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

NCT ID: NCT05379023

Last Updated: 2025-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2024-05-16

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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

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

Group Type OTHER

Face-to-face evaluation (FF)

Intervention Type BEHAVIORAL

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

TeleNP evaluation

Intervention Type BEHAVIORAL

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

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

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

Group Type OTHER

Face-to-face evaluation (FF)

Intervention Type BEHAVIORAL

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

TeleNP evaluation

Intervention Type BEHAVIORAL

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

Care Partners

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Face-to-face evaluation (FF)

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

Intervention Type BEHAVIORAL

TeleNP evaluation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brianne Bettcher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus (CU-AMC)

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R21AG072153

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-5037

Identifier Type: -

Identifier Source: org_study_id