Incentives in Cardiac Rehabilitation
23 de marzo de 2017 actualizado por: Paul Oh, University Health Network, Toronto
A Web-based Exercise Intervention With Financial Incentives for Cardiac Rehabilitation Graduates: A One Year Crossover Study Design
The objective of this study is to examine whether a financial incentive program increases minutes of moderate-to-vigorous physical activity (MVPA) per week among cardiac rehabilitation (CR) graduates.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
A 52-week, randomized, crossover study design will be employed to examine the impact of financial incentives on MVPA among cardiac rehabilitation (CR) program graduates. Two experimental therapies, (1) online self-monitoring plus 'virtual rewards' (i.e. badges) (ExTrack.ca) and (2) online self-monitoring plus 'financial incentives' (ExTracker.ca), will be administered for six months, one after the other.
Study participants will be randomly assigned (1:1) to receive these therapies in one of two orders: Group A will receive ExTrack.ca (virtual rewards) for six months, followed by ExTracker.ca (financial incentives) for the next six months; Group B will receive the financial incentive condition first, and the virtual rewards condition second. While exposed to the incentive condition, participants will be eligible to earn financial reward per day exercise is tracked.
This study design allows for the assessment of 'real world' uptake of an incentive program among CR patients, since both Groups A and B will be able to earn incentives. This design will also help determine if incentives sustain MVPA in the first six months post-CR compared with the virtual rewards condition. Finally, the crossover design will allow the exploration of incentive 'timing' - that is, figuring out if incentives more effectively sustain MVPA post-CR if they are offered immediately, versus six months after graduation when patient motivation tends to wane.
In addition to tracking exercise sessions using the online self-monitoring tool, participants will be asked to record steps per day, and 10-minute MVPA bouts per day, using a StepsCount accelerometer. To check the accuracy of participant entries, participants will be asked to mail-in their accelerometers at the study mid- and end-points (26 and 52 weeks, respectively). Participants will also be asked to complete the Behavioural Regulation to Exercise Questionnaire (BREQ-3) at baseline (T1), study mid-point/crossover (T2), and study end-point (T3) as well as cardiopulmonary fitness assessments at T1 and T3.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Marc Mitchell, PhD
- Número de teléfono: 4166607881
- Correo electrónico: marc.mitchell@uhn.ca
Copia de seguridad de contactos de estudio
- Nombre: Golnoush Taherzadeh, MSc
- Número de teléfono: 4169183852
- Correo electrónico: gtaherza@uhnresearch.ca
Ubicaciones de estudio
-
-
Ontario
-
Toronto, Ontario, Canadá, M4G 2V6
- Reclutamiento
- Toronto Rehabilitation Insitute
-
Contacto:
- Marc Mitchell, PhD
- Número de teléfono: 4166607881
- Correo electrónico: marc.mitchell@uhn.ca
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- CR program graduate (actively participating in program in month six, the final month, of the CR program).
Exclusion Criteria:
- No internet access
- Non-English speaking
- Diagnosed cognitive disorder
- Participating in another post-CR intervention study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Self-monitoring (financial incentives then virtual rewards)
Participants will be asked to track their exercise daily, using an online tool called ExTracker.ca,
for 52 weeks.
Date, type of exercise, time spent exercising, and distance covered will be self-reported, as will steps per day and 10-minute bouts of MVPA per day (measured by an accelerometer).
In the first six months, participants will earn financial incentive (ex.
grocery vouchers) each day exercise is tracked.
In the second six months, participants will earn virtual rewards (i.e.
heart badges) each day exercise is tracked.
|
All participants will have access to a web-based exercise tracking tool called ExTracker.
Individuals will be asked to submit their exercise diaries daily for 52 weeks, using the ExTracker program.
Upon entering exercise information, participants will receive individual (e.g., You've completed 50% of your exercise sessions this week!) and group-level (e.g., You and the other people in this study are walking across Canada!
Next stop - Toronto!) feedback.
Should participants cease to use the platform for one week, they will receive an email reminder to re-engage with the platform.
