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Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT) (INPUT)

24. november 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

268

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Neuss, Tyskland, 41462
        • Diabetologische Schwerpunktpraxis Neuss

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: INPUT

Treatment and education program based on the self-management theory of behavioral medicine.

The program is delivered by certified and specially trained diabetes educators.

Andre navne:
  • treatment and education program for INsulin PUmp Therapy
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Glycemic Control Measured by A1c
Tidsramme: 6 months
Difference between baseline A1c and A1c at the 6-month follow-up
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hypoglycaemia Awareness
Tidsramme: 6 months
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.
6 months
Diabetes Empowerment
Tidsramme: 6 months
Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
6 months
Problem Areas in Diabetes
Tidsramme: 6 months
The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
6 months
Satisfaction with current treatment
Tidsramme: 6 months
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.
6 months
Diabetes Self-Management
Tidsramme: 6 months
The Diabetes Self-Management Questionnaire is a self-report measure of patients' self-care. The level of self-care is assessed via Likert scales.
6 months
Diabetes Distress
Tidsramme: 6 months
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
6 months
Health-related Quality of Life
Tidsramme: 6 months
Health-related quality of life focuses on the health-specific aspects of quality of life and dealing with a chronic condition such as diabetes
6 months
Depressive symptoms
Tidsramme: 6 months
The presence and extent of typical depressive symptoms are assessed via self-report
6 months
Attitudes towards insulin pump therapy
Tidsramme: 6 months
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)
6 months
Severe hypoglycaemia
Tidsramme: 6 months
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.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norbert Hermanns

Samarbejdspartnere

Berlin-Chemie

Efterforskere

  • Ledende efterforsker: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2016

Primær færdiggørelse (Faktiske)

1. februar 2017

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

20. april 2016

Først indsendt, der opfyldte QC-kriterier

11. august 2016

Først opslået (Skøn)

16. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NH012016

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Diabetes mellitus

Kliniske forsøg med INPUT

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Betingelser

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