Clinical trial NCT05379023: VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP)
Official title: Integrating Home-Based Video Teleneuropsychology Into Clinical Practice: Typical Versus Atypical Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suspected Typical Alzheimer's Disease (AD)
Suspected Atypical Alzheimer's Disease (AD)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-05-18
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Equivalence of Cognitive Test Results Across Testing Modalities as measured by Neuropsychological Test Mean Scores
timeFrame: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7
measure: Equivalence of Neuropsychologist Diagnosis Across Testing Modalities as measured by Neuropsychologist-Determined Diagnosis
timeFrame: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7
measure: Equivalence of Neuropsychologist Appraisal of Severity Across Testing Modalities as measured by Neuropsychologist-Determined Severity
timeFrame: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7
measure: Acceptability and Feasibility of Intervention Measures as measured by 4-item Acceptability and Feasibility of Intervention Measures Scale
timeFrame: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7
measure: Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT questionnaire adapted to TeleNP
timeFrame: After the exposure to the TeleNP evaluation (up to Week 7)
measure: User experience of patient and any associated care partners for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
timeFrame: 1 week after the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
measure: User experience of neuropsychologist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
timeFrame: Up to two years
measure: User experience of psychometrist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
timeFrame: Up to two years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus (CU-AMC)
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Brianne Bettcher, PhD
role: PRINCIPAL_INVESTIGATOR
References: