- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07762157
The Effectiveness of Tele-pulmonary Rehabilitation Program on People With Chronic Obstructive Pulmonary Disease (COPD) After Hospitalization for Acute Exacerbation
Introduction: There are great impacts of chronic obstructive pulmonary disease (COPD) over healthcare and economic systems globally. Managing COPD stably in community is still a challenging topic due to its progressive nature, it is valuable to be studied with a view to improving the health status and quality of life in people with COPD and thus relieving the healthcare and economic burdens. Pulmonary rehabilitation (PR) was proven to be cost-effective with clinical benefits in optimizing quality of life, physical conditions and reducing hospital re-admissions rate in people with COPD. Traditionally, PR training was conducted under professional supervision in a face-to-face format. Community-based PR, like tele-rehabilitation, centre-based and homebased rehabilitation are emerging as an effective alternative to traditional PR. Promoting community-based rehabilitation is possibly one of the ways to engage people with chronic diseases in selfmanagement at their doorstep, which will help to tackle the escalating aging population and their heavy burden to the public healthcare system in Hong Kong.
Objectives: The objectives of this study are:
- To evaluate the clinical effectiveness of the newly developed tele-pulmonary rehabilitation program on people with COPD after hospitalized acute exacerbation,
- To explore participants' experience towards the program and develop a deeper understanding about the enablers and barriers faced by participants in joining the - tele-pulmonary rehabilitation program for quality assessment and improvement Methodology: Quasi-experimental design will be adopted in quantitative study, participants will join an eight-session tele-PR program in the intervention group, and participants will join the control group when pending for traditional out-patient based PR program. Purposive sampling will be adopted, participants should be clinically diagnosed COPD, able to participate in scheduled PR program and able to listen, speak, read and understand Chinese. Four domains of outcome measures will be collected, including participant profile, physical health status, health-related quality of life and healthcare resources utilization, for evaluation. Qualitative study with phenomenological approach will be adopted to discover participants' experience in the service. Semistructured, individual face-to-face in-depth interviews will be conducted once participants complete the tele-pulmonary rehabilitation program. Significance: This study will provide solid evidence on the effectiveness of tele-pulmonary rehabilitation program for people with COPD after hospitalized for acute exacerbation.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Kim Chung Mo
- Номер телефона: 852 26837822
- Электронная почта: Dennis.Mo@link.cuhk.edu.hk
Места учебы
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Hong Kong, Гонконг
- Рекрутинг
- North District Hospital
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Контакт:
- Kim Chung Mo
- Номер телефона: 852 26837822
- Электронная почта: Dennis.Mo@link.cuhk.edu.hk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Clinically diagnosed chronic obstructive pulmonary disease (therefore, with or without confirmation by previous spirometry), no limitation on GOLD stage for participants with previous spirometry; AND
- Aged 18 or above, without limitation on sex, smoking history and medications using; AND
- Able to participate in the scheduled pulmonary rehabilitation program; AND
- Owning private electronic devices and Internet connection at
Exclusion Criteria:
- With unstable medical conditions; OR
- With major musculo-skeletal, neurological, psychiatric or cognitive disorders; OR
- Refusal on clinical study.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: Контроль
Обычный уход
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Экспериментальный: Intervention
Tele-pulmonary rehabilitation
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All exercises content will follow classic pulmonary rehabilitation, but will be conducted in tele-health format
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Six Minute Walk Test (6MWT)
Временное ограничение: Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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The Six Minute Walk Test (6MWT) uses a standard 30-meter indoor hallway protocol (measurement tool) to evaluate functional exercise capacity.
The unit of measure is the total distance walked in meters.
Scores range from a theoretical minimum of 0 meters to an unlimited maximum based on functional ability; higher values represent a better outcome (greater exercise tolerance).
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Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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Saint George's Respiratory Questionnaire (Hong Kong Chinese version) (SGRQ-HK)
Временное ограничение: Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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The Saint George's Respiratory Questionnaire (Hong Kong Chinese version) (SGRQ-HK) is a disease-specific questionnaire (measurement tool) used to assess health-related quality of life.
The unit of measure is the SGRQ total score (expressed as a points from 0 to 100).
Scores range from a minimum of 0 to a maximum of 100; higher values mean a worse outcome (greater health impairment and lower quality of life).
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Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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Unplanned hospital re-admission rate
Временное ограничение: Measure twice at 28-day and 3-month post-hospital discharge, independent to the intervention time-frame
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The Unplanned Hospital Re-admission Rate uses electronic medical record audit logs to evaluate health resource utilization.
It is a binary variable that 'Yes' or 'No' are the only options.
Unplanned is referring to any unscheduled admissions via Emergency Department, the time frame was within 28 days and within 3 months of the last hospital discharge, the date of the latest hospital discharge is defined as day 0.
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Measure twice at 28-day and 3-month post-hospital discharge, independent to the intervention time-frame
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Modified Medical Research Council (mMRC) dyspnea scale
Временное ограничение: Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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The Modified Medical Research Council (mMRC) dyspnea scale is a self-reported categorical rating scale (measurement tool) assessing the severity of breathlessness during daily activities.
The unit of measure is the mMRC grade 0 to 4. Scores range from a minimum grade of 0 (breathless only with strenuous exercise) to a maximum grade of 4 (too breathless to leave the house or breathless when dressing); higher grades mean a worse outcome.
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Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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Dyspnoea-12 (Chinese version) (D-12-C)
Временное ограничение: Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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The Dyspnoea-12 (Chinese version) (D-12-C) is a 12-item assessing both physical and affective components of breathlessness.
The unit of measure is the D-12-C total score (summed points).
Scores range from a minimum of 0 to a maximum of 36; higher scores mean a worse outcome (more severe dyspnea symptoms).
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Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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Five-Time-Sit-To-Stand test (FTSTS)
Временное ограничение: Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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The Five-Time Sit-to-Stand test (FTSTS) utilizes a standardized 43-cm chair and stopwatch protocol (measurement tool) to evaluate lower-limb muscle power and functional mobility.
The unit of measure is the time taken to complete 5 repetitions, in seconds.
Scores range from a lower practical bound of 0 seconds (a maximum cutoff of 60 seconds is applied for non-completion); higher times in seconds mean a worse outcome (slower performance and reduced mobility).
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Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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Handgrip strength
Временное ограничение: Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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Handgrip Strength is measured using a standardized hydraulic hand dynamometer (JAMAR® Model J00105, Lafayette Instrument Company, United States of America) to assess upper-limb isometric muscle strength.
The unit of measure is kilograms of force (kg).
Scores range from a minimum of 0 kg to an upper physiological limit; higher values represent a better outcome (greater muscle strength).
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Baseline measure within 3 days the participants are discharged from in-patient care; AND post-intervention measure at 8-week after baseline measure
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2025.524
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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