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

Prediabetic State Clinical Trial

— DE-PLAN E  

Official title:

Effectiveness of the Translation of a Type 2 Diabetes Primary Prevention Program in Routine Context of Primary Heath Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365013
• Other study ID #: 2010111039
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2011
• Last updated: July 28, 2016
• Start date: June 2011
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1113
• Est. completion date: July 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prediabetic State

Intervention

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
• Control group
Standard advice for lifestyle change

Locations

Country	Name	City	State
Spain	Primary Care Research Unit of Bizkaia	Bilbao

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adoption of healthy lifestyles	Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption	12 months	No
Primary	Incidence of Diabetes	Effectiveness of the program in the reduction of the Incidence of Diabetes	24 months	No
Secondary	Reach of the program	Percentage of eligible participants exposed to the program	24 months	No
Secondary	Implementation of the program	Extent in which the intervention components have been delivered as intended (intervention protocol)	24 months	No