Incentives in Cardiac Rehabilitation
23 de março de 2017 atualizado 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.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Antecipado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M4G 2V6
- Recrutamento
- Toronto Rehabilitation Insitute
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Contato:
- Marc Mitchell, PhD
- Número de telefone: 4166607881
- E-mail: marc.mitchell@uhn.ca
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in minutes of objectively measured moderate to vigorous intensity physical activity (MVPA) at 6 months
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from 6 months (intervention end) in minutes of objectively measured MVPA at 12 months
Prazo: 6 months and12 months
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MVPA minutes per week from 6 months to 12 months will be a secondary outcome.
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6 months and12 months
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Change from baseline in Aerobic fitness at 12 months
Prazo: Baseline and12 months
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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.
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Baseline and12 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in Motivation at 6 months and 12 months
Prazo: Baseline, 6 months and12 months
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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
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Enrolment
Prazo: 12 months
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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.
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12 months
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Engagement
Prazo: 12 months
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Level of engagement will be defined as proportion of days ExTracker data submitted.
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12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Paul Oh, MD, University Health Network, Toronto
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2016
Conclusão Primária (Antecipado)
1 de abril de 2018
Conclusão do estudo (Antecipado)
1 de abril de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
13 de outubro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de março de 2017
Primeira postagem (Real)
29 de março de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de março de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de março de 2017
Última verificação
1 de março de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 15-9066
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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