NCT05888610

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

May 10, 2023

Last Update Submit

November 26, 2023

Conditions

Alzheimer's DiseaseDementiaCaregiversRemote Monitoring

Outcome Measures

Primary Outcomes (2)

  • Number of Days that Participants Use Digital Outpost

    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

    Completion of at least 75% of Clinical Assessments

    Time Frame up to week 2

Secondary Outcomes (1)

  • Usability as Measured by the System Usability Scale at 2 weeks

    Time Frame 2 weeks

Study Arms (1)

Digital Outpost

EXPERIMENTAL
Behavioral: Digital Outpost

Interventions

Digital OutpostBEHAVIORAL

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.

Digital Outpost

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those unable to speak and understand English
  • Age ≤ 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 5, 2023

Study Start

June 12, 2023

Primary Completion

July 12, 2023

Study Completion

July 12, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

US(1)