the intervention and thus AEs were not collected or reported.
Note that care partners (arm 3) did not undergo the intervention and thus AEs were not collected or reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Face-to-face Evaluation (FF) | Face to Face evaluation (standard of care) | 0 |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brianne Bettcher, PhD, ABPP-CN | Department of Neurology, University of Colorado Anschutz Medical Campus (CU-AMC) | (303) 724-3941 | brianne.bettcher@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2022 | Aug 8, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| TeleNP evaluation | Behavioral | The intervention is the assessment modality. The intervention condition is TeleNP evaluation. |
|
The 4-item Acceptability and Feasibility of Intervention Measures Scale is used for rating all participants and care partners' perspective on the acceptability and feasibility of the Face-to-face evaluation (FF) and TeleNP evaluation as assessed using a 5-point Likert scale at Week 1 or Weeks 5-7, depending on randomization. Scores range from "Completely disagree" (1) to "Completely agree" (5).
| After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
| Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT Questionnaire Adapted to TeleNP | The UTAUT questionnaire adapted to TeleNP is used for rating all participants' perspective on the acceptability and feasibility of TeleNP evaluation as assessed using a 5-point Likert scale at Week 1 or Weeks 5-7, depending on randomization. Scores range from "Strongly disagree" (1) to "Strongly agree" (5). Performance expectancy refers to the degree to which an individual believes that using a technology will help them improve their performance. Effort expectancy is the degree of ease associated with using the technology. Behavioral intention reflects an individual's plan to use the technology. | After the exposure to the TeleNP evaluation (up to Week 7) |
| Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores (Timed Measures) | Raw scores for measures of Executive Functions will be compared across both conditions. DKEFS= Delis-Kaplan Executive Function Systems; Color-Word Inhibition (Executive Functions) -total time (range: 0-180"). Higher=worse Oral Trail Making Test B (Executive Functions) total time (range: 0-300"). Higher=worse | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
| Teleneuropsychology Evaluation (TeleNP), Face-to-face Evaluation (FF) |
Study participants underwent both modalities (TeleNP; FF), conducted 4-6 weeks apart (allowing for maximum of 90 days). Order of modality, either TeleNP followed by FF or vice versa, was randomized at baseline using a computerized process through REDCap. |
| BG002 | Care Partner | Care Partners did not undergo the intervention. They filled out acceptability surveys, which were an outcome measure |
| BG003 | Total | Total of all reporting groups |
Differences between numbers: 3 participants signed consent but did not complete baseline |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Differences between numbers: 3 participants signed consent but did not complete baseline | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Differences between numbers: 3 participants signed consent but did not complete baseline | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Differences between numbers: 3 participants signed consent but did not complete baseline | Count of Participants | Participants | No |
|
| Diagnosis (By Referring Neurologist): Atypical AD, Typical AD | "Typical AD" was defined as patients with a memory-predominant presentation of AD. "Atypical/complex AD" was defined as patients with either a) a non-memory predominant phenotype of AD or b) a complex/unclear presentation | Differences between numbers: 3 participants signed consent but did not complete baseline | Count of Participants | Participants | No |
|
| Severity Level: MCI, Mild Dementia | MCI and Dementia level of severity were based on neurologist determination, consistent with NIA-AA clinical criteria. MCI represents a change in cognitive functioning from baseline, with activities of daily living mostly preserved. Dementia represents a change in cognitive functioning from baseline that impacts activities of daily living. Dementia represents a greater/worse severity level than MCI. | Differences between numbers: 3 participants signed consent but did not complete baseline | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Teleneuropsychology (TeleNP) | Neuropsychological assessment administered via remote, home-based telehealth |
| OG001 | Face-to-Face (FF) | Neuropsychological assessment administered in-person |
|
|
|
