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Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst (DPA)

Primary Purpose

Diabetes Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Complex regional intervention
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All type 2 diabetes patients living in the defined intervention region
  • All caregivers involved in type 2 diabetes care in the defined intervention region

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    DPA

    VR

    Arm Description

    Regional complex intervention based on the Chronic Care Model

    Outcomes

    Primary Outcome Measures

    HBA1C

    Secondary Outcome Measures

    Total Cholesterol
    LDL-C
    HDL-C
    microalb.
    blood creatinine
    ophthalmist consults
    Statine prescriptions
    Influenza Vaccination Prescriptions

    Full Information

    First Posted
    January 15, 2009
    Last Updated
    January 15, 2009
    Sponsor
    Universiteit Antwerpen
    Collaborators
    Belgian National Health Insurance Organisation (RIZIV), University Ghent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00824499
    Brief Title
    Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst
    Acronym
    DPA
    Official Title
    Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    June 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Universiteit Antwerpen
    Collaborators
    Belgian National Health Insurance Organisation (RIZIV), University Ghent

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether regional implementation of shared care with respect to type 2 diabetes is feasible, effective and cost-effective.
    Detailed Description
    Background Diabetes is an important chronic condition with significant associated morbidity and mortality, which can be reduced by effective care. An interdisciplinary approach, sharing responsibility and involvement and education of patients are of major importance in diabetes care. In Belgium a research project aimed at creating regional diabetes shared care was set up. Research questions Is regional implementation of shared care feasible? Does it increases quality of care (evidence based care) and patient satisfaction with care? Does it have a positive effect on health status (emotional distress, overall quality of life, Hba1c)? Methods Controlled trial (July 2004 - June 2006) with a regional complex intervention comprising introduction of a care-manager and 2 community based diabetes educators, development and implementation of a shared care protocol (with a central role for the GP), regional feedback on the quality of diabetes care and patient education. Practitioners and patients participate on a voluntary basis. In the control region usual care continues. Biophysical, psychosocial and process outcomes were collected thru GP registration of patients records and self-administered patient questionnaires (PAID, QUOTE).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Type 2

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Enrollment
    375 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DPA
    Arm Type
    Experimental
    Arm Description
    Regional complex intervention based on the Chronic Care Model
    Arm Title
    VR
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Complex regional intervention
    Intervention Description
    Components of the complex intervention: Introduction of a program coordinator Introduction of a self-management education program Bottom up development of a interdisciplinary care protocol Support program for the intiation of insulin therapy in primary care Regional audit
    Primary Outcome Measure Information:
    Title
    HBA1C
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
    Secondary Outcome Measure Information:
    Title
    Total Cholesterol
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
    Title
    LDL-C
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
    Title
    HDL-C
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
    Title
    microalb.
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
    Title
    blood creatinine
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
    Title
    ophthalmist consults
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
    Title
    Statine prescriptions
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006
    Title
    Influenza Vaccination Prescriptions
    Time Frame
    Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All type 2 diabetes patients living in the defined intervention region All caregivers involved in type 2 diabetes care in the defined intervention region Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Van Royen, Prof. Ph.D. M.D.
    Organizational Affiliation
    Universiteit Antwerpen
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Jan De Maeseneer, Prof. Ph.D. M.D.
    Organizational Affiliation
    University of Ghent
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25145469
    Citation
    Sunaert P, Willems S, Feyen L, Bastiaens H, De Maeseneer J, Jenkins L, Nobels F, Samyn E, Vandekerckhove M, Wens J, De Sutter A. Engaging GPs in insulin therapy initiation: a qualitative study evaluating a support program in the Belgian context. BMC Fam Pract. 2014 Aug 21;15:144. doi: 10.1186/1471-2296-15-144.
    Results Reference
    derived
    PubMed Identifier
    20630062
    Citation
    Sunaert P, Bastiaens H, Nobels F, Feyen L, Verbeke G, Vermeire E, De Maeseneer J, Willems S, De Sutter A. Effectiveness of the introduction of a Chronic Care Model-based program for type 2 diabetes in Belgium. BMC Health Serv Res. 2010 Jul 14;10:207. doi: 10.1186/1472-6963-10-207.
    Results Reference
    derived
    PubMed Identifier
    19698185
    Citation
    Sunaert P, Bastiaens H, Feyen L, Snauwaert B, Nobels F, Wens J, Vermeire E, Van Royen P, De Maeseneer J, De Sutter A, Willems S. Implementation of a program for type 2 diabetes based on the Chronic Care Model in a hospital-centered health care system: "the Belgian experience". BMC Health Serv Res. 2009 Aug 23;9:152. doi: 10.1186/1472-6963-9-152.
    Results Reference
    derived

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    Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes: Diabetes Project Aalst

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