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The Diabetes TeleCare Study (DTC)

Bridging Barriers to Diabetes Care With Telemedicine: The Diabetes TeleCare Study (DTC)

The American Diabetes Association clinical care guidelines stress the importance of metabolic control to prevent complications and improve quality of life for persons with diabetes. Unfortunately, these guidelines have not had widespread acceptance into clinical practice. Therefore, we propose translational research to evaluate telemedicine technology using interactive video conferencing (Diabetes TeleCare) as a novel means to increase the availability of health professionals in rural communities for the effective delivery of a diabetes self-management education program and as a means to provide retinal screenings in the primary care setting.

Studieoversikt

Detaljert beskrivelse

According to recent 2002 estimates, the yearly cost of diabetes was approximately $132 billion. The burden of diabetes is considerable, particularly for ethnically diverse populations. Disease management programs that focus on self-management education have been effective in improving metabolic control. Accordingly, the American Diabetes Association clinical care guidelines stress the importance of metabolic control to prevent complications and improve quality of life for persons with this disease. Unfortunately, these advances have not resulted in widespread acceptance into clinical practice. Therefore, we propose translational research to evaluate telemedicine technology using interactive video conferencing (Diabetes TeleCare) as a novel means to increase the availability of health professionals in rural communities for the effective delivery of a diabetes self-management education program and as a means to provide retinal screenings in the primary care setting. Our aims are to 1) develop and implement a 12-month intervention, Diabetes TeleCare to improve adherence to diabetes clinical care guidelines and improve diabetes control in two community health centers located in ethnically diverse, rural and medically underserved communities, 2) conduct a one-year randomized clinical trial (RCT) of 200 patients to formally evaluate the effectiveness of Diabetes TeleCare compared to Usual Care in a sample with >60% African-Americans, and 3) determine the cost-effectiveness and satisfaction of Diabetes TeleCare compared to Usual Care. Participants are recruited from two community health centers in rural South Carolina and randomized according to a patient randomization schedule. Diabetes TeleCare (a structured curriculum) is delivered by a team consisting of a registered nurse/certified diabetes educator (RN-CDE) and an experienced registered dietitian, with support by other health professionals who are linked by interactive video conferencing to participants (single and group) in rural health centers at distant locations. The primary outcomes are measures of metabolic control (A1c, lipids), blood pressure, and use of the telemedicine-facilitated retinal screening capacity. Secondary outcomes include satisfaction, quality of life, health beliefs, and knowledge. The economic analysis will include an assessment of resource utilization, cost, and health utilities. In addition, incremental reductions in costs per A1c and the estimated lifetime cost-utility of Diabetes TeleCare compared to usual care will be determined. Telemedicine may be an effective alternative to traditional health care delivery systems resulting in improved diabetes education and control.

The intervention goal was to achieve an A1c <7%, with secondary goals of 10% weight loss and increasing exercise to at least 30 minutes a day, 5 days a week. Participants attend 13 sessions, 2 in the first month (1 group, 1 individual), monthly thereafter (9 group, 2 individual). Three group sessions were conducted in-person, all others were conducted via telemedicine. The self-management education team consisted of an RN/CDE and an RD. Sessions were conducted remotely, with a trained facilitator (LPN) at the clinic site. Participants were given a notebook and new material was added at each session. Completion of self-monitoring logs, including blood sugar, diet and physical activity, was assigned daily followed by less frequently based on progress towards intervention goals.

Studietype

Intervensjonell

Registrering (Faktiske)

165

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • South Carolina
      • Bennettsville, South Carolina, Forente stater, 29512
        • CareSouth Bennettsville

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

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • All participants must have a confirmed physician diagnosis of type 2 diabetes supported by American Diabetes Association diagnostic criteria for blood glucose levels or
  • Current use of oral hypoglycemic agents or insulin as confirmed by brief medical record review.
  • All adults (> 21 years of age) who have a A1c value > 7.0 will be eligible.

Exclusion Criteria:

  • Exclusion criteria applies to individuals with limitations that could limit safe participation in the study,

    • such as metastatic cancer,
    • multiple or recent (within six months) myocardial infarction (MI) or stroke,
    • dialysis for end stage renal disease,
    • severe psychiatric disease or dementia, or
    • inability to walk without an assistive device.
  • We will also exclude women who are pregnant at the time of study recruitment (based on self report only) because of the unique needs related to diabetes self-management during pregnancy.
  • We will, however, retain women in the study should they become pregnant during the course of the project.
  • Individuals will be excluded if they plan to move out of the area.
  • Additional exclusions may include inability to complete baseline tasks to the satisfaction of the lead interventionist or other more subjective assessment suggesting inability or unwillingness to adhere reasonably to the intervention based on interventionist review.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Innblanding
A 12-month diabetes self-management intervention delivered via telemedicine, with opportunity to receive telemedicine-based screening eye exam, was conducted.
Aktiv komparator: Vanlig omsorg
Upon randomization, received one 15-minute diabetes self-management individual session, using American Diabetes Association materials. Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Hemoglobin A1c
Tidsramme: 6 mths, 12 mths, 24 mths
6 mths, 12 mths, 24 mths

Sekundære resultatmål

Resultatmål
Tidsramme
Blood pressure
Tidsramme: 6 mths, 12 mths, 24 mths
6 mths, 12 mths, 24 mths
LDL Cholesterol
Tidsramme: 6 mths, 12 mths, 24 mths
6 mths, 12 mths, 24 mths
Cost effectiveness and cost utility
Tidsramme: 6 mths, 12 mths
6 mths, 12 mths
Retinal examination rates
Tidsramme: 12 months
12 months
Weight
Tidsramme: 6 mths, 12 mths, 24 mths
6 mths, 12 mths, 24 mths
Waist Circumference
Tidsramme: 6 mths, 12 mths, 24 mths
6 mths, 12 mths, 24 mths

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Richard M Davis, MD, University of South Carolina

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.

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 (Faktiske)

1. september 2005

Primær fullføring (Faktiske)

1. november 2008

Studiet fullført (Faktiske)

1. november 2008

Datoer for studieregistrering

Først innsendt

6. februar 2006

Først innsendt som oppfylte QC-kriteriene

6. februar 2006

Først lagt ut (Anslag)

7. februar 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. februar 2018

Sist bekreftet

1. februar 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • R18 67312 (completed)
  • R18DK067312 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Kliniske studier på Diabetes mellitus, type 2

Kliniske studier på Usual Care

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