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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02035566
Telehome Monitoring for Chronic Disease Management
Effectiveness of Telehome Monitoring on Quality of Life and Health Resources Utilization Among People With Chronic Disease Residing in Rural Maryland
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
While the nation's overall health status has improved over the past decade, disparities persist among racial/ethnic minorities, low-income whites, the medically under-served, and rural residents. The disparities in disease morbidity and mortality are a compelling crisis and the elimination of such disparities is a national priority. With an aging population, the changing demographics are increasing the disease burden attributable to chronic diseases.
The broad goal of this project is to evaluate the potential value of using THC technology in chronically ill patients in rural Maryland, within the broad context of social determinants of health. This builds upon a completed pilot research study in Garrett County on a small scale THC program in rural Garrett County Maryland funded by the Maryland Cigarette Restitution Fund (CRF) supported Other Tobacco Related Diseases (OTRD grant) (CBaquet PI) in collaboration with the division of cardiology and department of family medicine. This research study will look at whether the THC equipment in the home for 60 days will make a difference in the health of the patients who get the unit in their home compared to the patients who will not receive the unit for 60 days. And we will look at whether this technology will support patient monitoring in the home. The use of the technology will be evaluated to determine whether patient monitoring using THC equipment will influence the hospitalization rates or emergency department visits for the patients. Evaluation of the influence of the THC equipment on medical resource utilization in rural and medically underserved communities will be studied.
Telehome care (THC) may provide augmentation to current face to face monitoring through home visits (usual method for Center for Medicaid and Medicare Services (CMS) billable home health services) of chronically ill patients and may provide an innovative and potentially cost-effective solution to improving patients' outcomes and health care resource utilization in rural areas. THC can support the coordination of care by assessing and monitoring patients in their homes and giving health care providers appropriate feedback to assure patient compliance with discharge instructions such as medication, home care and other aspects of recommended treatment regimens. Further, THC may improve service coordination at discharge and provide ongoing monitoring/engagement of patients, which is considered essential to prevent re-hospitalizations and emergency department visits. Demonstration of the potential benefits on care pathways, and patient and provider acceptance and satisfaction with the technology requires systematic larger scale and scientifically rigorous studies.
Purpose The project's broad goals are to evaluate the effects of telehome care (THC), a form of remote patient home monitoring,(within the broad context of social determinants of health) for chronic disease management among rural residing minority, low-income white, and medically underserved patients by: (a) providing an innovative telehome care (THC) capacity and infrastructure in two Maryland rural and medically underserved communities; and (b) using the THC infrastructure to generate scientifically rigorous and high quality evidence on whether the THC technology improves patient monitoring, influences clinical outcomes, and has an impact on medical resource utilization. [NOTE: THC uses telecommunication technologies to enable home health agency clinical staff at a rural home health agency to monitor their patients in the home.]
The major aim for this study are: 1) To evaluate the impact of the 60-day in home THC monitoring on medical resource utilization (emergency department visits; re-hospitalization rates) and Quality of Life related to the management of Metabolic Syndrome/Diabetes Mellitus (DM), Chronic Heart Failure (CHF), Hypertension (HTN), and Chronic Obstructive Pulmonary Disease (COPD) compared to those patients that receive only an educational pamphlet. Secondary aim hopes to support patient education to enhance acceptability, patient independence and satisfaction.
In this study, remote in-home patient monitoring using a THC system from VitelNet (telehealth equipment vendor) will provide patient monitoring remotely or non billable services for the experimental study arm for this project in addition to routine billable home health services. This project does not substitute billable in-home monitoring of patients which is a prerequisite for enrollment into this study(conventional home health services) but provides remote monitoring for the study arm in addition to conventional/billable services delivered.
Patients are randomized to either THC use for 60 days with 60, 90 day follow up or "usual care" with 60, 90 day follow up.
In addition, new knowledge will be generated by this study on methods for conduct of health disparities research and training of non-research clinical personnel who are community based in data collection and research ethics.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Maryland
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Hughesville, Maryland, Estados Unidos, 20637
- Chesapeake-Potomac Home Health Agency
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Oakland, Maryland, Estados Unidos, 21550
- Garrett County Health Department Home Health Agency
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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:
- Home bound at a home health agency (i.e., Garrett County Health Department Home Health Agency or Chesapeake-Potomac Home Health Agency)
- Clinical diagnosis of at least one of the following: chronic obstructive pulmonary disease, chronic heart failure, uncontrolled hypertension, diabetes mellitus and taking anti-hyperglycemic oral therapy
- Able to operate the telehome care system
- Agreeable to have the telehome care system installed at residence for 60 days
- Residing in an environment where care can be provided safely
Exclusion Criteria:
- Not eligible for home health care
- With a clinical diagnosis of a medical condition other than obstructive pulmonary disease, chronic heart failure, uncontrolled hypertension, diabetes mellitus and taking anti-hyperglycemic oral therapy
- Unable to follow instructions about or be able to operate the telehome care system
- Residing in an environment that is unsafe to provide home health care
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Cuidados usuais
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Experimental: Telehome Care Monitoring + Usual Care
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Telehome care monitoring over a 60-day period wherein patients transmit health measurements to their health care professional on a daily basis
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Self reported Quality of life
Prazo: The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline
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Assessing change from baseline to 90 day evaluated.
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The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline
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Number of emergency department visits
Prazo: The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline
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Assessing change from baseline to 90 day post baseline for:
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The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline
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Re-hospitalization
Prazo: Assessing change from baseline and 90-day post-baseline
|
Assessing change from baseline to 90 day post baseline for:
|
Assessing change from baseline and 90-day post-baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of contacts (visits or phone calls) with health care providers
Prazo: Assessing change from baseline and 90-day post-baseline
|
Assessing change from baseline and 90-day post-baseline
|
|
Adequacy of hypertension control
Prazo: Measures change from baseline and 90-day post-baseline
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Measures change from baseline to 90 day post baseline for:adequacy of blood pressure control (<140/90 mmHg)
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Measures change from baseline and 90-day post-baseline
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Adequacy of diabetes control
Prazo: Measures change from baseline and 90-day post-baseline
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adequacy of glycemic control of HbA1C of <7.5
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Measures change from baseline and 90-day post-baseline
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Compliance with recommended (by discharging physician/primary health professional) drug therapy use for heart failure
Prazo: Assessing change from baseline and 90-day post-baseline
|
Assessing change from baseline and 90-day post-baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Claudia R Baquet, MD MPH, University of Maryland School of Medicine
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 (Real)
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
- HP-00044150
- RC2MD004800 (Concessão/Contrato do NIH dos EUA)
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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