Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT) (INPUT)
24 de noviembre de 2017 actualizado por: Norbert Hermanns
Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy
This study is a randomized, controlled, prospective trial with a 6-month follow-up.
A newly developed treatment and education programme for diabetic patients with an insulin pump therapy (INPUT) will be tested compared to a waiting group.
Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up.
Secondary outcome variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia awareness, and attitudes towards insulin pump therapy.
Descripción general del estudio
Descripción detallada
INPUT is a self-management-based treatment and education program for diabetic patients with an insulin pump (CSII). It is designed to empower patients to adequately perform their therapy in daily life and to integrate their diabetes and their insulin pump into their lifes in order to enhance quality of life.
INPUT ist tested in an randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for CSII exists.
This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of INPUT will take place at the respective practice.
Baseline measurement will take place 2 weeks prior to the beginning of INPUT. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of INPUT, follow-up measurements will be conducted at the respective study center.
HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Secondary outcome measures will be assessed via psychometrically tested questionnaires, Case Reports Forms, or patient files.
Tipo de estudio
Intervencionista
Inscripción (Actual)
268
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
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Neuss, Alemania, 41462
- Diabetologische Schwerpunktpraxis Neuss
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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
16 años a 75 años (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Existing insulin pump therapy
- Prior participation in a structured diabetes education program
- HbA1c ≥ 7,5% but ≤ 13%
- Ability to understand, speak and write German language
- informed consent (if necessary, informed consent of the parents)
Exclusion Criteria:
- Diabetes duration < 1 year
- severe organic disease preventing a regular participation in the training course
- pregnancy
- severe cognitive impairment
- current treatment of psychiatric disorder
- renal disease requiring dialysis
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: INPUT
INPUT consists of 12 lessons comprising all relevant information in order to treat diabetes with an insulin pump.
Patients learn to effectively use the different features of their pump in order to improve not only glycemic control but also to improve the implementation of pump therapy in daily life.
Psychological and motivational aspects of living with diabetes and living with an insulin pump are addressed as well.
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Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.
Otros nombres:
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Sin intervención: Waiting list
Patients are randomly assigned to the waiting list.
After completion of the 6-month follow-up, these patients will also receive training with INPUT.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in Glycemic Control Measured by A1c
Periodo de tiempo: 6 months
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Difference between baseline A1c and A1c at the 6-month follow-up
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hypoglycaemia Awareness
Periodo de tiempo: 6 months
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The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness.
This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.
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6 months
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Diabetes Empowerment
Periodo de tiempo: 6 months
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Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
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6 months
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Problem Areas in Diabetes
Periodo de tiempo: 6 months
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The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
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6 months
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Satisfaction with current treatment
Periodo de tiempo: 6 months
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Satisfaction with current treatment is assessed via a 10-item scale.
The total score ranges from 10 to 60 with lower scores indicating higher satisfaction.
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6 months
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Diabetes Self-Management
Periodo de tiempo: 6 months
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The Diabetes Self-Management Questionnaire is a self-report measure of patients' self-care.
The level of self-care is assessed via Likert scales.
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6 months
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Diabetes Distress
Periodo de tiempo: 6 months
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The Diabetes Distress Scale (DDS) assesses diabetes-related stressors due to living and treating diabetes.
Different aspects of distress are covered: emotional burden, physician-related, regimen-related, diabetes-related interpersonal
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6 months
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Health-related Quality of Life
Periodo de tiempo: 6 months
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Health-related quality of life focuses on the health-specific aspects of quality of life and dealing with a chronic condition such as diabetes
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6 months
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Depressive symptoms
Periodo de tiempo: 6 months
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The presence and extent of typical depressive symptoms are assessed via self-report
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6 months
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Attitudes towards insulin pump therapy
Periodo de tiempo: 6 months
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Specific attitudes towards different aspects of insulin pump therapy are assessed via Likert scales.
The questionnaire consists of 6 subscales that can be placed within 4 dimensions: (I) Expectations on insulin pump therapy (subscale: achieving better glycaemic control) (II) Perceived advantages of an insulin pump (subscale: gaining more flexibility) (III) Ease of use (subscales: design + functionality) (IV) Psychosocial effects and barriers (subscales: technological dependence + impaired body image)
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6 months
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Severe hypoglycaemia
Periodo de tiempo: 6 months
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The incidence of severe hypoglycaemia in the past six months is assessed via Case Report Forms.
Severe hypoglycaemia is defined as requiring third party assistance or medical intervention for treating hypoglycaemia.
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6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
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.
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 abril de 2016
Finalización primaria (Actual)
1 de febrero de 2017
Finalización del estudio (Actual)
1 de marzo de 2017
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
11 de agosto de 2016
Publicado por primera vez (Estimar)
16 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de noviembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
24 de noviembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NH012016
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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