- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07652268
Nurse-led Integrated Home Service to Support Parents in Symptom Management for Children Requiring Respiratory Support
Nurse-led Integrated Home Health Service to Support Parents in Symptom Management for Children With Respiratory Support: an Effectiveness-implementation Hybrid 2 Study
The aims of this study are to test the effectiveness of a nurse-led integrated home health service to enhance parental self-efficacy in symptom management for children requiring respiratory support, and alongside identify factors facilitating or deterring the program implementation.
A single group pre-post quasi-experimental study on parents of CMC requiring respiratory support.
Parents will be recruited from non-government organizations, with an estimated sample size of 80 parents. Self-administrated questionnaire, and semi-structured interview guide will be used for data collection.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Parents of children required respiratory support are at risk of high stress levels because these children have multisystem diseases, including severe neurologic conditions, resulting in potential premature death. Literature suggested that increasing parental self-efficacy in managing their child's symptoms could improve the child's health.
Nurse-led integrated home health service in symptom management is an alternative method considered more comprehensive and health-parent interactivity to continue home-based support for these parents and their children.
Self-administrated questionnaire, and semi-structured interview guide will be used for data collection. Descriptive statistics, including proportions for categorical variables, mean, and SD for normally distributed continuous variables, and median and inter-quartile range for non-normally distributed variables, will be reported. Generalized estimating equation will be used to address the objectives with appropriate link function. Qualitative data will be analyzed using thematic analysis to identify the facilitator, and barriers of program implementation.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Winsome Lam, PhD
- Номер телефона: 4291 852-2766
- Электронная почта: winsome.lam@polyu.edu.hk
Места учебы
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Hong Kong, Китай, 852
- School of Nursing The Hong Kong Polytechnic University
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Контакт:
- winsome Yorke, PhD
- Номер телефона: 4291 852-2766
- Электронная почта: winsome.lam@polyu.edu.hk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- parent of a child with respiratory support aged 6-month to 22 years old
- having a Smartphone
- able to communicate in Chinese or in English
- living with his/her child at home.
Exclusion Criteria:
- a reported mental health disorder
- engaging in other structured programs related to symptom management
- living in an area with no internet coverage
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Nurse-led integrated home service
Nurse-led integrated home service to support parents in Symptom Management for Children With Respiratory Support for a 3-month period.
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Nurse-led integrated home service to support parents in Symptom Management for Children With Respiratory Support for a 3-month period.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Caregiving Self-efficacy
Временное ограничение: Time Frame: Day 0, Month 3, Month 6
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The scale consists of 18 items to measure the self-efficacy of Chinese caregivers.
It is rated on a 9-point scale, with 1= no confidence, to 9 =full confidence.
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Time Frame: Day 0, Month 3, Month 6
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Implementation evaluation
Временное ограничение: Time Frame: month 6
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Semi-structured interviews will be conducted to the related community stakeholders to evaluate the quality of service provided. Semi-structured interview guide will be used to collect qualitative data in four perspectives including:
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Time Frame: month 6
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Depression Anxiety Stress Scale (DASS) (Chinese version)
Временное ограничение: Time Frame: Day 0, Month 3, Month 6
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DASS is a self-report instrument consisting of 21 items used to assess the states of depression, anxiety and stress in parents.
It is rated on a 4-point scale from 0 (does not apply to me at all) to 3 (applies to me very much, or most of the time).
A higher score on each subscale indicates more severe symptoms of depression, anxiety and stress.
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Time Frame: Day 0, Month 3, Month 6
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Modified Memorial Symptom Assessment Scale
Временное ограничение: Time Frame: Day 0, Month 3, Month 6
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This is a modified 40-item Memorial Symptom Assessment Scale (MSAS in Chinese version).
The items for measuring the frequency and severity of symptoms are rated on a 4-point Likert scale from one (almost never) to four (always).
The items for measuring distress are rated on a 5-point Likert scale from one (not at all) to five (very).
A higher score on each subscale indicates the child is experiencing more symptom burden.
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Time Frame: Day 0, Month 3, Month 6
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Children health service utilization
Временное ограничение: Time Frame: Day 0, Month 3, Month 6
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This is a record used to summarize a child's visits to outpatient clinic and emergency room, and the child's admission history.
Higher non-scheduled health visit rates mean the child's health condition worsen
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Time Frame: Day 0, Month 3, Month 6
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- 1. Cohen, E., et al., Children with medical complexity: an emerging population for clinical and research initiatives. Pediatrics, 2011. 127(3): p. 529-538. 2. Chan, K.S., Palliative care: the need of the modern era. Hong Kong Med J, 2018. 24(4): p. 391-399. 3. Chung, W.W., et al., Improving Children's cancer pain management in the home setting: Development and formative evaluation of a web-based program for parents. Comput Biol Med, 2018. 101: p. 146-152. 4. Kun SS, Davidson-Ward SL, Hulse LM, Keens TG. How much do primary care givers know about tracheostomy and home ventilator emergency care? Pediatr Pulmonol. 2010 Mar;45(3):270-4. doi: 10.1002/ppul.21169. PMID: 20146395. 5. Truitt BA, Ghosh RN, Price EW, Du C, Bai S, Greene D, Simon DM, Reeder W, Kasi AS. Family Caregiver Knowledge in the Outpatient Management of Pediatric Tracheostomy-Related Emergencies. Clin Pediatr (Phila). 2025 Jul;64(7):936-943. doi: 10.1177/00099228241304480. Epub 2024 Dec 20. PMID: 39707594. 6. Wang, J., et al., Supporting Caregivers of Children With Acute Lymphoblastic Leukemia via a Smartphone App: A Pilot Study of Usability and Effectiveness. Comput Inform Nurs, 2016. 34(11): p. 520-527. 7. Bandura, A., Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev, 1977. 84(2): p. 191-215. 8. Kwok and Wong, Mental health of parents with young children in Hong Kong: The roles of parenting stress and parenting self-efficacy. Child & Family Social Work, 2000. 5(1): p. 57-65. 9. Streisand, R., et al., Pediatric parenting stress among parents of children with type 1 diabetes: the role of self-efficacy, responsibility, and fear. J Pediatr Psychol, 2005. 30(6): p. 513-21. 10. World Health Organization mHealth: new horizons for health through mobile technologies 2011. 11. Crable, E.L., et al., Standardizing an approach to the evaluation of implementation science proposals. Implement Sci, 2018. 13(1): p. 71. 12. Curran, G.M., et al., Effectiveness-implementation hybrid designs: combi
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
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
Ключевые слова
Другие идентификационные номера исследования
- DonationHongKongPolyU
Планирование данных отдельных участников (IPD)
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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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