Health-eBrain Study (HeB)
Caregivers Virtual Health eBrain Study II
연구 개요
상세 설명
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.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Maryland
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Silver Spring, Maryland, 미국, 20910
- AnthroTronix Inc
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention Arm
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.
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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.
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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다른: Waitlist Control Arm
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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from baseline M3 Behavioral Scale score over 12 weeks
기간: At baseline, and 4, 8, and 12 weeks.
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At baseline, and 4, 8, and 12 weeks.
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from baseline Zarit Burden Inventory score over 12 weeks
기간: At baseline, and 4, 8, and 12 weeks.
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At baseline, and 4, 8, and 12 weeks.
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Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks
기간: At baseline, and 4, 8, and 12 weeks.
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At baseline, and 4, 8, and 12 weeks.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Usability Questionnaire
기간: At baseline, and 4, 8, and 12 weeks.
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Survey on using DANA that will help the researchers better understand the development of technologies for this population
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At baseline, and 4, 8, and 12 weeks.
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Paired Associates Learning
기간: At baseline and 12 weeks
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The PAL assesses visual memory and new learning.
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At baseline and 12 weeks
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PERMA Profiler
기간: At baseline and 12 weeks
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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.
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At baseline and 12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Corinna E Lathan, Ph.D, AnthroTronix, Inc.
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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