Health-eBrain Study

Not Applicable

Withdrawn

• Conditions: Depression and Burden in Caregivers
• Interventions: Behavioral: Mindoula; Device: DANA

• Registration Number: NCT02903862
• Lead Sponsor: AnthroTronix, Inc.

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	DANA	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.
Waitlist Control Arm	DANA	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.
Intervention Arm	Mindoula	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline M3 Behavioral Scale score over 12 weeks	At baseline, and 4, 8, and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AnthroTronix Inc; 🇺🇸 Silver Spring, Maryland, United States