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Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

25. august 2016 opdateret af: Jaeb Center for Health Research
The purpose of this study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Although each patient with diabetes should be receiving diabetic education as part of their on-going routine medical care, it is likely that such education is delivered with different details and intensity. Motivating a patient with diabetes to become involved in his or her care is of primary importance in achieving better systemic control.

Ocular complications from diabetes remain the most common cause of blindness among American adults 20-74 years of age. A recent survey reported that loss of vision is the most feared of all diabetic complications. Thus, it is possible that an educational intervention at an ophthalmology office may have additional impact beyond the current standard of diabetes education at a primary care or diabetologist/endocrinologist office alone. This study will determine whether diabetes education in the ophthalmology office (which includes same-visit feedback of HbA1c levels, combined with standardized education regarding same-visit blood pressure, retinopathy status and overall diabetes education) can improve subsequent HbA1c as compared with current standard care in an ophthalmology office.

Materials used in this research setting must be applicable for use in ophthalmology practices. Therefore, the materials and procedures for this study have been developed with the goal of easy translation to this audience.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1875

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Health Care, Dept. of Ophthalmology
      • Santa Barbara, California, Forenede Stater, 93103
        • California Retina Consultants
    • Florida
      • Ft. Lauderdale, Florida, Forenede Stater, 33334
        • Retina Vitreous Consultants
      • Jacksonville, Florida, Forenede Stater, 32209
        • University of Florida College of Med., Department of Ophthalmology
      • Lakeland, Florida, Forenede Stater, 33805
        • Central Florida Retina Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46280
        • Raj K. Maturi, M.D., P.C.
      • New Albany, Indiana, Forenede Stater, 47150
        • John-Kenyon American Eye Institute
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509-1802
        • Retina and Vitreous Associates of Kentucky
      • Paducah, Kentucky, Forenede Stater, 42001
        • Paducah Retinal Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21237
        • Elman Retina Group, P.A.
      • Baltimore, Maryland, Forenede Stater, 21287-9277
        • Wilmer Ophthalmological Institute at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Joslin Diabetes Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Retina Center, PA
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • Barnes Retina Institute
    • New York
      • New York, New York, Forenede Stater, 10003
        • The New York Eye and Ear Infirmary/Faculty Eye Practice
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7040
        • University of North Carolina, Dept of Ophthalmology
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Charlotte Eye, Ear, Nose and Throat Assoc., PA
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Eye Center
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • Retina Associates of Cleveland, Inc.
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Casey Eye Institute
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State College of Medicine
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania Scheie Eye Institute
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29223
        • Carolina Retina Center
      • Columbia, South Carolina, Forenede Stater, 29169
        • Palmetto Retina Center
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Retina Research Center
      • Houston, Texas, Forenede Stater, 77025
        • Retina and Vitreous of Texas
      • McAllen, Texas, Forenede Stater, 78503
        • Valley Retina Institute
      • San Antonio, Texas, Forenede Stater, 78240
        • Retinal Consultants of San Antonio
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53705
        • University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin

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:

  1. Age >18 years

  2. Diagnosis of type 1 or type 2 diabetes mellitus

    Any one of the following will be considered to be sufficient evidence that diabetes is present:

    • Current regular use of insulin for the treatment of diabetes
    • Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
    • Documented diabetes by American Diabetes Associate and/or World Health Organization criteria
  3. Routine care follow-up is yearly or more frequent
  4. English or Spanish speaking
  5. Able and willing to provide informed consent
  6. Willing to complete 24 months of study follow up

Exclusion Criteria:

  1. Known HbA1c (patient report or available records at time of enrollment) <7.5% within prior 6 months
  2. Active participation in any type of intervention study
  3. Initiation of insulin treatment within 3 months from date of enrollment
  4. Prior complete panretinal photocoagulation or prior diabetes-related vitrectomy in both eyes
  5. Advanced visual acuity loss in both eyes which prohibits ability to read study materials (tested as needed with reading test using materials in appropriate size script)
  6. Significant renal disease including use of erythropoietin (Procrit, Epogen, Eprex) or a history of chronic renal failure requiring dialysis or kidney transplant

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standardpleje
Sædvanlig pleje
Eksperimentel: Diabetes Educational Intervention
Study participants in the intervention group will receive a diabetes management educational intervention at baseline and at follow-up visits. For those on an annual follow-up schedule, educational intervention will take place at baseline and 12 months. For those whose standard care involves more frequent, than annual, visits the educational intervention will take place no more than once every 12 weeks.
Adfærdsmæssigt: Diabetes Education

The intervention will consist of the following at enrollment and at each follow-up visit (but no more frequently than once every 12 weeks):

  • Measurement of HbA1c in office with immediate feedback
  • Measurement of blood pressure with immediate feedback
  • Assessment of retinopathy risk with immediate feedback
  • Personalized risk assessment reports based on current HbA1c
  • Brief assessment of patient understanding of key issues with immediate feedback
  • Supplemental diabetes management educational materials (provided at baseline only)
  • Feedback to primary care provider
  • Email reminder to study participants with email access of individualized risk assessment findings

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c
Tidsramme: 12 Months
Mean change in HbA1c from baseline to 12 months in intervention versus control for study participants being seen for standard care more frequently than every 12 months
12 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diabetes Care Knowledge
Tidsramme: 12 Months/24 Months
At baseline and at annual visits, study participants in all treatment groups will complete self-assessment questionnaires in order to assess perception of emotional problems frequently reported in type 1 and type 2 diabetes and to measure perceived adherence to diabetes self-care recommendations. At the annual visits, summary statistics will be presented on the responses as appropriate to the distribution and the treatment groups will be compared controlling for baseline responses.
12 Months/24 Months
Blood Pressure
Tidsramme: 12 Months/24 Months
For analyses, systolic and diastolic blood pressure will be converted to an overall mean blood pressure according to the following calculation: diastolic blood pressure + 1/3 (systolic blood pressure - diastolic blood pressure). Blood pressure will be analyzed as the change in the weighted mean blood pressure from baseline to 12 months adjusted for the baseline weighted mean blood pressure. Treatment group comparisons will be made using ANCOVA to adjust for the baseline blood pressure, with GEE to adjust for the correlation within subjects of the same cluster.
12 Months/24 Months
Body Mass Index
Tidsramme: 12 Months/24 Months
Treatment group comparisons will be made using analysis of covariance (ANCOVA) to adjust for the baseline HbA1c, with generalized estimating equations (GEE) to adjust for the correlation within subjects of the same randomization cluster.
12 Months/24 Months

Samarbejdspartnere og efterforskere

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

Sponsor

Jaeb Center for Health Research

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Eye Institute (NEI)

Efterforskere

  • Studiestol: Lloyd P Aiello, M.D., Joslin Diabetes Center

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

Hjælpsomme links

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

1. oktober 2011

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

24. marts 2011

Først indsendt, der opfyldte QC-kriterier

24. marts 2011

Først opslået (Skøn)

25. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DRCR.net-Protocol M

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 .

Kliniske forsøg med Diabetes Education

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guatemala

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner