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

This study has been completed.
Sponsor:
Information provided by:
Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier:
NCT01316367
First received: March 15, 2011
Last updated: NA
Last verified: March 2003
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Cardiovascular Risk Factor
 Behavioral: PRECEDE HPE model
Behavioral: CHPE
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of PRECEDE Model for Health Education on Cardiovascular Risk Reduction in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Carlos III, Madrid:

Primary Outcome Measures:
  • HbA1c level [ Time Frame: Final (before 2 years follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Final (before 2 years follow-up) ] [ Designated as safety issue: No ]
    Systolic and Diastolic Blood Pressure

  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: Final (before 2 years of follow-up) ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Time Frame: Final (before 2 years of follow-up ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: February 2003
Study Completion Date: March 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Health Promotion Education (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.
 Behavioral: 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.
Experimental: PRECEDE HPE model Behavioral: PRECEDE HPE model

The model considers the influence of the following three factors on health-related behavior:

  • Predisposing: factors influencing the patient's motivation to undertake the behavior to be analyzed or encouraged.
  • Facilitators: factors influencing the level of easiness or difficulty the patient and his/her family have in undertaking a given behavior.
  • Reinforcing: factors arising after the patient has undertaken the behavior, and which reward or punish it.

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

  Eligibility

Ages Eligible for Study:   31 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316367

Locations
Spain
Hospital Carlos III, Madrid
Madrid, Spain, 28029
Sponsors and Collaborators
Hospital Carlos III, Madrid
Investigators
Principal Investigator: Miguel A Salinero, MD Hospital Carlos III, Madrid
  More Information

No publications provided by Hospital Carlos III, Madrid

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Miguel Ángel Salinero Fort, Hospital Carlos III
ClinicalTrials.gov Identifier: NCT01316367     History of Changes
Other Study ID Numbers: HCIII-0106, PI02-0567
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Carlos III, Madrid:
Health Promotion Education
Type 2 Diabetes Mellitus
Cardiovascular Risk Factors
Spain

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013