Caregiver Solutions for Dementia Patients

Sponsor

Prepped Health LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05888610

Collaborator

Duke University (Other)

Enrollment

Arm

Anticipated Duration (Days)

Study Details

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?

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Dementia Caregivers Remote Monitoring	Behavioral: Digital Outpost	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Usability as Measured by the System Usability Scale at 2 weeks [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Prepped Health LLC
Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prepped Health LLC

ClinicalTrials.gov Identifier:

NCT05888610

Other Study ID Numbers:

00109123

First Posted:

Jun 5, 2023

Last Update Posted:

Jun 5, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Dementia

Study Results

No Results Posted as of Jun 5, 2023