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A Self-care Intervention for Latino Adults With Diabetes

The purpose of this study is to modify and evaluate a culturally appropriate intervention that is designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment and diabetes knowledge among Latino adults over the age of 55 years.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

It is recognized that Latinos with diabetes experience substantially worse process and outcomes of care. To address this problem, the goal of the proposed study is to modify and evaluate a culturally appropriate intervention designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment, and diabetes-specific knowledge among Latino adults over the age of 55 years. Specific aims of the project are: 1) to modify an existing empowerment intervention to improve self-care skills among Latinos with diabetes; 2) to test the effect of a patient-centered culturally-tailored intervention that focuses on increasing self-efficacy, knowledge about diabetes care, and self-care skills among Latinos with diabetes on: a) biophysiological endpoints such as glycemic control; b) self-efficacy, diabetes-specific knowledge, and self-care behaviors; c) psychosocial endpoints such as quality of life; and d) total costs and cost-effectiveness of care; and 3) to test the effect of the intervention on compliance with indicators of good process of diabetes care. To evaluate the effectiveness of the intervention, the research team will conduct a controlled clinical trial that will randomize 300 Latino adults over the age of 55 years with diabetes who are cared for in 4 public clinics affiliated with the Martin Luther King/Drew University Medical Center. Randomization will occur at the patient level. The primary endpoints for the trial will be: 1) differences in glycemic control as reflected by mean difference in hemoglobin A1c over time for the intervention versus usual care control group; and 2) difference in diabetes-specific quality of life over time. The trial will also measure a number of important secondary endpoints both before and after exposure to the intervention: self-efficacy, knowledge about diabetes, self-care behaviors, diabetes-specific symptoms, quality of life, low density lipoprotein levels, blood pressure, weight, quality of care, and costs. Variables that are likely to modify the effectiveness of the intervention will also be examined, including acculturation, language, insurance status, and social support. These data will provide the needed information to evaluate both the effectiveness and the cost effectiveness of the patient-centered intervention among Latino adults with diabetes. In summary, by modifying and testing an empowerment intervention that focuses on the patient, we hope to arm Latino adults with diabetes with the needed self-efficacy, knowledge, and self-care skills to have the best possible glycemic control and process of health care regardless of the resources available in their care setting.

Undersøgelsestype

Interventionel

Tilmelding

300

Fase

  • Fase 2

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

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Self-Identify as having diabetes, be 55 years of age or older, Latino/a and have a hemoglobing A1c of 8% or greater.

Exclusion Criteria:

Non diabetic, under 55, non Latino/a, a hemoglobin A1c of less than 8%.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Change in hemoglobin A1c.

Sekundære resultatmål

Resultatmål
Change in blood pressure, cholesterol, and weight.

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Carol M Mangione, M.D., MSPH, University of California, Los Angeles

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.

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 2004

Studieafslutning

1. maj 2006

Datoer for studieregistrering

Først indsendt

7. december 2005

Først indsendt, der opfyldte QC-kriterier

8. december 2005

Først opslået (Skøn)

9. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. marts 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. marts 2010

Sidst verificeret

1. marts 2010

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DK59527 (completed)
  • 5R01DK059527-04 (U.S. NIH-bevilling/kontrakt)

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 Forhøjet blodtryk

Kliniske forsøg med Empowerment

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