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| Name | Class |
|---|---|
| Bright Focus Foundation | UNKNOWN |
| Mindoula Health Inc. | UNKNOWN |
| 21st Century Brain Trust | OTHER |
| Geoffrey Beene Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindoula | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline M3 Behavioral Scale score over 12 weeks | At baseline, and 4, 8, and 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Paired Associates Learning |
Inclusion Criteria:
Participants in the Intervention and Waitlist Control Arms must meet the following additional inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinna E Lathan, Ph.D | AnthroTronix, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AnthroTronix Inc | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27099613 | Background | 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. |
| Label | URL |
|---|---|
| Website where study is being conducted. Participants register and take their psychological surveys here. | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000544 | Alzheimer Disease |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003704 | Dementia |
| D001927 | Brain Diseases |
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| UNKNOWN |
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| DANA | 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. |
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The PAL assesses visual memory and new learning.
| At baseline and 12 weeks |
| 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 |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |