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

• ClinicalTrials.gov Identifier: NCT05379023
• Recruitment Status: Recruiting
• First Posted: May 18, 2022
• Last Update Posted: September 6, 2022
• Sponsor: University of Colorado, Denver
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Suspected Typical Alzheimer's Disease (AD); Suspected Atypical Alzheimer's Disease (AD)	Behavioral: Face-to-face evaluation (FF); Behavioral: TeleNP evaluation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Integrating Home-Based Video Teleneuropsychology Into Clinical Practice: Typical Versus Atypical Alzheimer's Disease
• Actual Study Start Date: June 27, 2022
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: March 2024

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Equivalence of Cognitive Test Results Across Testing Modalities as measured by Neuropsychological Test Mean Scores [ 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 ]
   Norm-referenced Z-scores for clinically validated cognitive measures of Memory, Executive Functions, Language, and Spatial Abilities will be compared across both conditions.
2. Equivalence of Neuropsychologist Diagnosis Across Testing Modalities as measured by Neuropsychologist-Determined 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 ]
   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.
3. Equivalence of Neuropsychologist Appraisal of Severity Across Testing Modalities as measured by Neuropsychologist-Determined 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 ]
   Neuropsychologist-determined severity (i.e., subjective cognitive concerns; MCI; mild dementia) will be compared across both conditions whether TeleNP alters assessment of patient severity.
4. Acceptability and Feasibility of Intervention Measures as measured by 4-item Acceptability and Feasibility of Intervention Measures Scale [ 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 ]
   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).
5. Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT questionnaire adapted to TeleNP [ Time Frame: After the exposure to the TeleNP evaluation (up to Week 7) ]
   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).
6. User experience of patient and any associated care partners for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation [ Time Frame: 1 week after the exposure to 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.
7. User experience of neuropsychologist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation [ Time Frame: Up to two years ]
   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.
8. User experience of psychometrist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation [ Time Frame: Up to two years ]
   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.

Eligibility Criteria

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

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).

Contacts and Locations

Contacts

Contact: Jennifer Krupa, BA; 970-633-0216; Jennifer.Krupa@cuanschutz.edu

Contact: Neurology Research Partners; 303-724-4644; neuroresearch@cuanschutz.edu

Locations

United States, Colorado

University of Colorado Anschutz Medical Campus (CU-AMC); Recruiting

Aurora, Colorado, United States, 80045

Contact: Jennifer Krupa, BA 970-633-0216 Jennifer.Krupa@cuanschutz.edu

Sponsors and Collaborators

University of Colorado, Denver

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Brianne Bettcher, PhD; University of Colorado - Anschutz Medical Campus

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT05379023
• Other Study ID Numbers: 21-5037; R21AG072153 ( U.S. NIH Grant/Contract )
• First Posted: May 18, 2022
• Last Update Posted: September 6, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders