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

University of Colorado, Denver116 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

116

Conditions

Suspected Typical Alzheimer's Disease (AD)Suspected Atypical Alzheimer's Disease (AD)

Interventions

Face-to-face evaluation (FF)BEHAVIORAL

The intervention is the assessment modality. The control condition is face-to-face evaluation (FF).

TeleNP evaluationBEHAVIORAL

The intervention is the assessment modality. The intervention condition is TeleNP evaluation.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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). 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

Locations (1)

University of Colorado Anschutz Medical Campus (CU-AMC)

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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