- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Winsome Lam, PhD
- Numer telefonu: 4291 852-2766
- E-mail: winsome.lam@polyu.edu.hk
Lokalizacje studiów
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Hong Kong, Chiny, 852
- School of Nursing The Hong Kong Polytechnic University
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Kontakt:
- winsome Yorke, PhD
- Numer telefonu: 4291 852-2766
- E-mail: winsome.lam@polyu.edu.hk
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Caregiving Self-efficacy
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Modified Memorial Symptom Assessment Scale
Ramy czasowe: 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).
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Time Frame: Day 0, Month 3, Month 6
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Children health service utilization
Ramy czasowe: 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.
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Time Frame: Day 0, Month 3, Month 6
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Depression Anxiety Stress Scale (DASS) (Chinese version)
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- DonationHongKongPolyU
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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