Depression and Burden in CaregiversHeBNCT02903862
Health-eBrain Study
A study testing Mindoula and DANA in people with Depression and Burden in Caregivers, run by AnthroTronix, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Depression and Burden in Caregivers
- What is being tested?
- Mindoula and DANA
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression and Burden in Caregivers
- Being tested
- Mindoula, DANA
- Keywords
- Caregivers, Case Management, Alzheimer's Disease, Cognition, Caregiver Burden, Depression
- Medical subject headings
- Depression, Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindoulaBehavioural
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.
DANADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindoula; Device: DANA |
| 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. Receives: Device: DANA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline M3 Behavioral Scale score over 12 weeks
Measured: At baseline, and 4, 8, and 12 weeks.
Secondary outcomes (2)
Change from baseline Zarit Burden Inventory score over 12 weeks
Measured: At baseline, and 4, 8, and 12 weeks.
Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks
Measured: At baseline, and 4, 8, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Could not meet enrollment requirement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression and Burden in CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnthroTronix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BrightFocus Foundation, Mindoula Health Inc., 21st Century Brain Trust, Geoffrey Beene Foundation
- Responsible party
- Sponsor
- Investigators
- Corinna E Lathan, Ph.D, Principal investigator, AnthroTronix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903862
- Sponsor's protocol ID
- 091614A
- Acronym
- HeB
- Status last verified
- Jun 2018
- First submitted
- 3 Aug 2016
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27099613
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregivers Virtual Health eBrain Study II
- ClinicalTrials.gov ID
- NCT02903862
- Acronym / sponsor ID
- HeB / 091614A
- Conditions
- Depression and Burden in Caregivers
- Keywords
- Caregivers, Case Management, Alzheimer's Disease, Cognition, Caregiver Burden, Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not meet enrollment requirement.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AnthroTronix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BrightFocus Foundation, Mindoula Health Inc., 21st Century Brain Trust, Geoffrey Beene Foundation
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Mindoula, Device: DANAParticipants 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 | Device: DANAThese 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindoulaThe 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. | Behavioural | Intervention Arm |
| DANADANA 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. | Device | Intervention Arm, Waitlist Control Arm |
Primary outcome
Change from baseline M3 Behavioral Scale score over 12 weeks
Time frame: At baseline, and 4, 8, and 12 weeks.
2 secondary outcomes
Change from baseline Zarit Burden Inventory score over 12 weeks
Time frame: At baseline, and 4, 8, and 12 weeks.
Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks
Time frame: At baseline, and 4, 8, and 12 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Background: PubMed 27099613Lathan 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.
- Website where study is being conducted. Participants register and take their psychological surveys here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinna E Lathan, Ph.D principal investigator
AnthroTronix, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindoula and DANA in people with Depression and Burden in Caregivers, run by AnthroTronix, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline M3 Behavioral Scale score over 12 weeks (time frame: At baseline, and 4, 8, and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02903862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.