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Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

25. august 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

1875

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Standard Care
Vanlig omsorg
Eksperimentell: 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.
Atferdsmessig: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Jaeb Center for Health Research

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2011

Primær fullføring (Faktiske)

1. juli 2014

Studiet fullført (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først innsendt

24. mars 2011

Først innsendt som oppfylte QC-kriteriene

24. mars 2011

Først lagt ut (Anslag)

25. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DRCR.net-Protocol M

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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