Clinical trial NCT02903862: Health-eBrain Study
Official title: Caregivers Virtual Health eBrain Study II
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression and Burden in Caregivers
Keywords: Caregivers
Case Management
Alzheimer's Disease
Cognition
Caregiver Burden
Depression
Lead sponsor: AnthroTronix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bright Focus Foundation
name: Mindoula Health Inc.
name: 21st Century Brain Trust
name: Geoffrey Beene Foundation
First posted: 2016-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

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

Primary outcomes:
measure: Change from baseline M3 Behavioral Scale score over 12 weeks
timeFrame: At baseline, and 4, 8, and 12 weeks.
Secondary outcomes:
measure: Change from baseline Zarit Burden Inventory score over 12 weeks
timeFrame: At baseline, and 4, 8, and 12 weeks.
measure: Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks
timeFrame: At baseline, and 4, 8, and 12 weeks.
Other outcomes:
measure: Usability Questionnaire
timeFrame: At baseline, and 4, 8, and 12 weeks.
measure: Paired Associates Learning
timeFrame: At baseline and 12 weeks
measure: PERMA Profiler
timeFrame: At baseline and 12 weeks
Locations:
city: Silver Spring
country: United States
facility: AnthroTronix Inc
state: Maryland
Study officials:
affiliation: AnthroTronix, Inc.
name: Corinna E Lathan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.