Social Incentives to Increase Mobility (MOVE IT)
Social Incentives to Increase Mobility Among Hospitalized Patients: The MOVE IT Randomized Trial
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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.
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실험적: 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.
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Participants in the intervention arm will receive social incentives as part of the intervention.
See arm descriptions for more detail.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in mean daily step count from the baseline period to the intervention period, using a wearable pedometer (Nokia Steel) to measure step count.
기간: 13 weeks
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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. .
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13 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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30-day hospital readmission post-discharge, using the state's hospital database
기간: 13 weeks
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A secondary outcome variable is 30-day hospital readmission post-discharge, which will be obtained from the state-based registry.
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13 weeks
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Functional decline from admission to 3 months post-discharge, measured using validated survey assessments.
기간: 13 weeks
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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.
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13 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Mitesh Patel, MD, MBA, MS, University of Pennsylvania
간행물 및 유용한 링크
일반 간행물
- 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.
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Social Incentive에 대한 임상 시험
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University of Campania "Luigi Vanvitelli"완전한
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Loyola Marymount UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)초대로 등록