Caregiver Solutions for Dementia Patients

November 26, 2023 updated by: Prepped Health LLC

Identifying Specifications for Caregiver-assisted Solutions to Assess Dementia Patient Needs at Home

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Outpost
Behavioral: Digital Outpost
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days that Participants Use Digital Outpost
Time Frame: Time Frame up to week 2
Completion of at least 75% of Digital Outpost across 4 days within a 2-week period
Time Frame up to week 2
Number of Clinical Assessments Completed
Time Frame: Time Frame up to week 2
Completion of at least 75% of Clinical Assessments
Time Frame up to week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability as Measured by the System Usability Scale at 2 weeks
Time Frame: Time Frame 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.
Time Frame 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prepped Health LLC

Collaborators

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Actual)

July 12, 2023

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00109123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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