Effectiveness of PRECEDE Model for Health Education on Changes and Level of Control in Patients With Type 2 Diabetes Mellitus

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Cardiovascular Risk Factor
• Interventions: Behavioral: CHPE; Behavioral: PRECEDE HPE model

• Registration Number: NCT01316367
• Lead Sponsor: Hospital Carlos III, Madrid

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2003-02
• Status Verified: 2003-03
• Primary Completion: 2005-02
• Study Completion: 2005-03
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Last Update Submitted: 2011-03-15
• Study First Posted: 2011-03-16
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Older than 30 years of age, with previously diagnosed DM2 (cardinal clinical, plus random blood glucose > 200 mg/dl or oral glucose of > 200 mg/dl at 2 h, twice, or plasma fasting glucose of > 126 mg/dl on two occasions or being diagnosed previously, received specific treatment for DM2)

Exclusion Criteria

• Gestational diabetes
• Patients involved in clinical trials
• Patients with life expectancy less than 1 year (according to clinical judgment)
• Patients who refused to participate
• Homebound patients Patients meeting criteria for inclusion and not meeting any exclusion criteria were invited to participate, and were included after accepting and signing an informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Health Promotion Education (CHPE).	CHPE	The CHPE model was defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, which was complemented by criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults (2004-2007). The model is based on the following aspects: self-monitoring of glycaemic control, physical exercise, diet, weight management, and times of the day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control, medication adherence and smoking cessation.
PRECEDE HPE model	PRECEDE HPE model	-

Primary Outcome Measures

Name	Time	Method
HbA1c level	Final (before 2 years follow-up)

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	Final (before 2 years follow-up)	Systolic and Diastolic Blood Pressure
Low-density lipoprotein (LDL) cholesterol	Final (before 2 years of follow-up)
Body Mass Index (BMI)	Final (before 2 years of follow-up

Trial Locations

Locations (1)

Hospital Carlos III, Madrid; 🇪🇸 Madrid, Spain