Health-eBrain Study

Depression and Burden in Caregivers Clinical Trial

— HeB  

Official title:

Caregivers Virtual Health eBrain Study II

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02903862
• Other study ID #: 091614A
• Status: Withdrawn
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: June 2018
• Source: AnthroTronix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression and Burden in Caregivers

Intervention

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.

Locations

Country	Name	City	State
United States	AnthroTronix Inc	Silver Spring	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
AnthroTronix, Inc.	21st Century Brain Trust, Bright Focus Foundation, Geoffrey Beene Foundation, Mindoula Health Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Paired Associates Learning	The PAL assesses visual memory and new learning.	At baseline and 12 weeks
Other	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
Primary	Change from baseline M3 Behavioral Scale score over 12 weeks		At baseline, and 4, 8, and 12 weeks.
Secondary	Change from baseline Zarit Burden Inventory score over 12 weeks		At baseline, and 4, 8, and 12 weeks.
Secondary	Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks		At baseline, and 4, 8, and 12 weeks.

External Links

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