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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
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Bilbao, Spanien, E48014
- Primary Care Research Unit of Bizkaia
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Livsstilsrådgivning
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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
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Aktiv komparator: kontrollgrupp
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Standard advice for lifestyle change
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Adoption of healthy lifestyles
Tidsram: 12 months
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Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption
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12 months
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Incidence of Diabetes
Tidsram: 24 months
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Effectiveness of the program in the reduction of the Incidence of Diabetes
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24 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Reach of the program
Tidsram: 24 months
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Percentage of eligible participants exposed to the program
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24 months
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Implementation of the program
Tidsram: 24 months
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Extent in which the intervention components have been delivered as intended (intervention protocol)
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24 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Carmen Silvestre, Basque Health Service
- Huvudutredare: Alvaro Sanchez, Basque Health Service
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2010111039
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