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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
HbA1c
Tijdsspanne: 4, 8 and 12 months
|
The primary endpoint was changes in HbA1c at 4, 8 and 12 months.
|
4, 8 and 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Changes in type 2 DM literacy.
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 4,8 and 12 months
|
The BMI (weight/height2) was calculated
|
4,8 and 12 months
|
Changes in Lipids
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 08-464
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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NMP Medical Research InstituteVoltooid
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Centers for Disease Control and PreventionVoltooidHIV-infecties | Hepatitis CVerenigde Staten
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Rigshospitalet, DenmarkFrederiksberg University Hospital; Defactum, Central Denmark RegionActief, niet wervend