NCT04626804

Brief Summary

Test the usability, perceptions and acceptability of a computer monitor for participant diagnosed with ADRD and their caregiver who will program the applications specifically for each individual to help them remember activities of daily living. Goal is to keep participants in their homes longer and delay the need for institutional care

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

November 3, 2020

Last Update Submit

February 27, 2023

Conditions

Keywords

Alzheimer's diseaseDementiaCaregivingCaregiverAnxietyTelehealth

Outcome Measures

Primary Outcomes (1)

  • Usability

    Satisfaction and use of the monitor and apps using the Usability Scale, a validated 10-item scale sithe items suchs as "learning to use the calendar function was quick for me", using a 5 point response scale (0= strongly disagree to 5= strongly agree) Usability Scale, a validated 10-item scale (e.g. "Learning to use Calendar function was quick for me" using a 5-point response scale (0=strongly disagree to 5= strongly agree)

    through study completion, an average of 4 months

Secondary Outcomes (4)

  • Acceptability

    through study completion, an average of 4 months

  • Intention of Use

    through study completion, an average of 4 months

  • Performance expectancy

    through study completion, an average of 4 months

  • Computer literacy

    through study completion, an average of 4 months

Other Outcomes (1)

  • Dementia Severity Scale

    through study completion, an average of 4 month

Study Arms (1)

1 Test the usability, perceptions, and acceptability of R/S

EXPERIMENTAL

Dyads will use the R/S unit for 90 days, unless they request it to be removed prior to the end of the study. . The primary outcome is a caregiver-assessed measure usability.

Other: Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community

Interventions

testing the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias

Also known as: System Usability Scale, Participant Willingness to Use, The Behavioral Intention Scale, Performance Expectancy, Computer Literacy
1 Test the usability, perceptions, and acceptability of R/S

Eligibility Criteria

Age21 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • achieve a Montreal Cognitive Assessment (MoCA) score of 6-17 (mild to moderate dementia)
  • diagnosis of early Alzheimer's disease or related dementia or caregiver reports ADRD diagnosis (if community based recruitment)
  • provide identification of a caregiver (living with or otherwise involved in the ongoing care of the person with ADRD)
  • able to communicate in English
  • able to provide informed consent

You may not qualify if:

  • lives in a nursing home or long term care facility or assisted living facility
  • do not pass the MoCA with a score between 6-17
  • unable to identify a caregiver
  • is limited by severe arthritis or other condition in the use of his/her hands
  • years or older
  • able to provide informed consent
  • able to communicate in English
  • under 21 years of age
  • does not have access to a computer/device
  • diagnosis of ADRD
  • diagnosis of serious mental illness (i.e. schizophrenia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46022, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionCaregiver BurdenGeneralized Anxiety DisorderAlzheimer DiseaseDementia

Interventions

Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorStress, PsychologicalBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Amyloidogenic ProteinsAmyloidProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsProtein PrecursorsProtease NexinsProteinase Inhibitory Proteins, Secretory

Study Officials

  • Nicole R Fowler, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: single dyadic group focused on determining acceptance and feasibility of the in home computer monitor individually programmed for each dyadic needs
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 13, 2020

Study Start

October 27, 2020

Primary Completion

December 16, 2021

Study Completion

December 31, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

In future manuscripts, the authors will list contact information and state that the IPD is available upon request

Time Frame
at the completion of the study, within 12 months
Access Criteria
at the completion of the study, within 12 months

Locations