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Shared Care for Patients With Type 2 Diabetes Across the Primary and Secondary Health Care Sector

2. januar 2019 opdateret af: Lene Munch, University Hospital, Gentofte, Copenhagen

The aim of the study is to test the effect of a new shared care model for type 2 diabetes care and compare it with a standardized care management program in a specialized hospital-based out-patient clinic.

The hypothesis is that participants with type 2 diabetes followed in a shared care program will have a comparable outcome in HbA1c to participants receiving standard care.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The prevalence of patients with type 2 diabetes is in growth globally. In order to secure high quality in diabetes care it is necessary to rethink the way in which the care is organized. The investigators want to test a new model of shared care across the interface of primary and secondary care sector for patients with type 2 diabetes who are at risk stratification level 2. Based on a national and regional risk stratification model patients can be stratified to three levels according to risk and complexity of treatment: level 1 (uncomplicated), level 2 (intermediate risk) and level 3 (high risk).

The objective of the study is to show equal outcomes among the participants being treated in either a shared care program or an established program in a specialized outpatient clinic.

The study is a non-inferiority randomized controlled trial. The shared care model will be tested during a period of three years. All participants are offered four medical visits a year. The shared care intervention consists of one annual comprehensive check-up at the outpatient clinic and three quarterly visits at a general practice. The control group is followed with four quarterly visits at the outpatient clinic including an annual comprehensive check-up. The recruitment period spans over approximately 12 months, and participants are randomized to intervention or control group in a 1:1 ratio.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Hellerup, Danmark, DK-2900
        • Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Must be over the age of 18 years
  • The diagnosis of type 2 diabetes
  • Risk stratification level 2
  • Capable of speaking and writing in Danish
  • Give oral and written consent before entering the study

Exclusion Criteria:

  • Diagnosed with other types of diabetes than type 2 diabetes
  • Risk stratification level 1 or 3
  • Being pregnant or breastfeeding
  • Having severe co-morbidity with life expectancy less than five years
  • Being under such conditions, that the patient will not be able to show up or go through with the appointments (e.g. moderate to severe dementia and severe psychiatric conditions)
  • Participating in long-lasting interventions (>2 weeks) that potentially affects the primary outcome in our study or patients participating in studies which include blood sampling amounting to >5 % of the blood volume two months prior to the randomisation and/or the follow-up visits

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Shared care model
Four visits a year: one annual comprehensive check-up at the outpatient diabetes clinic and three quarterly visits at the general practitioner.
Andet: Shared care
Ingen indgriben: Mono sectorial care
Treament as usual including four visits a year with the diabetes team at the outpatient clinic: an annual comprehensive check-up, identical to the one received by the intervention group, and three quarterly visits.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months
Tidsramme: Baseline and follow-up at 12, 24 and 36 months
Baseline and follow-up at 12, 24 and 36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The proportion of patients who meet national standard indicators reflecting quality of care
Tidsramme: Follow-up at 12, 24 and 36 months after baseline
These indicators cover seven areas: HbA1c, blood pressure, low density lipoprotein, albuminuria, fundoscopy, foot examination and smoking status.
Follow-up at 12, 24 and 36 months after baseline

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline Quality of life at 12, 24 and 36 months
Tidsramme: Baseline and follow-up at 12, 24 and 36 months
Measured by the Short Form 36 (SF-36)
Baseline and follow-up at 12, 24 and 36 months
Change from baseline blood pressure at 12, 24 and 36 months
Tidsramme: Baseline and follow-up at 12, 24 and 36 months
Baseline and follow-up at 12, 24 and 36 months
Change from baseline diabetes symptoms at 12, 24 and 36 months
Tidsramme: Baseline and follow-up at 12, 24 and 36 months
Meassured by the Diabetes Symptom Checklist-revised (DSC-r).
Baseline and follow-up at 12, 24 and 36 months

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Gentofte, Copenhagen

Samarbejdspartnere

Metropolitan University College

Efterforskere

  • Ledende efterforsker: Lene Munch, MHS, Ph.D.-student, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Denmark. Institute of Nursing, University College Metropol, Denmark.

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. august 2015

Primær færdiggørelse (Faktiske)

1. december 2018

Studieafslutning (Faktiske)

1. december 2018

Datoer for studieregistrering

Først indsendt

21. oktober 2015

Først indsendt, der opfyldte QC-kriterier

22. oktober 2015

Først opslået (Skøn)

26. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DIA-1234

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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