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

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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetic State
• Intervention / Treatment: Behavioral: DE-PLAN; Behavioral: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 1113
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Bilbao, Spain, E48014
    • Primary care research unit of Bizkaia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption of healthy lifestyles	Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption	12 months
Incidence of Diabetes	Effectiveness of the program in the reduction of the Incidence of Diabetes	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of the program	Percentage of eligible participants exposed to the program	24 months
Implementation of the program	Extent in which the intervention components have been delivered as intended (intervention protocol)	24 months

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Principal Investigator: Carmen Silvestre, Basque Health Service; Principal Investigator: Alvaro Sanchez, Basque Health Service

Publications and helpful links

General Publications

• Sanchez A, Silvestre C, Campo N, Grandes G; PreDE research group. Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study. Trials. 2016 May 20;17(1):254. doi: 10.1186/s13063-016-1379-0.
• Sanchez A, Silvestre C, Sauto R, Martinez C, Grandes G; PreDE research group. Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial. BMC Fam Pract. 2012 Nov 16;13:109. doi: 10.1186/1471-2296-13-109.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Primary Health Care; Patient Education; Lifestyle; Prediabetic State
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 2010111039