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NCT05827094 · ClinicalTrials.gov registry record · NA

Pilot Mobile for Dementia and Frailty

A NA study of Dementia and Frailty, sponsored by University of Washington.

Completed
Registry status
NA
Development phase
19
Enrollment target
1
Study location

NCT05827094 is a NA study of Dementia and Frailty that has completed, run by University of Washington. The registered enrollment target is 19 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05827094, a NA study of Dementia and Frailty, has completed, sponsored by University of Washington.

COMPLETED
Registry status
NA
Development phase
19 participants
Enrollment target
1
Study location

Study Summary

In this project, we propose to build on our Stage I formative work (according to the NIH Stage Model for Behavioral Intervention Development), where we developed fully functional prototypes of a mobile intervention aimed at improving adherence to Mediterranean Diet (MedD) for older adults with frailty and early dementia to complete the Stage II exploratory work, where the intervention will undergo further feasibility, acceptability, and preliminary efficacy tests. The intervention includes a patient-facing app that allows users to track their diet and receive personalized feedback concerning opportunities for improvement and recipes for breakfast, lunch, dinner, and snacks, informational materials about MedD, and a chat feature. On the other end, a web-based provider interface allows clinicians to review patient progress, suggest meal plans, and send and receive messages. The pilot randomized controlled trial, conducted over three months, will compare usual care to usual care plus mobile intervention to gather preliminary efficacy data concerning a change in adherence to MedD score (primary outcome). Mechanistic and secondary outcomes will include MedD knowledge, constructs from Social Cognitive Theory (self-efficacy, outcome expectation, self-regulation, and social support), platform use, anthropometric, and functional measures. Feasibility will be evaluated in terms of recruitment and retention outcomes. Acceptability will be determined through post-intervention semi-structured interviews and structured survey measures.

Conditions Studied

Interventions

  • OTHER Usual Care
  • OTHER Mobile app

Study Locations (1)

Washington

  • Univeristy of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2023-06-06
Est. Completion 2024-03-15
Phase NA

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT05827094

The ClinicalTrials.gov registry entry for NCT05827094 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.

NCT05827094 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT05827094 about?

NCT05827094 is a clinical study titled "Pilot Mobile for Dementia and Frailty". In this project, we propose to build on our Stage I formative work (according to the NIH Stage Model for Behavioral Intervention Development), where we developed fully functional prototypes of a mobile intervention aimed at improving adherence to Mediterranean Diet (MedD) for older adults with frail...

What is the current status of trial NCT05827094?

This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2023-06-06. Estimated completion is 2024-03-15.

What conditions does trial NCT05827094 study?

This clinical trial studies the following conditions: Dementia, Frailty.

What interventions are being tested in trial NCT05827094?

The interventions under investigation include: Usual Care (OTHER), Mobile app (OTHER).

Who is sponsoring clinical trial NCT05827094?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05827094 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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