Back to resultsCaregiver Solutions for Dementia Patients
Primary Purpose
Alzheimer's Disease, Dementia, Caregivers
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Outpost
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria: Caregiver of a Duke patient with Alzheimer's disease or Alzheimer's disease-related dementias (ADRD), participating in the Duke Dementia Family Support Program The ability to speak and understand English Age > 18 years Exclusion Criteria: Those unable to speak and understand English Age ≤ 18 years
Sites / Locations
- Duke UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Digital Outpost
Arm Description
Outcomes
Primary Outcome Measures
Number of Days that Participants Use Digital Outpost
Completion of at least 75% of Digital Outpost across 4 days within a 2-week period
Number of Clinical Assessments Completed
Completion of at least 75% of Clinical Assessments
Secondary Outcome Measures
Usability as Measured by the System Usability Scale at 2 weeks
The System Usability Scale will be used for rating technology usability. The measure has 10 items. Each item is measured on a 10-point scale ranging from 0-10. The total score ranges from 0-100, where higher scores indicate greater usability.
Full Information
NCT ID
NCT05888610
First Posted
May 10, 2023
Last Updated
July 7, 2023
Sponsor
Prepped Health LLC
Collaborators
Duke University
1. Study Identification
Unique Protocol Identification Number
NCT05888610
Brief Title
Caregiver Solutions for Dementia Patients
Official Title
Identifying Specifications for Caregiver-assisted Solutions to Assess Dementia Patient Needs at Home
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prepped Health LLC
Collaborators
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to test a mobile application amongst caregiver's supporting patients diagnosed with Alzheimer's Disease and Related Dementias (ADRD). The main question it aims to answer is: Will caregivers supporting patients diagnosed with ADRD utilize a mobile application to routinely report symptoms of the patients they care for?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia, Caregivers, Remote Monitoring
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital Outpost
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Digital Outpost
Intervention Description
A mobile application that allows caregivers of patients diagnosed with Alzheimer's Disease and Related Dementias to report patient symptom remotely to their clinical team.
Primary Outcome Measure Information:
Title
Number of Days that Participants Use Digital Outpost
Description
Completion of at least 75% of Digital Outpost across 4 days within a 2-week period
Time Frame
Time Frame up to week 2
Title
Number of Clinical Assessments Completed
Description
Completion of at least 75% of Clinical Assessments
Time Frame
Time Frame up to week 2
Secondary Outcome Measure Information:
Title
Usability as Measured by the System Usability Scale at 2 weeks
Description
The System Usability Scale will be used for rating technology usability. The measure has 10 items. Each item is measured on a 10-point scale ranging from 0-10. The total score ranges from 0-100, where higher scores indicate greater usability.
Time Frame
Time Frame 2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Caregiver of a Duke patient with Alzheimer's disease or Alzheimer's disease-related dementias (ADRD), participating in the Duke Dementia Family Support Program
The ability to speak and understand English
Age > 18 years
Exclusion Criteria:
Those unable to speak and understand English
Age ≤ 18 years
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Ramos, PhD
Phone
919-416-3434
Email
Katherine.Ramos@duke.edu
12. IPD Sharing Statement
Learn more about this trial
Caregiver Solutions for Dementia Patients
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