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Health-eBrain Study

NCT02903862 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-07-03

No results posted yet for this study

Summary

The purposes of this study are to (1) track dementia caregiver health indicators over 12 weeks, both with and without the Mindoula plus DANA intervention (case manager and mobile messaging and assessment applications) to determine if the intervention improves caregiver health and (2) obtain feedback from caregivers to inform on the design of future interventions.

Conditions

  • Depression and Burden in Caregivers

Interventions

BEHAVIORAL

Mindoula

The Mindoula intervention is a combination of case management and a messenger application. Case managers monitor how the participant is doing and any needs and provide 24/7 support \& assistance, including care coordination, treatment adherence, and matching the participant with providers and community resources. Each participant will be given an intake questionnaire to establish goals and behavioral health history. Participants will use the app and work with the case manager for 12 weeks.

DEVICE

DANA

DANA is an FDA-cleared neurocognitive assessment software administered on a smartphone or tablet to measure changes in cognitive efficiency. DANA also includes Ecological Momentary Assessments to track mood, sleep, stress, and memory. Intervention participants will take DANA weekly. The Waitlist Control arm will take DANA weekly 12 weeks after enrollment.

Sponsors & Collaborators

  • Bright Focus Foundation

    collaborator UNKNOWN

  • Mindoula Health Inc.

    collaborator UNKNOWN

  • 21st Century Brain Trust

    collaborator OTHER

  • Geoffrey Beene Foundation

    collaborator UNKNOWN

  • AnthroTronix, Inc.

    lead INDUSTRY

Principal Investigators

  • Corinna E Lathan, Ph.D · AnthroTronix, Inc.

Study Design

Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903862 on ClinicalTrials.gov