| Primary | Agreement of Neuropsychologist Diagnosis Across Testing Modalities as Measured by Neuropsychologist-Determined Diagnosis | Neuropsychologist-determined diagnosis (i.e., typical AD, atypical/complex AD, not AD) will be compared across both conditions whether TeleNP alters assessment of patient diagnosis. | Three participants signed a consent but did not complete baseline. Neuropsychologist (n=2 neuropsychologists)-determine diagnostic agreement for all participants (n=63) will be determined between the modalities. | Posted | Mean | 95% Confidence Interval | Cohen's Kappa | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
|
|
|
|
| Primary | Agreement of Neuropsychologist Appraisal of Severity Across Testing Modalities as Measured by Neuropsychologist-Determined Severity | Neuropsychologist-determined severity (i.e., subjective cognitive concerns; MCI; mild dementia) will be compared across both conditions whether TeleNP alters assessment of patient severity. | Three participants signed a consent but did not complete baseline. Neuropsychologist (n=2 neuropsychologists)-determine diagnostic agreement for all participants (n=63) will be determined between the modalities. | Posted | Mean | 95% Confidence Interval | Cohen's Kappa | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
|
|
|
|
| Primary | Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale | The 4-item Acceptability and Feasibility of Intervention Measures Scale is used for rating all participants and care partners' perspective on the acceptability and feasibility of the Face-to-face evaluation (FF) and TeleNP evaluation as assessed using a 5-point Likert scale at Week 1 or Weeks 5-7, depending on randomization. Scores range from "Completely disagree" (1) to "Completely agree" (5). | For the patients (i.e., the primary participants), 3 participants signed a consent but did not complete baseline. N=63. For the care partners, it was not a requirement that the patient's have a care partner. Results are provided for the care partners who were available and consented (n=50). | Posted | Median | Inter-Quartile Range | Score on a Scale | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
|
|
|
| Primary | Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT Questionnaire Adapted to TeleNP | The UTAUT questionnaire adapted to TeleNP is used for rating all participants' perspective on the acceptability and feasibility of TeleNP evaluation as assessed using a 5-point Likert scale at Week 1 or Weeks 5-7, depending on randomization. Scores range from "Strongly disagree" (1) to "Strongly agree" (5). Performance expectancy refers to the degree to which an individual believes that using a technology will help them improve their performance. Effort expectancy is the degree of ease associated with using the technology. Behavioral intention reflects an individual's plan to use the technology. | For the patients (i.e., the primary participants), 3 participants signed a consent but did not complete baseline. N=63. | Posted | Median | Full Range | Score (Higher=more acceptable, range 1-5 | After the exposure to the TeleNP evaluation (up to Week 7) |
|
|
|
| Primary | Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores (Timed Measures) | Raw scores for measures of Executive Functions will be compared across both conditions. DKEFS= Delis-Kaplan Executive Function Systems; Color-Word Inhibition (Executive Functions) -total time (range: 0-180"). Higher=worse Oral Trail Making Test B (Executive Functions) total time (range: 0-300"). Higher=worse | Three participants signed a consent but did not complete baseline | Posted | Mean | Standard Deviation | seconds | After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7 |
|
|
|
|
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Teleneuropsychology Evaluation (TeleNP) | Teleneuropsychology evaluation, intervention condition | 0 | 63 | 0 | 63 | 0 | 63 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Typical AD |
|
| Mild Dementia |
|
| TeleNP. Feasibility of Intervention Measure. Range 1-5; Higher=More Acceptable |
|
| FF (Face-to-Face). Acceptability of Intervention Measure. Range 1-5; Higher=More Acceptable |
|
| FF (Face-to-Face). Intervention Appropriateness Measure. Range 1-5; Higher=More Acceptable |
|
| FF (Face-to-Face). Feasibility of Intervention Measure. Range 1-5; Higher=More Acceptable |
|
|
ICC with 95% CI for Executive Functions, DKEFS Color Word-Inhibition shown.
| Other |
Intraclass correlation coefficient (ICC) |
| Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model. Results for Executive Functions:Oral Trail Making Test B shown below. | Not applicable, ICC level of agreements interpreted. | ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-<0.50 are considered poor, 0.50≤-<0.75 moderate, 0.75≤-<0.90 good, and 0.90≤-1 excellent. ICCs were adjusted for age and sex. | Intraclass correlation | 0.88 | 2-Sided | 95 | 0.81 | 0.93 | ICC with 95% CI for Executive Functions, Oral Trail Making Test B shown. | Other | Intraclass correlation coefficient (ICC) |