Health-eBrain Study (HeB)

Caregivers Virtual Health eBrain Study II

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression and Burden in Caregivers
• Intervention / Treatment: Behavioral: Mindoula; Device: DANA

Detailed Description

This study will track the mental status and cognition of caregivers with and without the Mindoula and DANA intervention and use subject feedback to aid in designing future interventions for caregivers.

This is a remotely administered, virtual study targeting dementia caregivers who are mild to moderately depressed. Screening calls for online administration of four surveys to determine inclusion in the study arms. These surveys will be taken on the Health-eBrain website, both at baseline/screening and throughout participation. All other participation will be completed on the participant's mobile phone, and all psychological and cognitive tests will be self-administered.

This study has a between-group design. Participants will be screened for eligibility and then randomized into each arm. The intervention arm will receive the Mindoula plus DANA intervention. The wait list control arm will take the psychological surveys at regular intervals then, after 12 weeks, be enrolled in the DANA-only observation group. The DANA-only group will take DANA and a usability questionnaire.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • AnthroTronix Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Participants in the Intervention and Waitlist Control Arms must meet the following additional inclusion criteria:

• 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

Exclusion Criteria:

• 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
• Failure to meet all inclusion criteria per arm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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; 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.
Other: Waitlist Control Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline M3 Behavioral Scale score over 12 weeks	At baseline, and 4, 8, and 12 weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability Questionnaire	Survey on using DANA that will help the researchers better understand the development of technologies for this population	At baseline, and 4, 8, and 12 weeks.
Paired Associates Learning	The PAL assesses visual memory and new learning.	At baseline and 12 weeks
PERMA Profiler	This survey assesses five core element of psychological well-being and happiness - Positive emotions, Engagement, Relationships, Meaning, and Accomplishments - as well as subjective wellbeing and sense of loneliness.	At baseline and 12 weeks

Collaborators and Investigators

• Sponsor: AnthroTronix, Inc.
• Collaborators: Bright Focus Foundation; Mindoula Health Inc.; 21st Century Brain Trust; Geoffrey Beene Foundation
• Investigators: Principal Investigator: Corinna E Lathan, Ph.D, AnthroTronix, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Alzheimer's Disease; Caregiver Burden; Cognition; Caregivers; Case Management
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 091614A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO