Trial Outcomes & Findings for VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP) (NCT NCT05379023)

Last Updated: 2025-12-31

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

116 participants

Primary outcome timeframe

After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Results posted on

2025-12-31

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	35	31	50
Overall Study COMPLETED	32	31	50
Overall Study NOT COMPLETED	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	2	0	0

Baseline Characteristics

Differences between numbers: 3 participants signed consent but did not complete baseline

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Population: 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.

Outcome measures

Outcome measures
Measure	Care Partner (Acceptability Measure) n=63 Participants Care Partner (care partner of primary participant/patient) report of acceptability measures	Patient (UTAUT Measure) n=63 Participants Patient (primary participant) report on UTAUT measure
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items RBANS Figure Copy (Spatial), Total Score, Higher=better score.	17.21 score on a scale Standard Deviation 2.60	17.08 score on a scale Standard Deviation 2.50
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items CVLT Delayed Recall (Memory). Total Score, Higher=better score.	4.40 score on a scale Standard Deviation 4.20	4.31 score on a scale Standard Deviation 4.30
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items RBANS Figure Delayed Recall (Memory). Total Score, Higher=better score.	8.60 score on a scale Standard Deviation 4.90	8.21 score on a scale Standard Deviation 5.20
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items BNT-15 item Total (Language), Total Score, Higher=better score.	12.52 score on a scale Standard Deviation 3.20	12.40 score on a scale Standard Deviation 3.20
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items Category Fluency Total (Language), Total Score, Higher=better score.	12.83 score on a scale Standard Deviation 5.80	13.19 score on a scale Standard Deviation 5.50
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items JoLO 15-item Total (Spatial), Total Score, Higher=better score.	11.10 score on a scale Standard Deviation 3.00	10.60 score on a scale Standard Deviation 3.40

PRIMARY outcome

Timeframe: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Care Partner (Acceptability Measure) Care Partner (care partner of primary participant/patient) report of acceptability measures	Patient (UTAUT Measure) n=63 Participants Patient (primary participant) report on UTAUT measure
Agreement of Neuropsychologist Diagnosis Across Testing Modalities as Measured by Neuropsychologist-Determined Diagnosis	—	0.74 Cohen's Kappa Interval 0.6 to 0.88

PRIMARY outcome

Timeframe: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Neuropsychologist-determined severity (i.e., subjective cognitive concerns; MCI; mild dementia) will be compared across both conditions whether TeleNP alters assessment of patient severity.

Outcome measures

Outcome measures
Measure	Care Partner (Acceptability Measure) Care Partner (care partner of primary participant/patient) report of acceptability measures	Patient (UTAUT Measure) n=63 Participants Patient (primary participant) report on UTAUT measure
Agreement of Neuropsychologist Appraisal of Severity Across Testing Modalities as Measured by Neuropsychologist-Determined Severity	—	0.89 Cohen's Kappa Interval 0.79 to 0.99

PRIMARY outcome

Timeframe: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Population: 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).

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).

Outcome measures

Outcome measures
Measure	Care Partner (Acceptability Measure) n=50 Participants Care Partner (care partner of primary participant/patient) report of acceptability measures	Patient (UTAUT Measure) n=63 Participants Patient (primary participant) report on UTAUT measure
Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale TeleNP. Acceptability of Intervention Measure. Range 1-5; Higher=More Acceptable	3.95 Score on a Scale Interval 3.3 to 4.8	4.0 Score on a Scale Interval 3.5 to 4.5
Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale TeleNP. Intervention Appropriateness Measure. Range 1-5; Higher=More Acceptable	4.0 Score on a Scale Interval 3.5 to 4.5	4.0 Score on a Scale Interval 3.5 to 4.3
Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale TeleNP. Feasibility of Intervention Measure. Range 1-5; Higher=More Acceptable	4.0 Score on a Scale Interval 3.8 to 4.8	4.0 Score on a Scale Interval 3.8 to 4.5
Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale FF (Face-to-Face). Acceptability of Intervention Measure. Range 1-5; Higher=More Acceptable	3.9 Score on a Scale Interval 3.5 to 4.3	4.0 Score on a Scale Interval 3.5 to 5.0
Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale FF (Face-to-Face). Intervention Appropriateness Measure. Range 1-5; Higher=More Acceptable	4.0 Score on a Scale Interval 4.0 to 4.8	4.0 Score on a Scale Interval 4.0 to 4.8
Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale FF (Face-to-Face). Feasibility of Intervention Measure. Range 1-5; Higher=More Acceptable	4.0 Score on a Scale Interval 3.8 to 4.8	4.0 Score on a Scale Interval 3.8 to 4.8

PRIMARY outcome

Timeframe: After the exposure to the TeleNP evaluation (up to Week 7)

Population: For the patients (i.e., the primary participants), 3 participants signed a consent but did not complete baseline. N=63.

