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Health Education for Diabetes Mellitus (hefdm)

17 de noviembre de 2020 actualizado por: First Affiliated Hospital Xi'an Jiaotong University

Study on Standardized Management Model of Health Education for Diabetes Mellitus

Through the construction and study of standardized diabetic health education management model. Routine diabetes health education management model was used in control group and standardized diabetes mellitus health education management model was used in intervention group. The changes of diabetic knowledge, self-management ability, quality of life,patient empowerment, HbA1c, and other metabolic indexes were observed.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

206

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.

Ubicaciones de estudio

    • Shaanxi
      • Xi'an, Shaanxi, Porcelana, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University

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

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

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: 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.
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.
Experimental: Standardized Management
The patients were divided into standardized diabetes health education management model group. Patients who meet the criteria for admission and discharge.
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.

¿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

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
Summary of Diabetes Self-Care Activities-6 (SDSCA-6)
Periodo de tiempo: after 6 months
Evaluation the patient self management skill
after 6 months
Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF)
Periodo de tiempo: after 6 months
Evaluation the patient empowerment
after 6 months
Diabetes Specific Quality of Life
Periodo de tiempo: after 6 months
Evaluation the patient quality of life
after 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HbA1c
Periodo de tiempo: after 6 months
the patient'S blood glucose level
after 6 months
Fasting glucose
Periodo de tiempo: after 6 months
the patient'S blood glucose level
after 6 months
2h postprandial glucose
Periodo de tiempo: after 6 months
the patient'S blood glucose level
after 6 months
blood pressure
Periodo de tiempo: after 6 months
the patient 'S blood pressure
after 6 months
Total Cholesterol
Periodo de tiempo: after 6 months
the patient'S Total Cholesterol
after 6 months
LDL-C
Periodo de tiempo: after 6 months
he patient'S LDL-C
after 6 months
HDL-C
Periodo de tiempo: after 6 months
he patient'S HDL-C
after 6 months

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Meng Li, First Affiliated Hospital of Xi'an JiaoTong Univerisity

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 (Actual)

1 de julio de 2019

Finalización primaria (Actual)

30 de junio de 2020

Finalización del estudio (Actual)

30 de junio de 2020

Fechas de registro del estudio

Enviado por primera vez

4 de mayo de 2019

Primero enviado que cumplió con los criterios de control de calidad

13 de mayo de 2019

Publicado por primera vez (Actual)

15 de mayo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de noviembre de 2020

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

17 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2018KRM115

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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

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. .

Ensayos clínicos sobre Diabetes mellitus

Ensayos clínicos sobre Routine Management

3
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