- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03398772
Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.
Effects of a Comprehensive Health Coaching Program on Lung Function, Exercise Tolerance, Symptom Distress, Quality of Life, Readmission, and Survival in Advanced Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial.
Chronic obstructive pulmonary disease due to incurable and prevalence has increased steadily, chronic respiratory disease is considered hazardous to health and quality of life of the disease. GOLD treatment guidelines (global initiative for chronic obstructive lung disease guideline) pointed out the pulmonary rehabilitation is one of the non-drug treatment in patients with severe COPD, shown to improve exercise capacity and reduce the short of breathing, improve the quality of life and reduce the anxiety associated and depression and improved survival advantages. Meanwhile, a few studies have examined effect the exercise training in severe COPD patients' symptom distress and quality of life, so as to make severe COPD patients to improve the effectiveness of the campaign to ongoing regular pulmonary rehabilitation movement, is considered an important issue.
It has been proposed that physical activity enhancement or exercise training can be effective in improving symptoms and quality of life in these patients. However, it has not been examined systematically. Therefore, the main purposes of this study are: 1.Prevalence of symptom distress; 2.The physical preferences; 3.The relationship between quality of life and physical activity; 4.Effects of Comprehensive Health coaching exercise training on improving fatigue, sleep disturbances, quality of life, readmission, and survival. In the first year of this study, a descriptive-correlational design will be used and in the second and third years of study, the experimental design and prospective longitudinal study will be undertaken. Instruments include motion sensors, physical activity scale, Physical Activity Preferences, Pittsburgh Sleep Quality of Life Index. Statistical analyses include descriptive statistics, t-test, one-way ANOVA, latent growth modeling, Logistic models, GEE, and survival analysis. Results from this study will provide important implications for improving symptom management and quality of life for sever chronic obstructive pulmonary disease patients.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Taipei, Taiwan
- Recrutamento
- Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare
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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 and ≦80 years
- patients with advanced COPD are defined according to the diagnostic criteria for severe (GOLD 3) and very severe (GOLD 4)
- pulmonologist assess need pulmonary rehabilitation, but not accept any rehabilitation exercise program.
- pulmonologist assessment the patients with a stable state.
- awareness, has the ability to read, write, and communication.
- willing to communicate by phone, and can operate smart phones.
Exclusion Criteria:
- COPD AE requiring corticosteroids, antibiotics, emergency room visit or hospitalization within the past 3 month.
- diagnosed mentally or cognitive disorder, such as dementia or unable to cooperate.
- severe hip, knee disease, can not perform exercise, or with neuromuscular dysfunction, such as limb hemiplegia, no independent walking function or other deterioration due to bone and joint disease.
- combined with severe heart disease, such as AMI, severe arrhythmia or heart failure.
- current regular practice of physical activity
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Experiment
Comprehensive Health Coaching Program
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Comprehensive Health Coaching Program: included physical activity and motivational interviewing techniques, participants were encouraged to set goals with decision-making, self-management and self-monitor their progress, and received support from researcher.
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Sem intervenção: Control
Guideline-based usual care
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline Lung function at 3 months, 6months
Prazo: 3 months, 6months
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Spirometry (FEVl % predicted )
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3 months, 6months
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Change from Baseline Exercise Tolerance at 3 months, 6months
Prazo: 3 months, 6months
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6 Minute walking test
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3 months, 6months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline Health-related quality of life at 3 months, 6months
Prazo: 3 months, 6months
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St. George's Respiratory Questionnaire
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3 months, 6months
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Change from Baseline Fatigue at 3 months, 6months
Prazo: 3 months, 6months
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Brief Fatigue Inventory Short Form BFI-Taiwan Form
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3 months, 6months
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Change from Baseline Psychological distress at 3 months, 6months
Prazo: 3 months, 6months
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Hospital Anxiety and Depression Scale
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3 months, 6months
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Change from Baseline Symptom Distress at 3 months, 6months
Prazo: 3 months, 6months
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Taiwanese version of the M. D. Anderson Symptom Inventory
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3 months, 6months
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Change from Baseline Quality of Sleep at 3 months, 6months
Prazo: 3 months, 6months
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Taiwanese version of the Pittsburgh Sleep Quality Index
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3 months, 6months
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Readmission rate Survival
Prazo: 1 year
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pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
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1 year
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- N201704032
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