- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Winsome Lam, PhD
- Número de teléfono: 4291 852-2766
- Correo electrónico: winsome.lam@polyu.edu.hk
Ubicaciones de estudio
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Hong Kong, Porcelana, 852
- School of Nursing The Hong Kong Polytechnic University
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Contacto:
- winsome Yorke, PhD
- Número de teléfono: 4291 852-2766
- Correo electrónico: winsome.lam@polyu.edu.hk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿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 |
|---|---|
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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Caregiving Self-efficacy
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Modified Memorial Symptom Assessment Scale
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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
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Palabras clave
Otros números de identificación del estudio
- DonationHongKongPolyU
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Información sobre medicamentos y dispositivos, documentos del estudio
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