Back to resultsVIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP) (VITAL-NP)
Primary Purpose
Suspected Typical Alzheimer's Disease (AD), Suspected Atypical Alzheimer's Disease (AD)
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Face-to-face evaluation (FF)
TeleNP evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Suspected Typical Alzheimer's Disease (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).
Sites / Locations
- University of Colorado Anschutz Medical Campus (CU-AMC)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Face-to-face evaluation (FF), TeleNP evaluation
TeleNP evaluation, Face-to-face evaluation (FF)
Arm Description
Outcomes
Primary Outcome Measures
Equivalence of Cognitive Test Results Across Testing Modalities as measured by Neuropsychological Test Mean Scores
Norm-referenced Z-scores for clinically validated cognitive measures of Memory, Executive Functions, Language, and Spatial Abilities will be compared across both conditions.
Equivalence 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.
Equivalence 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.
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).
Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT questionnaire adapted to TeleNP
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).
User experience of patient and any associated care partners for 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.
User experience of neuropsychologist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
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.
User experience of psychometrist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05379023
First Posted
May 2, 2022
Last Updated
September 25, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05379023
Brief Title
VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP)
Acronym
VITAL-NP
Official Title
Integrating Home-Based Video Teleneuropsychology Into Clinical Practice: Typical Versus Atypical Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected Typical Alzheimer's Disease (AD), Suspected Atypical Alzheimer's Disease (AD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Face-to-face evaluation (FF), TeleNP evaluation
Arm Type
Other
Arm Title
TeleNP evaluation, Face-to-face evaluation (FF)
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face evaluation (FF)
Intervention Description
The intervention is the assessment modality. The control condition is face-to-face evaluation (FF).
Intervention Type
Behavioral
Intervention Name(s)
TeleNP evaluation
Intervention Description
The intervention is the assessment modality. The intervention condition is TeleNP evaluation.
Primary Outcome Measure Information:
Title
Equivalence of Cognitive Test Results Across Testing Modalities as measured by Neuropsychological Test Mean Scores
Description
Norm-referenced Z-scores for clinically validated cognitive measures of Memory, Executive Functions, Language, and Spatial Abilities will be compared across both conditions.
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
Title
Equivalence of Neuropsychologist Diagnosis Across Testing Modalities as measured by Neuropsychologist-Determined Diagnosis
Description
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
Title
Equivalence of Neuropsychologist Appraisal of Severity Across Testing Modalities as measured by Neuropsychologist-Determined Severity
Description
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
Title
Acceptability and Feasibility of Intervention Measures as measured by 4-item Acceptability and Feasibility of Intervention Measures Scale
Description
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).
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
Title
Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT questionnaire adapted to TeleNP
Description
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).
Time Frame
After the exposure to the TeleNP evaluation (up to Week 7)
Title
User experience of patient and any associated care partners for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
Description
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.
Time Frame
1 week after the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
Title
User experience of neuropsychologist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
Description
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.
Time Frame
Up to two years
Title
User experience of psychometrist for each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation
Description
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.
Time Frame
Up to two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Krupa, BA
Phone
970-633-0216
Email
Jennifer.Krupa@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Neurology Research Partners
Phone
303-724-4644
Email
neuroresearch@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brianne Bettcher, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus (CU-AMC)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Krupa, BA
Phone
970-633-0216
Email
Jennifer.Krupa@cuanschutz.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP)
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