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Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

25 agosto 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1875

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Cura standard
Solita cura
Sperimentale: 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.
Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in HbA1c
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diabetes Care Knowledge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Jaeb Center for Health Research

Collaboratori

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

Investigatori

  • Cattedra di studio: Lloyd P Aiello, M.D., Joslin Diabetes Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2011

Completamento primario (Effettivo)

1 luglio 2014

Completamento dello studio (Effettivo)

1 gennaio 2015

Date di iscrizione allo studio

Primo inviato

24 marzo 2011

Primo inviato che soddisfa i criteri di controllo qualità

24 marzo 2011

Primo Inserito (Stima)

25 marzo 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 agosto 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 agosto 2016

Ultimo verificato

1 agosto 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DRCR.net-Protocol M

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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