Clinical trial NCT01316367: Effectiveness of PRECEDE Model for Health Education on Changes and Level of Control in Patients With Type 2 Diabetes Mellitus
Official title: Effectiveness of PRECEDE Model for Health Education on Cardiovascular Risk Reduction in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Risk Factor
Keywords: Health Promotion Education
Type 2 Diabetes Mellitus
Cardiovascular Risk Factors
Spain
Lead sponsor: Hospital Carlos III, Madrid
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 600
Sex: ALL
Minimum age (years): 31
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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.

Primary outcomes:
measure: HbA1c level
timeFrame: Final (before 2 years follow-up)
Secondary outcomes:
measure: Blood Pressure
timeFrame: Final (before 2 years follow-up)
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: Final (before 2 years of follow-up)
measure: Body Mass Index (BMI)
timeFrame: Final (before 2 years of follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Carlos III, Madrid
Study officials:
affiliation: Hospital Carlos III, Madrid
name: Miguel A Salinero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salinero-Fort MA, Carrillo-de Santa Pau E, Arrieta-Blanco FJ, Abanades-Herranz JC, Martin-Madrazo C, Rodes-Soldevila B, de Burgos-Lunar C. Effectiveness of PRECEDE model for health education on changes and level of control of HbA1c, blood pressure, lipids, and body mass index in patients with type 2 diabetes mellitus. BMC Public Health. 2011 Apr 28;11:267. doi: 10.1186/1471-2458-11-267.