- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Texas
-
Austin, Texas, Vereinigte Staaten, 78701
- The University of Texas at Austin
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Sharon A. Brown, The University of Texas at Austin
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BROWNS (completed)
- R01DK048160 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Diabetes mellitus, nicht insulinabhängig
-
Tokat Gaziosmanpasa UniversityAtaturk UniversityNoch keine RekrutierungDiabetes mellitus | Insulin-Selbstmanagement
-
Izmir Bakircay UniversityAbgeschlossenDiabetes mellitus, Typ 2 | Diabetes Mellitus, Typ 2 mit Insulin behandeltTürkei (türkiye)
-
Kaohsiung Medical University Chung-Ho Memorial...AbgeschlossenTyp 2 Diabetes mellitus | Insulin | Ausbildung
-
King Edward Medical UniversityAbgeschlossenBewertung der glykämischen Kontrolle von Insulin Glargin in Kombination mit normalem Insulin bei Typ-1-Diabetes bei KindernPakistan
-
Shanghai Zhongshan HospitalAbgeschlossenDiabetes Mellitus Typ 2 – mit Insulin behandeltChina
-
Linda SiminerioSanofiBeendetDiabetes Mellitus Typ 2 – mit Insulin behandeltVereinigte Staaten
-
Medtronic MiniMed, Inc.Aktiv, nicht rekrutierend
-
HealthPartners InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... und andere MitarbeiterAbgeschlossenDiabetes | InsulinVereinigte Staaten
-
Hospital Universitario San IgnacioRekrutierungDiabetes Mellitus, Typ 2 mit Insulin behandeltKolumbien
-
Semmelweis UniversityNoch keine RekrutierungDiabetes (Insulin-Erfassung, Typ 1 oder Typ 2)Ungarn
Klinische Studien zur Schulung zum Diabetes-Selbstmanagement
-
Kutahya Health Sciences UniversityAbgeschlossenDiabetes mellitus, Typ 2 | Patientenermächtigung | ErmächtigungTruthahn
-
LMC Diabetes & Endocrinology Ltd.Abgeschlossen
-
LMC Diabetes & Endocrinology Ltd.Abbott Diabetes CareNoch keine Rekrutierung
-
University of ArizonaAbgeschlossen
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Rekrutierung
-
Omada Health, Inc.Abbott Diabetes Care; Evidation HealthAbgeschlossenTyp 2 DiabetesVereinigte Staaten
-
University of ArkansasNational Institute on Minority Health and Health Disparities (NIMHD)AbgeschlossenTyp 2 DiabetesVereinigte Staaten
-
University of Southern CaliforniaAbgeschlossenDepression | Diabetes | HerzkrankheitVereinigte Staaten
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AbgeschlossenTyp 2 Diabetes mellitusVereinigte Staaten
-
HSIN LING CHENNational Taipei University of Nursing and Health SciencesRekrutierung