入院を抑制するためのウェアラブル活動追跡 (WATCH)
入院を抑制するためのウェアラブル活動追跡 (WATCH)
This study is being done to collect patient generated health data to predict the risk of patients needing emergency department visits or hospitalization before, during. and after receiving radiation therapy.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
PRIMARY OBJECTIVE:
I. Validate a previously developed step-count model for predicting all-cause acute care (pooled across all devices).
SECONDARY OBJECTIVES:
I. Validate a previously developed model for predicting each ED visits or hospitalizations during external beam RT using continuous step counts before, during, and after treatment.
II. Validate the previously developed step-count model for predicting all-cause acute care for each of the two different device platforms.
III. Validate concordance of step counts across each of the device's platforms in the Apple group.
IV. Validate the previously developed SHIELD-RT Electronic health record (EHR)-based model for predicting unplanned acute care (ED visit or hospitalization).
EXPLORATORY OBJECTIVES:
I. Refinement of the pre-existing models(step count and SHIELD-RT). II. Evaluate association between wearables collected parameters, EHR-based variables, and acute care events.
III. Develop and validate a multi-modal predictive model for predicting acute care.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
- GROUP I: Participants receive Fitbit device and undergo non-interventional, standard of care, radiation therapy.
- GROUP II: Participants receive Fitbit device and utilize their own personal Apple HealthKit-based device and undergo non-interventional, standard of care, radiation therapy.
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前:Imani Dunn
- 電話番号:877-827-3222
- メール:Imani.Dunn@ucsf.edu
研究場所
-
-
California
-
San Francisco、California、アメリカ、94143
- 募集
- University of California, San Francisco
-
コンタクト:
-
主任研究者:
- Julian Hong, MD, MS
-
コンタクト:
- Imani Dunn
- 電話番号:877-827-3222
- メール:Imani.Dunn@ucsf.edu
-
-
参加基準
適格基準
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
サンプリング方法
調査対象母集団
Adult patients undergoing non-interventional, standard of care, radiotherapy (RT) at UCSF Department of Radiation Oncology
説明
Inclusion Criteria:
- Age >= 18.
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky Performance Scale (KPS) >= 50%.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- Diagnosis of invasive malignancy.
- Able to ambulate independently (without the assistance of a cane or walker).
- Planned treatment with fractionated external beam radiotherapy over at least 5 days (no fractional requirement).
- Not a previous participant on this protocol for subsequent courses.
Exclusion Criteria:
- Participants bound to a wheelchair.
- Participants unable to ambulate independently (needing assistance of cane or walker).
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
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
Observational Group I: Fitbit only
Participants receive Fitbit device while undergoing non-interventional, standard of care, radiation therapy. |
Participants will wear Fitbit device
他の名前:
|
|
Observational Group II: Fitbit + Apple HealthKit
Participants receive Fitbit device and will utilize personal Apple HealthKit-based devices (iPhone, Apple Watch, etc.) to concurrently contribute Apple HealthKit-based data while undergoing non-interventional, standard of care, radiation therapy. |
Participants will wear Fitbit device
他の名前:
Participants will wear personal device and share data with study team.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Area under the receiver operating characteristic curve (AUC-ROC) of the step count model
時間枠:Up to 3 years
|
The AUC-ROC of the step count model will measure the performance of a classification model by plotting the rate of true positives against false positives, and the score ranges from 0 - 1. The higher the AUC, the better the model's performance at distinguishing between the positive and negative classes. The AUC-ROC will be reported including both estimates and confidence intervals. All models will be reported per up-to-date guidelines, such as Minimum Information about Clinical Artificial Intelligence Modeling (MI-CLAIM) and Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD). The performance metrics will only be calculated with respect to first acute care event. |
Up to 3 years
|
|
Calculation of a Brier Score
時間枠:Up to 3 years
|
The Brier Score is a strictly proper score function or strictly proper scoring rule that measures the accuracy of probabilistic predictions. A Brier Score can take on any value between 0 and 1, with 0 being the best score achievable and 1 being the worst score achievable. The lower the Brier Score, the more accurate the prediction(s). The score will be reported including both estimates and confidence intervals. All models will be reported per up-to-date guidelines, such as MI-CLAIM and TRIPOD. The performance metrics will only be calculated with respect to first acute care event. |
Up to 3 years
|
|
Calculation of Log-Loss Score
時間枠:Up to 3 years
|
Logarithmic loss indicates how close a prediction probability comes to the actual/corresponding true value. The Log-Loss Score can take on any value between 0 and 1. The more the predicted probability diverges from the actual value, the higher is the log-loss value. The log-loss value will be reported including both estimates and confidence intervals. All models will be reported per up-to-date guidelines, such as MI-CLAIM and TRIPOD. The performance metrics will only be calculated with respect to first acute care event. |
Up to 3 years
|
|
Area Under the Precision-Recall Curves (AUCPR)
時間枠:Up to 3 years
|
The area under the precision-recall curve (AUCPR) is a single number summary of the information in the precision-recall (PR) curve. It represents the tradeoff between precision and recall for different thresholds, where high AUCPR indicates both high recall and high precision. The AUCPR will be reported including both estimates and confidence intervals. All models will be reported per up-to-date guidelines, such as MI-CLAIM and TRIPOD. The performance metrics will only be calculated with respect to first acute care event. |
Up to 3 years
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AUC-ROC for composite acute care
時間枠:Up to 3 years
|
The AUC-ROC will be used to validate a previously developed model in the primary endpoint for predicting each ED visits or hospitalizations during external beam RT using continuous step counts before, during, and after treatment. |
Up to 3 years
|
|
Area under the receiver operating characteristic curve (AUC-ROC) for all cause acute care by group
時間枠:Up to 3 years
|
The AUC-ROC will be used to validate the previously developed step-count model in the primary endpoint for predicting all-cause acute care for each of the two different device platforms. |
Up to 3 years
|
|
Mean squared error (MSE)
時間枠:Up to 3 years
|
The MSE will be used to validate concordance of step counts across each of the device's platforms in the Apple group. Mean Squared Error (MSE) is a fundamental concept in statistics and machine learning in assessing the accuracy of the predictive models which measures the average squared difference between predicted values and the actual values in the dataset. |
Up to 3 years
|
|
Area under the receiver operating characteristic curve (AUC-ROC) for the composite acute care endpoint..
時間枠:Up to 3 years
|
Validate the previously developed SHIELD-RT EHR-based model for predicting unplanned acute care (ED visit or hospitalization) to discover additional variables which may be predictors not previously included. |
Up to 3 years
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Julian Hong, MD, MS、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 23722
- NCI-2024-06762 (レジストリ識別子:NCI Clinical Trial Reporting Program (CTRP))
- R01CA277782 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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