- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01473329
Structured Diabetes Self-Management Education in Primary Care and Metabolic Control
Structured Diabetes Self-Management Education in Primary Care and Metabolic Control: a Randomized Clinical Trial.
Przegląd badań
Szczegółowy opis
Design: This was a single-center, parallel-group, randomized study Setting: One Primary Care Unit named Santa Cecília/Hospital de Clínicas de Porto Alegre Basic Unit of health, in Porto Alegre, Brazil.
Patients: Adult subjects (more than 18 years-old) up to the age of 80 years, with Type 2 diabetes, and with A1c >7%, regularly attending the primary care unit in the previous 6 months before the trial.
Exclusion criteria were: history of active infection (eg. osteomyelitis, pulmonary tuberculosis, AIDS), chronic corticosteroids use, unstable angina or myocardial infarction in the last 3 months, advanced renal disease require dialysis, heart failure (New York Heart Association class III and IV), cirrhosis, alcohol or illicit drug use, dementia, actual pregnancy or lactation, current cancer or any disease that might affect survival in the next 5 years.
Intervention: The intervention group (I) attended a five-week education course and reinforcement meetings every 4 months, for one year. The control group (C) received usual medical care.
Measures: Clinical (age, gender, ethnicity, history of hypertension and BP levels, smoking and physical activity), anthropometrical (weight, height, and waist circumference) and laboratorial data (fasting glucose levels, A1c, and lipid profile) The Diabetes knowledge was estimated by a questionnaire composed by 22 questions addressing the information discussed in the meetings and will be referred as type 2 DM knowledge score. This measures were done at 0, 4, 8 and 12 months End-points: The primary endpoint was changes in HbA1c at 4, 8 and 12 months. Additional analyses were done to evaluate changes in type 2 DM literacy, blood pressure (BP), body mass index (BMI) and lipids.
Statistical Analysis: Student t and chi-square test were used to compare baseline continuous and categorical variables, respectively. Variables with non-normal distribution were log transformed. Global linear model (GLM) for repeated measurements, with Bonferroni post-hoc test, was used to analyze changes in the outcomes during the trial. HbA1c values after the interventions were adjusted to baseline A1c and dosage of insulin at 12 months by ANCOVA. All patients with at least one A1c measurement available after randomization were included in the analyses, regardless if they attended all meetings of the education course or not (intention to treat analysis). A P value <0.05 (two-tailed) was considered significant.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- adult subjects (more than 18 years-old) up to the age of 80 years,
- with DM2 (ref ADA), and with A1c >7%,
- regularly attending a primary care unit in the previous 6 months
Exclusion Criteria:
- history of active infection (eg. osteomyelitis, pulmonary tuberculosis, AIDS),
- chronic corticosteroids use,
- unstable angina or myocardial infarction in the last 3 months,
- advanced renal disease require dialysis,
- heart failure (New York Heart Association class III and IV),
- cirrhosis,
- alcohol or illicit drug use,
- dementia,
- actual pregnancy or lactation,
- current cancer or any disease that might affect survival in the next 5 years.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Structured Diabetes education
The intervention group received a structured DSME course.
The course was composed by weekly 2 hour meetings for five weeks total hours group of 10 patient and reinforcement meetings every 4 months, for one year
|
The intervention group received a structured DSME course adapted from 15.
The course was composed by weekly 2 hour meetings for five weeks total hours group of 10 patient and reinforcement meetings every 4 months, for one year
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
HbA1c
Ramy czasowe: 4, 8 and 12 months
|
The primary endpoint was changes in HbA1c at 4, 8 and 12 months.
|
4, 8 and 12 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Changes in type 2 DM literacy.
Ramy czasowe: 4, 8 and 12 months
|
Additional analyses were done to evaluate changes in type 2 DM literacy.
|
4, 8 and 12 months
|
Changes in blood pressure (BP)
Ramy czasowe: 4, 8 and 12 months
|
Knowledge of diabetes was estimated by a questionnaire consisting of 22 knowledge scores DM
|
4, 8 and 12 months
|
Changes in Blood pressure
Ramy czasowe: 4, 8 and 12 months
|
The BP was measured twice with a digital sphygmomanometer (OMROM) with the patient in a sitting position, after a 5-min rest and with 1-min interval between measurements.
The value registered was the medium between two measures
|
4, 8 and 12 months
|
Changes in body mass index (BMI)
Ramy czasowe: 4,8 and 12 months
|
The BMI (weight/height2) was calculated
|
4,8 and 12 months
|
Changes in Lipids
Ramy czasowe: 4,8 and 12 months
|
The measure of fasting plasma total cholesterol, HDL and triglycerides were by enzymatic colorimetric method 20.
The Low-density lipoprotein cholesterol (LDL) was calculated by the formula of Friedwald equation (LDL = total cholesterol - HDL + Triglycerides/5).
|
4,8 and 12 months
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 08-464
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