- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03951168
Health Education for Diabetes Mellitus (hefdm)
Study on Standardized Management Model of Health Education for Diabetes Mellitus
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim was to develop a standardized patient education model reflecting the core educational elements recommended by Chinese diabetes society guideline, which could be delivered by nurses to hospitalized diabetes patients, and which could be easily scaled-up and implemented in China tier 3 hospital setting.
Management mode of standardized diabetes mellitus health education in intervention group.The control group carries on the routine diabetes mellitus health education management. In intervention group , All participants received Management mode of standardized diabetes mellitus health education.The standardized patient education included one-week personalized education on diabetes knowledge, diet and excise, glucose monitoring and hypoglycemia self-management and others during the hospitalization period. After discharge, patients were followed through the phone call at 2and 4 weeks. Follow-up of diabetic education outpatients at 12 and 24 weeks after discharge. The education nurse gave recommendations according to patent's problem during the follow-up. Full-time education nurses carry on education according to diabetes mellitus health education path table. In routine, After hospitalization, the responsible nurses interspersed with diabetes health education during the hospitalization. The health education is mainly about the problems observed by the responsible nurses and the problems raised by the patients. The patients were followed up by telephone 2 weeks after discharge.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710061
- First Affiliated Hospital of Xi'an JiaoTong University
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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:
- Type 2 diabetes patients with World Health Organization(WHO) diagnosis (1999);
- HbA1c ≥ 7.5%;
- history of diabetes < 2 years;
- age from 18 to 70 years;
- having the ability of autonomous behavior, informed consent and voluntary participation in the study.
Exclusion Criteria:
- type 1 diabetes mellitus, gestational diabetes mellitus and other special types of diabetes;
- severe acute and chronic diseases, severe psychological failure, lung failure, tumor, etc.
- is participating in other researchers.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Routine Management
The patients were divided into routine diabetic health education management model group.
Patients who meet the criteria for admission and discharge.
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Routine Management Model of Health Education for diabetes Patient will receive the Routine Management Model of Health Education for Diabetes.
After the patient was admitted to hospital, the responsible nurse carried on the diabetes health education for the patient.
There are no regulations on the path and time of education.
Interspersed with diabetes health education at work.
Follow up 2 weeks with phone call after discharge.
This is the current clinical model in hospital.
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Experimental: Standardized Management
The patients were divided into standardized diabetes health education management model group.
Patients who meet the criteria for admission and discharge.
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Standardized Management Model of Health Education for Diabetes The patients were educated by full-time diabetic education nurses according to diabetes education path.
Including diabetes diet, exercise, drugs, hypoglycemia, diabetic foot, and so on.
Telephone follow-up was performed at 2 weeks and 4 weeks after discharge and 12 and 24 weeks follow-up in diabetes education clinic.
Develop telephone follow-up standardized content and implement telephone follow-up according to standardized content.Full-time education nurses carry on education according to diabetes mellitus health education path table.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Diabetes knowledge questionnaire ( DKQ)
Periodo de tiempo: after 6 months
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The DKQ was translated from English into Chinese by a native bilingual translation specialist and then back translated by a different native bilingual speaker and checked for accuracy, clarity and content equivalence by conducting forward and back translations to verify translation equivalence. DKQ was translated from English into Chinese by a native bilingual translation specialist and then back translated by a different native bilingual speaker and checked for accuracy,clarity and content equivalence by conducting forward and back translations to verify translation equivalence. |
after 6 months
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Summary of Diabetes Self-Care Activities-6 (SDSCA-6)
Periodo de tiempo: after 6 months
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Evaluation the patient self management skill
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after 6 months
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Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF)
Periodo de tiempo: after 6 months
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Evaluation the patient empowerment
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after 6 months
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Diabetes Specific Quality of Life
Periodo de tiempo: after 6 months
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Evaluation the patient quality of life
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after 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HbA1c
Periodo de tiempo: after 6 months
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the patient'S blood glucose level
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after 6 months
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Fasting glucose
Periodo de tiempo: after 6 months
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the patient'S blood glucose level
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after 6 months
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2h postprandial glucose
Periodo de tiempo: after 6 months
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the patient'S blood glucose level
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after 6 months
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blood pressure
Periodo de tiempo: after 6 months
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the patient 'S blood pressure
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after 6 months
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Total Cholesterol
Periodo de tiempo: after 6 months
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the patient'S Total Cholesterol
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after 6 months
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LDL-C
Periodo de tiempo: after 6 months
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he patient'S LDL-C
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after 6 months
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HDL-C
Periodo de tiempo: after 6 months
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he patient'S HDL-C
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after 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Meng Li, First Affiliated Hospital of Xi'an JiaoTong Univerisity
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018KRM115
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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