VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP) (VITAL-NP)

Integrating Home-Based Video Teleneuropsychology Into Clinical Practice: Typical Versus Atypical Alzheimer's Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Suspected Typical Alzheimer's Disease (AD); Suspected Atypical Alzheimer's Disease (AD)
• Intervention / Treatment: Behavioral: Face-to-face evaluation (FF); Behavioral: TeleNP evaluation

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Krupa, BA; Phone Number: 970-633-0216; Email: Jennifer.Krupa@cuanschutz.edu
• Study Contact Backup: Name: Neurology Research Partners; Phone Number: 303-724-4644; Email: neuroresearch@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus (CU-AMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals age 60 to 90 years who are undergoing evaluation for possible AD and whose severity ranges from MCI to mild dementia.
• Individuals must carry a diagnosis of either suspected typical AD or atypical AD, based on the referring neurologist's diagnosis.

Exclusion Criteria:

• Individuals with moderate to severe levels of dementia and individuals with active delirium (per neurologist's determination).
• Individuals who are legally blind or deaf, due to the auditory and visual components of the study.
• Individuals with a brain tumor and individuals who have a confirmed nonAD neurological diagnosis (e.g, Multiple Sclerosis; FTD).
• Individuals who are being evaluated outside of the UCH Memory Disorders Clinic.
• Individuals who report active (i.e., within the last 6 months) substance use of illicit drugs such as cocaine or methamphetamines, or who carry a diagnosis of a major psychiatric disorder (e.g., schizophrenia; bipolar disorder).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Face-to-face evaluation (FF), TeleNP evaluation	Behavioral: Face-to-face evaluation (FF); The intervention is the assessment modality. The control condition is face-to-face evaluation (FF).; Behavioral: TeleNP evaluation; The intervention is the assessment modality. The intervention condition is TeleNP evaluation.
Other: TeleNP evaluation, Face-to-face evaluation (FF)	Behavioral: Face-to-face evaluation (FF); The intervention is the assessment modality. The control condition is face-to-face evaluation (FF).; Behavioral: TeleNP evaluation; The intervention is the assessment modality. The intervention condition is TeleNP evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Equivalence of Cognitive Test Results Across Testing Modalities as measured by Neuropsychological Test Mean Scores	Norm-referenced Z-scores for clinically validated cognitive measures of Memory, Executive Functions, Language, and Spatial Abilities will be compared across both conditions.	After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7
Equivalence 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
Equivalence 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	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 19-item UTAUT questionnaire adapted to TeleNP is used for rating all participants and care partners' 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).	After the exposure to the TeleNP evaluation (up to Week 7)
User experience of patient and any associated care partners for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation	A subset of diverse patients (n=20) and any associated care partners will be invited to participate in semi-structured interviews with the research coordinator within one week of completing both FF and TeleNP conditions. These interviews will focus on the participant's user experience, guided by UTAUT domains and specific attention to home setting and potential care partner involvement.	1 week after the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
User experience of neuropsychologist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation	The neuropsychologists will also participate in brief, separate interviews to garner information regarding feasibility, acceptability, and strengths/weaknesses of TeleNP after the completion of 20, 40, 60, and 80 TeleNP evaluations.	Up to two years
User experience of psychometrist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation	The psychometrist will also participate in brief, separate interviews to garner information regarding feasibility, acceptability, and strengths/weaknesses of TeleNP; these interviews will be conducted by Dr. Hillary Lum after the completion of 20, 40, 60, and 80 TeleNP evaluations.	Up to two years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Brianne Bettcher, PhD, University of Colorado - Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 21-5037; R21AG072153 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No