Three such emails will be sent to lapsing participants.
All participants will be asked to wear the StepsCount Piezo accelerometer, and track the steps per day and bout minutes of MVPA per day measured by the device.
Additionally, participants will be mailed an accelerometer (and asked to return their used ones) at study weeks 26 and 52 in order for the researcher to confirm the data inputted into the ExTracker from the device.
Participants will earn financial incentives each day they track their exercise, for the first six months of the study.
In the second six months, participants will "crossover" to the other therapy, the 'virtual rewards' therapy, for six months.
|
|
Comparador activo: Self-monitoring (virtual rewards then financial incentives)
Participants will be asked to track their exercise daily, using an online tool called ExTrack.ca, for 52 weeks.
Date, type of exercise, time spent exercising, and distance covered will be self-reported, as will steps per day and 10-minute bouts of MVPA per day (measured by an accelerometer).
In the first six months, participants will earn virtual rewards (i.e.
heart badges) each day exercise is tracked.
In the second six months, participants will earn financial incentive (ex.
grocery vouchers) each day exercise is tracked.
|
All participants will have access to a web-based exercise tracking tool called ExTracker.
Individuals will be asked to submit their exercise diaries daily for 52 weeks, using the ExTracker program.
Upon entering exercise information, participants will receive individual (e.g., You've completed 50% of your exercise sessions this week!) and group-level (e.g., You and the other people in this study are walking across Canada!
Next stop - Toronto!) feedback.
Should participants cease to use the platform for one week, they will receive an email reminder to re-engage with the platform.
Three such emails will be sent to lapsing participants.
All participants will be asked to wear the StepsCount Piezo accelerometer, and track the steps per day and bout minutes of MVPA per day measured by the device.
Additionally, participants will be mailed an accelerometer (and asked to return their used ones) at study weeks 26 and 52 in order for the researcher to confirm the data inputted into the ExTracker from the device.
Participants will earn 'virtual rewards' (i.e. a heart badge) each day they track their exercise, for the first six months of the study.
In the second six months, participants will "crossover" to the other therapy, the 'financial incentive' therapy, for six months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in minutes of objectively measured moderate to vigorous intensity physical activity (MVPA) at 6 months
Periodo de tiempo: Baseline and 6 months
|
The primary outcome of this trial will be minutes of objectively assessed MVPA per week measured by StepsCount Piezo accelerometers from baseline to 6 months.
|
Baseline and 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 months
Periodo de tiempo: 6 months and12 months
|
MVPA minutes per week from 6 months to 12 months will be a secondary outcome.
|
6 months and12 months
|
|
Change from baseline in Aerobic fitness at 12 months
Periodo de tiempo: Baseline and12 months
|
Aerobic fitness will be a secondary outcome as well, measured by symptom limited exercise stress test at baseline and 12 months, given its strong and graded (inverse) associations with cardiovascular disease-related outcomes.
|
Baseline and12 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in Motivation at 6 months and 12 months
Periodo de tiempo: Baseline, 6 months and12 months
|
Participants will also be asked to complete a 23-item questionnaire designed to measure self-determined motivation to exercise (the BREQ-3) (Wilson et al. 2006) at Baseline, 6 months, and 12 months.
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Baseline, 6 months and12 months
|
|
Enrolment
Periodo de tiempo: 12 months
|
Study recruitment rate will be calculated by dividing the number of consenting CR patients by the number of eligible CR graduates who were recruited to participate in the study.
|
12 months
|
|
Engagement
Periodo de tiempo: 12 months
|
Level of engagement will be defined as proportion of days ExTracker data submitted.
|
12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Paul Oh, MD, University Health Network, Toronto
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2016
Finalización primaria (Anticipado)
1 de abril de 2018
Finalización del estudio (Anticipado)
1 de abril de 2018
Fechas de registro del estudio
Enviado por primera vez
13 de octubre de 2016
Primero enviado que cumplió con los criterios de control de calidad
23 de marzo de 2017
Publicado por primera vez (Actual)
29 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de marzo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
23 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-9066
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .
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