- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01154725
The Effect of Patient Education and Rehabilitation on Quality of Life in Patients With Permanent Stomas
Effect of Patient Education and Rehabilitational Interventions on Health Related Quality of Life of Patients With Permanent Stomas Regardless of Cause
The purpose of the experiment is to study the effect it has on patients' quality of life if they go through a structured process marked by intensified and specialized effort by ostomy nurse. This includes close monitoring during hospitalization, telephone contact and guidance following discharge and participation in a group based patient school up to 4 months after discharge .
At the same time the study also examines what the economic effect of following the intervention will have.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Construction of an ostomy is a radical treatment with permanent physical signs of body alteration. It leads to loss of a central and very personal bodily function (excretion of faeces through the rectum) and there is a significant change in personal hygiene.
Having a colostomy is not a uniform state but is characterized by many different factors: Several types of ostomy, several underlying causes that lead to stoma creation such as cancer, several individual psychosocial profile, which naturally affect individuals differently. Patients are forced to living with a changed body image, a change in daily routines, and for some there will also be changes in lifestyle, social standing and their sexuality will be affected. At the same time patients experience a break when they are discharged from the hospital, and they may lack the practical and emotional support.
The training and education of patients is increasingly being carried out by stoma nurses both in Denmark and internationally. The primary role is to inform and prepare patients before surgery and to keep the contact with patients after surgery to ensure the fulfillment of the patient´s independent and meaningful life after ostomy construction. It is assumed that ostomy nurse's intervention and involvement are important for the patient's quality of life, but there are no studies that uniquely identifies the type of education that has the greatest effect, which applies both to content and methods.
Quality of life measurement in health care is a merging method to ensure the patient´s perspective on health treatments.It is greatly needed to test the efficacy of nursing interventions on patients' quality of life. Pressure on health services increase which makes it imperative also to include analysis and calculation of economic effect of the intervention.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Herlev, Dinamarca, 2730
- Herlev University Hospital
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Herlev, Dinamarca, 2730
- Department of Surgery, Herlev University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- All patients with permanent or temporary stomas regardless of cause that are expected to be able to cooperate in filling out questionnaires and who will participate in the planned interventions.
Exclusion criteria:
- Patients that post-operatively are not able to cooperate and participate in the planned interventions.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Habitual stoma care
habitual patient education
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habitual patient education
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Experimental: Patient education and rehabilitation
patient education and rehabilitation
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Patients in the experimental group will receive specialized and optimized care by stoma care nurses.
This includes one-on-one guiding during the hospitalization, guidance by telephone after discharge and participation in patient education 3 times after discharge.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Ostomy Adjustment Scale measurement of quality of life
Periodo de tiempo: 6 months (+/- 2 weeks) postoperatively
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the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
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6 months (+/- 2 weeks) postoperatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Economic effect
Periodo de tiempo: 6 months after discharge
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The investigators will monitor readmittance and contacts and diagnostic procedures and therapeutic interventions related to stoma creation during the period from admittance to hospital until 6 months after discharge.
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6 months after discharge
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Ostomy Adjustment Scale and SF-36 measurement of quality of life
Periodo de tiempo: 3 months (+/-2 weeks) postoperatively
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the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
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3 months (+/-2 weeks) postoperatively
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Ostomy Adjustment Scale and SF-36 measurement of quality of life
Periodo de tiempo: 3-7 days postoperatively before discharge
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the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
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3-7 days postoperatively before discharge
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SF-36 measurement of quality of life
Periodo de tiempo: 6 months (+/- 2 weeks) postoperatively
|
the study measures quality of life both with the disease specific questionnaire Ostomy Adjustment Scale and also with a generic questionnaire Sf-36.
|
6 months (+/- 2 weeks) postoperatively
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anne K Danielsen, Nurse, MaClN, Herlev University Hospital, Department of Gastroenterology
Publicaciones y enlaces útiles
Publicaciones Generales
- Danielsen AK, Rosenberg J. Patient education after stoma creation may reduce health-care costs. Dan Med J. 2014 Apr;61(4):A4659.
- Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- AKD01
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