Health-eBrain Study

NCT ID: NCT02903862

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-07-31

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.

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.

Conditions

Depression and Burden in Caregivers

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindoula

Intervention Type: 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.

DANA

Intervention Type: 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.

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.

Group Type: OTHER

DANA

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bright Focus Foundation

UNKNOWN

Sponsor Role: collaborator

Mindoula Health Inc.

UNKNOWN

Sponsor Role: collaborator

21st Century Brain Trust

OTHER

Sponsor Role: collaborator

Geoffrey Beene Foundation

UNKNOWN

Sponsor Role: collaborator

AnthroTronix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinna E Lathan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

AnthroTronix, Inc.

Locations

AnthroTronix Inc

Silver Spring, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27099613 (View on PubMed)

Other Identifiers

091614A

Identifier Type: -

Identifier Source: org_study_id