Social Incentives to Increase Mobility (MOVE IT)
Social Incentives to Increase Mobility Among Hospitalized Patients: The MOVE IT Randomized Trial
調査の概要
詳細な説明
This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge. To do this, the investigators will conduct a two-arm randomized, controlled trial during the 3-months after hospital discharge comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program. Patients will be enrolled during hospitalization from medicine and oncology floors into three phases. In phase 1 (hospitalization), patients inpatient step counts will be monitored. In phase 2 (week 1 post-discharge), patients will have a baseline step count estimated. In phase 3 (weeks 2-13 post-discharge), patients will be randomly assigned to the control or intervention group. Patients will be considered enrolled in the trial if they complete the run-in periods (phases 1 and 2) and then are randomized into phase 3.
The enrollment phase will be part of another randomized trial which evaluates the impact of three recruitment strategies on patient enrollment. This trial will be completed and unmasked to patients before they begin the phase 1 of our study.
The investigators will also explore patients' physical activity while in the hospital and if that differs across floors that have or have not deployed a nursing mobility protocol. Changes in patient functional decline and 30-day hospital readmission will also be explored.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
-
-
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:
- Age 18 or older
- Admitted to medicine or oncology floor in the hospital
Exclusion Criteria:
- Inability to provide informed consent
- Does not have daily access to a smartphone compatible with the wearable device
- Already enrolled in another physical activity program
- Inpatient mobility score of 0 or 1 indicating that physical activity is not appropriate for the patient
- Any other medical conditions that would prohibit participation in a 3-month physical activity program
- Unable to complete the run-in phases (e.g. not discharged from the hospital within 60 days of enrolling; not willing to use the wearable device for the 3-month post-discharge intervention).
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:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:Control
Participants' daily step counts will be for weeks 2-13 after hospital discharge.
Participants will be asked to complete surveys at 5, 9 and 13 weeks post-discharge.
|
|
実験的:Intervention
Participants' daily step counts will be monitored for weeks 2-13 after hospital discharge.
Participants will have a weekly step goal that increases from baseline by 10% each week of the intervention (12 weeks).
Participants will engage in a social incentive-based gamification based on points and levels that leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains.
Participants will receive daily feedback for the step counts and weekly feedback for levels.
Participants will be asked to identify a support partner, who will receive weekly reports with the the participant's points and levels balance.
|
Participants in the intervention arm will receive social incentives as part of the intervention.
See arm descriptions for more detail.
|
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 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in mean daily step count from the baseline period to the intervention period, using a wearable pedometer (Nokia Steel) to measure step count.
時間枠:13 weeks
|
The primary outcome variable is the change in mean daily step count from the baseline period (week 1 post-discharge) to the intervention period (weeks 2-13 post-discharge).
This will be measured using the Nokia Steel wearable device. .
|
13 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
30-day hospital readmission post-discharge, using the state's hospital database
時間枠:13 weeks
|
A secondary outcome variable is 30-day hospital readmission post-discharge, which will be obtained from the state-based registry.
|
13 weeks
|
Functional decline from admission to 3 months post-discharge, measured using validated survey assessments.
時間枠:13 weeks
|
A secondary outcome variable is functional decline from admission to 3 months post-discharge, which will be obtained from information collected through validated survey assessments.
|
13 weeks
|
協力者と研究者
捜査官
- スタディディレクター:Mitesh Patel, MD, MBA, MS、University of Pennsylvania
出版物と役立つリンク
一般刊行物
- Greysen SR, Waddell KJ, Patel MS. Exploring Wearables to Focus on the "Sweet Spot" of Physical Activity and Sleep After Hospitalization: Secondary Analysis. JMIR Mhealth Uhealth. 2022 Apr 27;10(4):e30089. doi: 10.2196/30089.
- Greysen SR, Changolkar S, Small DS, Reale C, Rareshide CAL, Mercede A, Snider CK, Greysen HM, Trotta R, Halpern SD, Patel MS. Effect of Behaviorally Designed Gamification With a Social Support Partner to Increase Mobility After Hospital Discharge: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210952. doi: 10.1001/jamanetworkopen.2021.0952.
- Greysen HM, Reale C, Mercede A, Patel MS, Small D, Snider C, Rareshide C, Halpern SD, Greysen SR. Mobility and outcomes for validated evidence - Incentive trial (MOVE IT): Randomized clinical trial study protocol. Contemp Clin Trials. 2020 Feb;89:105911. doi: 10.1016/j.cct.2019.105911. Epub 2019 Dec 12. No abstract available.
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 (実際)
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。
Social Incentiveの臨床試験
-
VA Office of Research and Development募集
-
University of Campania "Luigi Vanvitelli"完了