- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00004983
Education and Group Support for Diabetic Hispanics
The purpose of this ongoing work in Starr County, located on the Texas-Mexico border, is to conduct clinical studies to determine the effectiveness of diabetes self-management programs designed specifically for Mexican Americans. The programs meet national standards for diabetes self-management education. They are provided in community settings with the primary purpose of improving the health of Mexican Americans with diabetes and their family members, who either have diabetes or are at risk for developing diabetes.
The diabetes self-management programs are provided in Spanish and are directed by bilingual Hispanic clinical nurse specialists, dietitians, and community health workers. Key elements of the programs include instruction on nutrition, self-monitoring of blood glucose, exercise, and other diabetes self-management topics, as well as group support to promote behavioral changes.
In the original study (1994-1998), 256 Mexican American adults diagnosed with type 2 diabetes and 256 family members or other support persons were enrolled. For one year, the people with diabetes, along with their family members, attended small group sessions held in churches, community health clinics, adult day care centers, and schools. Information on the effectiveness of the program was collected at 3, 6, and 12 months; and annually thereafter.
Findings of the original study suggested that the program had a positive impact on diabetes metabolic control. Levels of diabetes knowledge and rates of glucose self-monitoring and attendance suggested that a shorter program - one that incorporated critical elements of the previous successful strategy - might result in similar improvements. Thus, the goal of the new study, funded in June 1999, was to shorten the original program and to compare it to the previous successful program in terms of short- and long-term health outcomes.
To identify key components of the previous program, we are exploring differences between subjects who successfully integrated self-care components of the program and who experienced significant improvements in metabolic control and those who were not as successful. The program is being revised and shortened, based on this information. Beginning in April 2000, we will start recruiting participants for the clinical trial of the revised program.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Texas
-
Austin, Texas, Förenta staterna, 78701
- The University of Texas at Austin
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Diagnosed with type 2 diabetes ([a] two verifiable FBS test results of 140 mg/dl or above or [b] taking or have taken insulin or hypoglycemic agents for at least one year in the past)
- Willing to participate
- A family member, preferably a spouse or first-degree relative, who agrees to participate
Exclusion Criteria:
- Migrant farm workers (not available for the year-long program)
- Pregnant
- Medical conditions for which changes in diet and exercise levels would be contraindicated
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
Samarbetspartners och utredare
Utredare
- Huvudutredare: Sharon A. Brown, The University of Texas at Austin
Publikationer och användbara länkar
Allmänna publikationer
- Brown SA. Meta-analysis of diabetes patient education research: variations in intervention effects across studies. Res Nurs Health. 1992 Dec;15(6):409-19. doi: 10.1002/nur.4770150603.
- Brown SA, Hanis CL. A community-based, culturally sensitive education and group-support intervention for Mexican Americans with NIDDM: a pilot study of efficacy. Diabetes Educ. 1995 May-Jun;21(3):203-10. doi: 10.1177/014572179502100307.
- Brown SA, Hanis CL. Culturally competent diabetes education for Mexican Americans: the Starr County Study. Diabetes Educ. 1999 Mar-Apr;25(2):226-36. doi: 10.1177/014572179902500208.
- Brown SA, Upchurch SL, Garcia AA, Barton SA, Hanis CL. Symptom-related self-care of Mexican Americans with type 2 diabetes: preliminary findings of the Starr County Diabetes Education Study. Diabetes Educ. 1998 May-Jun;24(3):331-9. doi: 10.1177/014572179802400308.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BROWNS (completed)
- R01DK048160 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Diabetes mellitus, icke-insulinberoende
-
King Edward Medical UniversityAvslutadAtt bedöma den glykemiska kontrollen av insulin Glargine i kombination med vanligt insulin hos typ 1-diabetes hos barnPakistan
-
Kaohsiung Medical University Chung-Ho Memorial...AvslutadTyp 2-diabetes mellitus | Insulin | Utbildning
-
Hospital Universitario San IgnacioRekryteringDiabetes mellitus, typ 2 behandlad med insulinColombia
-
Samsung Medical CenterMinistry of Trade, Industry & Energy, Republic of Korea; Korea Evaluation... och andra samarbetspartnersAvslutadDiabetes mellitus | Insulinberoende diabetes mellitus | Insulin HypoglykemiKorea, Republiken av
-
Goztepe Prof Dr Suleyman Yalcın City HospitalAvslutadDiabetes mellitus, typ 2 | Utbildningsproblem | Injektionsställe | Insulin injektionsdyna | InsulinimplementeringsfelKalkon
-
HealthPartners InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) och andra samarbetspartnersAvslutadDiabetes | InsulinFörenta staterna
-
Steno Diabetes Center CopenhagenAvslutadDiabetes mellitus, typ 1 | Insulin HypoglykemiDanmark
-
Klavs Würgler HansenSteno Diabetes Center Aarhus, DenmarkRekryteringTyp 2-diabetes behandlad med insulinDanmark
-
Woodlands Health CampusTan Tock Seng HospitalRekryteringTyp 2-diabetes behandlad med insulinSingapore
-
Boston Medical CenterNovo Nordisk A/SAvslutadTyp 2-diabetes behandlad med insulinFörenta staterna
Kliniska prövningar på utbildning för självhantering av diabetes
-
University of NottinghamAvslutadDiabetes mellitus, typ 2 | HälsobeteendeJordanien
-
University of MichiganNational Institutes of Health (NIH); National Institute on Aging (NIA); Blue...Avslutad
-
University of MichiganRekrytering
-
Mutah UniversityAvslutad
-
Kutahya Health Sciences UniversityAvslutadDiabetes mellitus, typ 2 | Patient Empowerment | BemyndigandeKalkon
-
US Department of Veterans AffairsIndiana University School of MedicineAvslutadHjärtsviktFörenta staterna
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Avslutad
-
LMC Diabetes & Endocrinology Ltd.Avslutad
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Rekrytering
-
Omada Health, Inc.Palo Alto Medical Foundation; Sutter HealthAvslutadDiabetes typ 2Förenta staterna