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Nurse-led Integrated Home Service to Support Parents in Symptom Management for Children Requiring Respiratory Support

11 de junio de 2026 actualizado por: Dr Winsome Lam

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Hong Kong, Porcelana, 852
        • School of Nursing The Hong Kong Polytechnic University
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. parent of a child with respiratory support aged 6-month to 22 years old
  2. having a Smartphone
  3. able to communicate in Chinese or in English
  4. living with his/her child at home.

Exclusion Criteria:

  1. a reported mental health disorder
  2. engaging in other structured programs related to symptom management
  3. living in an area with no internet coverage

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Nurse-led integrated home service to support parents in Symptom Management for Children With Respiratory Support for a 3-month period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Caregiving Self-efficacy
Periodo de tiempo: Time Frame: Day 0, Month 3, Month 6
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.
Time Frame: Day 0, Month 3, Month 6
Implementation evaluation
Periodo de tiempo: Time Frame: month 6

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:

  1. reach: document the number of participants, and retention in the intervention
  2. adoption: seek to find out if the intervention is appropriate and in action
  3. implementation: understand stakeholders' perception if the intervention is acceptable and implemented as planned
  4. maintenance: explore the facilitators and barriers in the sustainability of the nurse-led integrated home service
Time Frame: month 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Modified Memorial Symptom Assessment Scale
Periodo de tiempo: Time Frame: Day 0, Month 3, Month 6
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).
Time Frame: Day 0, Month 3, Month 6
Children health service utilization
Periodo de tiempo: Time Frame: Day 0, Month 3, Month 6
This is a record used to summarize a child's visits to outpatient clinic and emergency room, and the child's admission history.
Time Frame: Day 0, Month 3, Month 6
Depression Anxiety Stress Scale (DASS) (Chinese version)
Periodo de tiempo: Time Frame: Day 0, Month 3, Month 6
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.
Time Frame: Day 0, Month 3, Month 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • 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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

30 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • DonationHongKongPolyU

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Privacy

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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