Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effectiveness of PRECEDE Model for Health Education on Cardiovascular Risk Reduction in Patients With Type 2 Diabetes Mellitus
BACKGROUND: Individual health education is considered to be essential in the overall care of
patients with type 2 diabetes (DM2), although there is some uncertainty regarding its
metabolic control benefits. There have been very few randomized studies on the effects of
individual education on normal care in DM2 patients with a control group, and none of these
have assessed the long-term results. Therefore, this study aims to use this design to assess
the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational
Diagnosis, and Evaluation) education model in the metabolic control and the reduction of
cardiovascular risk factors, in patients with type 2 diabetes.
METHODS: An open community randomized clinical trial will be carried out in 8 urban
community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2
will be randomized in two groups: PRECEDE or conventional model for health promotion
education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI),
blood pressure, lipids and control criteria during the 2-year follow-up period.
Assignment to the Health Promotion Education (HPE) will be random, three centers will use
conventional HPE (the control group) and the remaining five will use PRECEDE-type HPE.
Eligible patients are selected from a list of DM2 patients by each professional using random
sampling, until the predetermined sample size is attained.
Conventional HPE is defined according to the recommendations of the Spanish Ministry of
Health National Conference on Diabetes Mellitus, and was complemented by the criteria for
good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles
among adults for 2004-2007
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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