Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care (DE-PLAN E)
Primary Purpose
Prediabetic State
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
DE-PLAN
Control group
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetic State focused on measuring Lifestyle, Prediabetic State, Patient Education, Primary Health Care
Eligibility 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
Sites / Locations
- Primary Care Research Unit of Bizkaia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lifestyle counseling
control group
Arm Description
Outcomes
Primary Outcome Measures
Adoption of healthy lifestyles
Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption
Incidence of Diabetes
Effectiveness of the program in the reduction of the Incidence of Diabetes
Secondary Outcome Measures
Reach of the program
Percentage of eligible participants exposed to the program
Implementation of the program
Extent in which the intervention components have been delivered as intended (intervention protocol)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01365013
Brief Title
Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care
Acronym
DE-PLAN E
Official Title
Effectiveness of the Translation of a Type 2 Diabetes Primary Prevention Program in Routine Context of Primary Heath Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Lifestyle, Prediabetic State, Patient Education, Primary Health Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
DE-PLAN
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Standard advice for lifestyle change
Primary Outcome Measure Information:
Title
Adoption of healthy lifestyles
Description
Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption
Time Frame
12 months
Title
Incidence of Diabetes
Description
Effectiveness of the program in the reduction of the Incidence of Diabetes
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Reach of the program
Description
Percentage of eligible participants exposed to the program
Time Frame
24 months
Title
Implementation of the program
Description
Extent in which the intervention components have been delivered as intended (intervention protocol)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Silvestre
Organizational Affiliation
Basque Health Service
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alvaro Sanchez
Organizational Affiliation
Basque Health Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Care Research Unit of Bizkaia
City
Bilbao
ZIP/Postal Code
E48014
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
27206733
Citation
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.
Results Reference
derived
PubMed Identifier
23158830
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care
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