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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Suspected Typical Alzheimer's Disease (AD); Suspected Atypical Alzheimer's Disease (AD)

Treatments: Behavioral: Face-to-face evaluation (FF); Behavioral: TeleNP evaluation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05379023

R21AG072153 (U.S. NIH Grant/Contract)

21-5037

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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116 participants in 3 patient groups

Face-to-face evaluation (FF), TeleNP evaluation

Other group

Description:

In-Person (standard of care) Modality completed first, Telehealth Modality completed second

Treatment:

Behavioral: TeleNP evaluation

Behavioral: Face-to-face evaluation (FF)

TeleNP evaluation, Face-to-face evaluation (FF)

Other group

Description:

Telehealth Modality completed first, In-Person (standard of care) Modality completed second

Treatment:

Behavioral: TeleNP evaluation

Behavioral: Face-to-face evaluation (FF)

Care Partners

No Intervention group

Description:

Care Partners did not undergo the intervention; they completed outcome measures (surveys) of acceptability only.