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

15 mars 2011 uppdaterad av: Hospital Carlos III, Madrid

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

600

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Spanien
      • Madrid, Spanien, 28029
        • Hospital Carlos III, Madrid

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

31 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Beteende: 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.
Experimentell: PRECEDE HPE model
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
HbA1c level
Tidsram: Final (before 2 years follow-up)
Final (before 2 years follow-up)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood Pressure
Tidsram: Final (before 2 years follow-up)
Systolic and Diastolic Blood Pressure
Final (before 2 years follow-up)
Low-density lipoprotein (LDL) cholesterol
Tidsram: Final (before 2 years of follow-up)
Final (before 2 years of follow-up)
Body Mass Index (BMI)
Tidsram: Final (before 2 years of follow-up
Final (before 2 years of follow-up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospital Carlos III, Madrid

Utredare

  • Huvudutredare: Miguel A Salinero, MD, Hospital Carlos III, Madrid

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2003

Primärt slutförande (Faktisk)

1 februari 2005

Avslutad studie (Faktisk)

1 mars 2005

Studieregistreringsdatum

Först inskickad

15 mars 2011

Först inskickad som uppfyllde QC-kriterierna

15 mars 2011

Första postat (Uppskatta)

16 mars 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

16 mars 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 mars 2011

Senast verifierad

1 mars 2003

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HCIII-0106
  • PI02-0567 (Annat bidrag/finansieringsnummer: Fondo de Investigación Sanitaria)

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