HeB: Health-eBrain Study

Sponsor

AnthroTronix, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02903862

Collaborator

Bright Focus Foundation (Other), Mindoula Health Inc. (Other), 21st Century Brain Trust (Other), Geoffrey Beene Foundation (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression and Burden in Caregivers	Behavioral: Mindoula Device: DANA	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Caregivers Virtual Health eBrain Study II

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Change from baseline M3 Behavioral Scale score over 12 weeks [At baseline, and 4, 8, and 12 weeks.]

Secondary Outcome Measures

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

Usability Questionnaire [At baseline, and 4, 8, and 12 weeks.]
Survey on using DANA that will help the researchers better understand the development of technologies for this population
Paired Associates Learning [At baseline and 12 weeks]
The PAL assesses visual memory and new learning.
PERMA Profiler [At baseline and 12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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