- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01678183
Financial Incentives for Medication Adherence (FIMA)
This study is a pilot study. The investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that many patients do not take their medications as prescribed by their doctors. This contributes to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and death. The investigators hypothesize that use of a financial incentive will motivate patients to improve their medication adherence and ultimately their control of their chronic diseases.
The investigators plan to identify patients who get Primary Care at Boston Medical Center who still have high blood sugars more than a year after their diabetes diagnosis, and randomize them to a control arm, or one of two intervention arms. Subjects will be approached at the time of a regularly-scheduled appointment with their Primary Care doctor and offered the opportunity to participate in the study. All subjects who agree to participate in the study will meet with a Clinical Pharmacologist to review their medications in detail, and then undergo randomization. Subjects in the first intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month. Subjects in the second intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators will enroll a total of 100 subjects in the study, and anticipate an observational cohort of approximately 1,000 patients.
All patients who are eligible for the study but who are not enrolled in the study and have not declined to participate in the study will become the observational cohort for the study. The observational cohort will be used to determine whether randomization to the control arm of the study has a negative, rather than neutral, effect on patients.
At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to have their blood pressure checked and to have their blood drawn so that their blood sugar and cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel, systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and macrovascular complications, and death.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age greater than or equal to 18 years
- Speaks English, Spanish, or Haitian Creole
- Established patient in Boston Medical Center Section of General Internal Medicine Primary Care Practice
- Uses Boston Medical Center Pharmacy
- Diagnosed with diabetes for more than one year
- Prescribed medications for diabetes
- Last hemoglobin A1c > 7.9
Exclusion Criteria:
- Pregnant
- History of Brittle Diabetes
- Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Monthly Incentive
Subjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension, and hypercholesterolemia at the pharmacy on time.
The intervention is the cash incentive.
|
A cash payment.
|
Experimental: Monthly and Final Incentive
Subjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension and hypercholesterolemia at the pharmacy on time, as well as an additional financial incentive for each full percentage point of decrease in their hemoglobin A1c over the eight-month course of the study.
The two cash incentives are the intervention.
|
A cash payment.
One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.
|
Sem intervenção: Control
These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Improvement in hemoglobin A1c
Prazo: 8 months
|
The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
|
8 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Improvement in blood pressure.
Prazo: Eight months
|
The investigators will assess blood pressure measurements at the start and end of the study.
|
Eight months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Lipid levels
Prazo: Eight months
|
The investigators will assess lipid levels at the start and end of the study.
|
Eight months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elizabeth Rourke, MD, Boston Medical Center
- Investigador principal: Amitabh Chandra, Ph.D., Harvard Kennedy School, National Bureau of Economic Research
- Investigador principal: Katherine Baicker, Ph.D., Harvard School of Public Health, National Bureau of Economic Research
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BU IRB H-30045
- WS2069417 (Número de outro subsídio/financiamento: Pfizer)
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