Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT) (INPUT)
Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Neuss, Niemcy, 41462
- Diabetologische Schwerpunktpraxis Neuss
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
Inne nazwy:
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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Changes in Glycemic Control Measured by A1c
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Hypoglycaemia Awareness
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NH012016
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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