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- Ensaio Clínico NCT01495780
eRT Remote Health Monitoring
Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT).
Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will participate in RHM. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA David Geffen School of Medicine
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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:
- Age >40 years.
- Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9
- Smoking history >10 pack-years.
- Postbronchodilator FEV1/FVC<70% and FEV1<70% based on NHANES III reference values
- Domestic situation felt to be supportive of remote health monitoring.
- Ability to give informed consent.
Exclusion Criteria:
- Clinical diagnosis of asthma.
- Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction.
- Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke).
- Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit.
- Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial.
- Myocardial infarction within 6 weeks of enrolment.
- Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day.
- A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Remote Health Monitoring
Subjects assigned to this arm will conduct daily at-home health monitoring using several electronic devices that will transmit data back to the study team.
Everyday, subjects will measure pulse oximetry (SpO2) using a finger clip, answer questions about symptoms and medication use, answer a quality of life questionnaire, perform breathing tests, and record physical activity (using a physical activity monitor that will be mailed to the study team).
Wearing the activity monitor is optional and will only occur during months 1, 6, and 12.
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1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Compliance with daily RHM
Prazo: 1 year
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Compliance with daily RHM as a percentage of study days
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1 year
|
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Integrity of spirometric data
Prazo: 1 year
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Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability.
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Número de consultas médicas
Prazo: 1 ano
|
1 ano
|
|
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Rate of adoption of RHM
Prazo: 1 year
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Time it takes for subjects to become compliant with daily RHM
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1 year
|
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Treatment adherence
Prazo: 1 year
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Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician)
|
1 year
|
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Time to first COPD exacerbation
Prazo: 1 year
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Time to first COPD exacerbation as defined by standard criteria.
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1 year
|
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Number of COPD exacerbations per year
Prazo: 1 year
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1 year
|
|
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Proportion of subjects experiencing one or more exacerbations
Prazo: 1 year
|
1 year
|
|
|
Mean daily FEV1
Prazo: 1 year
|
1 year
|
|
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Mean daily IC
Prazo: 1 year
|
1 year
|
|
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Mean daily activity level
Prazo: 1 year
|
1 year
|
|
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Mean daily SpO2
Prazo: 1 year
|
1 year
|
|
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Daily symptom scores
Prazo: 1 year
|
1 year
|
|
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Number of emergency department visits
Prazo: 1 year
|
1 year
|
|
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Number of hospitalizations
Prazo: 1 year
|
1 year
|
|
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Number of days spent in hospital
Prazo: 1 year
|
1 year
|
|
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Health care costs
Prazo: 1 year
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Inferred health care costs using a standard cost framework model
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- eRT RHM
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