Health-eBrain Study

NCT02903862 | Withdrawn

• 1 other identifier: 091614A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Caregivers; Case Management; Alzheimer's Disease; Cognition; Caregiver Burden; Depression

Outcome Measures

Primary Outcomes (1)

• Change from baseline M3 Behavioral Scale score over 12 weeks

  At baseline, and 4, 8, and 12 weeks.

Secondary Outcomes (2)

• Change from baseline Zarit Burden Inventory score over 12 weeks

  At baseline, and 4, 8, and 12 weeks.

• Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks

  At baseline, and 4, 8, and 12 weeks.

Other Outcomes (3)

• Usability Questionnaire

  At baseline, and 4, 8, and 12 weeks.

• Paired Associates Learning

  At baseline and 12 weeks

• PERMA Profiler

  At baseline and 12 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants will receive the intervention, Mindoula plus DANA, which involves working with a case manager via an app for 12 weeks. The case manager will help the participant cope with the stresses of caregiving as well as remind them to use the DANA cognitive assessment app. This arm will also take the study's psychological surveys.

Behavioral: Mindoula; Device: DANA

Waitlist Control Arm

OTHER

These participants will take psychological surveys and a usability questionnaire for the first 12 weeks of participation, then, for the 12 weeks following, take the psychological surveys along with DANA and a usability questionnaire.

Device: DANA

Interventions

Mindoula BEHAVIORAL

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.

Intervention Arm

DANA DEVICE

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.

Intervention Arm; Waitlist Control Arm

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and males who regularly provide care for a person with Alzheimer's Disease
• Between the ages of 45-75
• Self-reported ability to speak and read English
• Providing care for at least a year
• Zarit Burden Inventory (ZBI) Score of 9+
• Overall M3 score of 33+
• M3 Depression score of 7+
• Female Only
• Minimum hours of caregiving a week must be equal to or greater than 20 hours

You may not qualify if:

• Anyone with a known cognitive diagnosis
• Anyone with color blindness
• Overall score of high risk on the M3 and/or high risk on the PTSD or Bipolar subsection of the M3

Sponsors & Collaborators

• AnthroTronix, Inc.: lead
• Bright Focus Foundation: collaborator
• Mindoula Health Inc.: collaborator
• 21st Century Brain Trust: collaborator
• Geoffrey Beene Foundation: collaborator

Study Sites (1)

AnthroTronix Inc

Silver Spring, Maryland, 20910, United States

Location

Related Publications (1)

• Lathan C, Wallace AS, Shewbridge R, Ng N, Morrison G, Resnick HE. Cognitive Health Assessment and Establishment of a Virtual Cohort of Dementia Caregivers. Dement Geriatr Cogn Dis Extra. 2016 Mar 22;6(1):98-107. doi: 10.1159/000444390. eCollection 2016 Jan-Apr.

  PMID: 27099613 BACKGROUND

Related Links

• Website where study is being conducted. Participants register and take their psychological surveys here.

MeSH Terms

Conditions

Depression; Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological

Study Officials

• Corinna E Lathan, Ph.D

  AnthroTronix, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: September 16, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)