Health-eBrain Study
| Status: | Withdrawn |
|---|---|
| Conditions: | Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 45 - 75 |
| Updated: | 7/5/2018 |
| Start Date: | July 2016 |
| End Date: | July 2017 |
Caregivers Virtual Health eBrain Study II
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.
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.
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.
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.
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
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