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.

Outcome measures

Outcome measures
Measure	Care Partner (Acceptability Measure) Care Partner (care partner of primary participant/patient) report of acceptability measures	Patient (UTAUT Measure) n=63 Participants Patient (primary participant) report on UTAUT measure
Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT Questionnaire Adapted to TeleNP Performance Expectancy Domain	—	4.0 Score (Higher=more acceptable, range 1-5 Interval 3.0 to 5.0
Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT Questionnaire Adapted to TeleNP Effort Expectancy Domain	—	4.0 Score (Higher=more acceptable, range 1-5 Interval 3.0 to 4.0
Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT Questionnaire Adapted to TeleNP Behavioral Intention Domain	—	4.0 Score (Higher=more acceptable, range 1-5 Interval 3.0 to 4.0

PRIMARY outcome

Timeframe: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Population: Three participants signed a consent but did not complete baseline

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

Outcome measures

Outcome measures
Measure	Care Partner (Acceptability Measure) n=63 Participants Care Partner (care partner of primary participant/patient) report of acceptability measures	Patient (UTAUT Measure) n=63 Participants Patient (primary participant) report on UTAUT measure
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores (Timed Measures) Oral Trail Making Test, Total Time	79.59 seconds Standard Deviation 83.30	88.54 seconds Standard Deviation 87.10
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores (Timed Measures) DKEFS Color-Word Inhibition Total Time	96.29 seconds Standard Deviation 38.10	104.84 seconds Standard Deviation 44.10

Adverse Events

Face-to-face Evaluation (FF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Teleneuropsychology Evaluation (TeleNP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brianne Bettcher, PhD, ABPP-CN

Department of Neurology, University of Colorado Anschutz Medical Campus (CU-AMC)

Phone: (303) 724-3941

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Face-to-face Evaluation (FF), Teleneuropsychology Evaluation (TeleNP) n=32 Participants 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.	Teleneuropsychology Evaluation (TeleNP), Face-to-face Evaluation (FF) n=31 Participants 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.	Care Partner n=50 Participants Care Partners did not undergo the intervention. They filled out acceptability surveys, which were an outcome measure	Total n=113 Participants Total of all reporting groups
Age, Continuous Patients	73.03 Years STANDARD_DEVIATION 6.49 • n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	73.74 Years STANDARD_DEVIATION 6.16 • n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	—	73.38 Years STANDARD_DEVIATION 6.29 • n=63 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Age, Continuous Care Partners	—	—	63.8 Years STANDARD_DEVIATION 12.6 • n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	63.8 Years STANDARD_DEVIATION 12.6 • n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Sex: Female, Male Female	15 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	20 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	33 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	68 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Sex: Female, Male Male	17 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	11 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	17 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	45 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	2 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	4 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	31 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	48 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	109 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Race (NIH/OMB) Asian	0 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	1 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	1 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Race (NIH/OMB) Black or African American	1 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	1 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	2 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	4 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Race (NIH/OMB) White	30 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	29 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	47 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	106 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Race (NIH/OMB) More than one race	1 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	1 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	2 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=50 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants n=113 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Diagnosis (By Referring Neurologist): Atypical AD, Typical AD Atypical AD	12 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	10 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants Differences between numbers: 3 participants signed consent but did not complete baseline	22 Participants n=63 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Diagnosis (By Referring Neurologist): Atypical AD, Typical AD Typical AD	20 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	21 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants Differences between numbers: 3 participants signed consent but did not complete baseline	41 Participants n=63 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Severity Level: MCI, Mild Dementia MCI	24 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	22 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants Differences between numbers: 3 participants signed consent but did not complete baseline	46 Participants n=63 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline
Severity Level: MCI, Mild Dementia Mild Dementia	8 Participants n=32 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	9 Participants n=31 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline	0 Participants Differences between numbers: 3 participants signed consent but did not complete baseline	17 Participants n=63 Participants • Differences between numbers: 3 participants signed consent but did not complete baseline