Health-eBrain Study (HeB)
Caregivers Virtual Health eBrain Study II
調査の概要
詳細な説明
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.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
-
-
Maryland
-
Silver Spring、Maryland、アメリカ、20910
- AnthroTronix Inc
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
他の：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from baseline M3 Behavioral Scale score over 12 weeks
時間枠：At baseline, and 4, 8, and 12 weeks.
|
At baseline, and 4, 8, and 12 weeks.
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from baseline Zarit Burden Inventory score over 12 weeks
時間枠：At baseline, and 4, 8, and 12 weeks.
|
At baseline, and 4, 8, and 12 weeks.
|
|
Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks
時間枠：At baseline, and 4, 8, and 12 weeks.
|
At baseline, and 4, 8, and 12 weeks.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Usability Questionnaire
時間枠：At baseline, and 4, 8, and 12 weeks.
|
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
時間枠：At baseline and 12 weeks
|
The PAL assesses visual memory and new learning.
|
At baseline and 12 weeks
|
|
PERMA Profiler
時間枠：At baseline and 12 weeks
|
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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Corinna E Lathan, Ph.D、AnthroTronix, Inc.
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。