- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02599259
Using Artificial Intelligence to Measure and Optimize Adherence in Patients on Anticoagulation Therapy.
Using Artificial Intelligence on Mobile Devices to Automate Directly Observed Therapy (DOT), Confirm Medication Ingestion, and Optimize Treatment in Patients on Anticoagulation Therapy.
Visão geral do estudo
Descrição detalhada
This study will employ a single-site, parallel-arm, and randomized trial design. A total of 50-100 human subjects- who have a diagnosis of ischemic stroke and taking any one of the following oral anticoagulant medication- Coumadin® (warfarin), Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban) will be recruited for the study. All participants will receive their doctor's treatment-as-usual. 1:1 randomization will be done at baseline, those in the +arm will have their medication adherence monitored by means of the AiCure platform, and the other participants will be assigned to the control arm of the study.
Study visits include a screening visit, one or two baseline visits (which ideally will occur between 7 and 14 days after the screening visit), and monthly visits for the 12 weeks following the last baseline visit. Randomization will occur during the final baseline visit. During the final baseline visit, patients assigned to the AiCure intervention arm will be provided training on the AiCure platform. While in the clinic, the participants will practice using the AiCure app by going through a detailed tutorial that consists of a number of interactive training steps. Participants will use a substitute placebo practice medication in order to complete the training tutorial.
Study participants will be reimbursed to cover their time and transportation costs in accordance with Institutional Review Board (IRB) guidelines.
For the length of the study, participants assigned to the AiCure intervention arm of the study will be requested to take each dose of their prescribed medication regimen using the AiCure app. Data from each dosing event will be saved onto the participant's device and encrypted data (including de-identified video and time and date of administration) will be automatically transmitted to the centralized dashboard. If the study participant takes a dose but does not use the AiCure app (self-reports by confirming administration over the phone to a Study Coordinator or manually self-reports on the AiCure App without going through the necessary steps), misses a dose (participant fails to take dose prior to 'time for next dose' message appears on the device), or uses the AiCure app incorrectly (usability error or suspicious behavior), the Study Coordinator and/or the AiCure team will intervene as detailed in the escalation protocol.
Real-time adherence data will be automatically transmitted to the cloud-based centralized dashboard for the intervention group. All subjects will have INR and DRVVT measured once a month (or more frequently if on warfarin) to monitor medication adherence using a point of care device and/or laboratory monitoring (upon Principal Investigator and hematologist's discretion) at the clinic visit. All participants will get their prescription refills at their monthly visits. In addition, pill counts will be done for all participants. If adherence is sub-optimal based on pill count, the study coordinator will document the participant's self-reported reasons for sub-optimal adherence. In addition, participants in the intervention group will have their AiCure adherence rates reviewed by the assessing research staff, and any reasons provided by the subject for sub-optimal adherence will be recorded.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
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New York, New York, Estados Unidos, 10467
- Montefiore Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Is male or female at least 18 years of age.
- Having a diagnosis of ischemic stroke.
- Has a score between 1 and 20 on the NIH Stroke Survey (NIHSS) at admission and upon enrollment at discharge from the index admission to the hospital or at first encounter in the outpatient stroke center.
- Is taking any one of the monitored drugs- Coumadin®, Pradaxa®, Xarelto® or Eliquis®.
- Is going home or to acute outpatient rehabilitation after discharge.
- Has sufficient capacity to provide consent or agree to assent.
- Has at least minimal mental capacity and motor skills.
Exclusion Criteria:
- Has poor fine motor skills, to preclude him/her from holding a pill steady in front of a camera.
- Has impaired visual or auditory faculties.
- Is being released to a nursing home, hospice or any other inpatient care facility.
- Has stable, therapeutic INRs on warfarin for at least one year.
- Has a mechanical mitral valve or left ventricular assist device.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 1. Monitored (M+)
Group receiving treatment as usual (TAU) and using the AiCure platform for monitoring and intervention platform on a mobile device being tested when taking their daily anticoagulation medication.
|
Patients assigned to the intervention arm will use the AiCure Platform to monitor ingestion of all prescribed doses of oral anticoagulants.
If a patient misses a dose, takes an incorrect dose, or their data are flagged for suspicious activity, they will be contacted by the Study Coordinator or AiCure study team.
Outros nomes:
|
Sem intervenção: Unmonitored (M-)
No Intervention.
Group receiving TAU and not issued mobile device with the AiCure platform.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
To evaluate acceptability and likability of the platform to patients and providers in providing real-time adherence monitoring.
Prazo: 12 Weeks
|
Assess sustainability over 12 weeks by comparing number of prescribed doses to number of doses taken using the device.
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12 Weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Improved self-efficacy rates as measured by the SEAMS and BMQ questionnaires, administered at baseline and at the end of the study.
Prazo: 12 Weeks
|
Improved self-efficacy rates as measured by the SEAMS and BMQ questionnaires, administered at baseline and at the end of the study.
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12 Weeks
|
Optimized treatment models based on regular monitoring of INR in desired target range of 2 - 3 and DRVVT in combination with real-time adherence data from the Automated DOT® platform
Prazo: 12 Weeks
|
Maintenance of target INR of 2 to 3 in a stroke population taking oral anticoagulants.
|
12 Weeks
|
Optimized treatment models based on regular monitoring of INR and DRVVT in combination with real-time adherence data from the Automated DOT® platform.
Prazo: 12 Weeks
|
Maintenance of target DRVVT within a predetermined range by a stroke population taking oral anticoagulants.
|
12 Weeks
|
Evaluate acceptability and utility through qualitative questionnaires.
Prazo: 12 weeks
|
Evaluate acceptability and utility through qualitative questionnaires.
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Adam Hanina, MBA, AiCure
- Investigador principal: Daniel Labovitz, MD, Montefiore Medical Center
Publicações e links úteis
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AI-007.2
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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