- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03321279
Social Incentives to Increase Mobility (MOVE IT)
Social Incentives to Increase Mobility Among Hospitalized Patients: The MOVE IT Randomized Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: 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.
|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in mean daily step count from the baseline period to the intervention period, using a wearable pedometer (Nokia Steel) to measure step count.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
30-day hospital readmission post-discharge, using the state's hospital database
Periodo de tiempo: 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.
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mitesh Patel, MD, MBA, MS, University of Pennsylvania
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 826974
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Social Incentive
-
University of PennsylvaniaDeloitteTerminadoObesidadEstados Unidos
-
University of Colorado, DenverUniversity of Alabama at Birmingham; Brown UniversityTerminadoObesidad | Comportamiento alimentarioEstados Unidos
-
University of PennsylvaniaTerminadoObesidad | Tipo II; DiabetesEstados Unidos
-
University of PennsylvaniaPennsylvania Department of HealthTerminado
-
University Hospital, GrenobleLaboratoire de Psychologie et NeuroCognitionAún no reclutandoDesorden del espectro autista
-
VA Office of Research and DevelopmentReclutamientoDepresión | Soledad | AislamientoEstados Unidos
-
Washington University School of MedicineUniversity of Rhode Island; Pwani University; Egerton UniversityActivo, no reclutandoDesnutrición, Niño | Crecimiento; Retraso en el crecimiento, NutricionalKenia
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; Eagles Autism Challenge, IncTerminadoProblema de comportamiento infantil | TEAEstados Unidos
-
San Diego State UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Terminado
-
University of WashingtonTerminadoDemenciaEstados Unidos