Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care (DE-PLAN E)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Basque Health Service
Sponsor:
Information provided by (Responsible Party):
Carmen Silvestre Busto, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01365013
First received: June 1, 2011
Last updated: July 23, 2013
Last verified: September 2012
  Purpose

The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN Euskadi program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza-Basque Health Service) in which such intervention is implemented, compared to usual care control centers.


Condition Intervention Phase
Prediabetic State
Behavioral: DE-PLAN
Behavioral: Control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of the Translation of a Type 2 Diabetes Primary Prevention Program in Routine Context of Primary Heath Care

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Adoption of healthy lifestyles [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption

  • Incidence of Diabetes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Effectiveness of the program in the reduction of the Incidence of Diabetes


Secondary Outcome Measures:
  • Reach of the program [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Percentage of eligible participants exposed to the program

  • Implementation of the program [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Extent in which the intervention components have been delivered as intended (intervention protocol)


Estimated Enrollment: 2534
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling Behavioral: DE-PLAN
structured group or individual educational sessions (4 to 5) on diet and physical activity, plus ongoing reminder contacts (e-mails, sms, etc) during 1 year
Active Comparator: control group Behavioral: Control group
Standard advice for lifestyle change

Detailed Description:

Objective: To evaluate the feasibility and effectiveness of the DE-PLANЄ program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza) in which such intervention is implemented, compared to usual care control centers.

DESIGN AND METHODS: A phase IV cluster randomized prospective clinical trial, conducted in 14 primary care centers from Osakidetza, which will be randomly assigned to intervention or control group, that will collect a sample of 2534 followed for two years, aged 45 to 70 years without diabetes but with high risk of developing it (FINDRISC scale> 14), identified by a screening system. Nurses in intervention centers (GI) will implement DEPLANЄ for 12 months, a structured educational intervention on healthy lifestyles (diet and physical activity), while patients of the control centers will receive standard care for the prevention and treatment of type-II diabetes.

ANALYSIS: The feasibility will be reported as the reach, adoption and implementation of the program. The attributable effectiveness of the program will be determined by comparing the changes in the incidence and risk of developing diabetes in healthy habits quality of life, observed in patients exposed to DE-PLANЄ intervention and of patients from control centers. The incremental cost-utility of DE-PLANЄ program will be also analysed.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 45 to 70 years old
  • high risk of developing type-II diabetes (Findrisc scale > 14 points)

Exclusion Criteria:

  • Disorders of the cardiovascular system
  • Transplant recipients
  • Renal or hepatic failure
  • Severe chronic obstructive pulmonary disease
  • Severe mental disorders
  • Chronic and acute severe infections
  • Metabolic uncontrolled disorders
  • Restrictive pathology of muscles, bones and joints
  • Complicated pregnancy
  • Contact difficulties
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365013

Contacts
Contact: Alvaro Sanchez, PhD +34 946006637 alvaro.sanchez@osakidetza.net
Contact: Gonzalo Grandes, MD, MS +34 946006637 gonzalo.grandes@osakidetza.net

Locations
Spain
Primary Care Research Unit of Bizkaia Recruiting
Bilbao, Spain, E48014
Contact: Alvaro Sanchez         
Sponsors and Collaborators
Basque Health Service
Investigators
Principal Investigator: Carmen Silvestre Basque Health Service
Principal Investigator: Alvaro Sanchez Basque Health Service
  More Information

No publications provided by Basque Health Service

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmen Silvestre Busto, Nurse, Basque Health Service
ClinicalTrials.gov Identifier: NCT01365013     History of Changes
Other Study ID Numbers: 2010111039
Study First Received: June 1, 2011
Last Updated: July 23, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Basque Health Service:
Lifestyle
Prediabetic State
Patient Education
Primary Health Care

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

ClinicalTrials.gov processed this record on July 26, 2014