Improving the Care of Diabetic Patients: A Randomized Trial of a Family Physician Office-Based Chronic Disease Care Model for Patients With Type 2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00789282|
Recruitment Status : Terminated (Recruitment challenges.)
First Posted : November 11, 2008
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Other: multidisciplinary approach Other: multifactorial approach - for enhanced care group Other: reflects current patterns of care|
This is a single-blinded, two-arm, randomized clinical trial of patients with type 2 diabetes mellitus that will compare 'usual care' with an 'enhanced care' model of chronic disease management that is based in the practices of family physicians participating in Primary Care Networks (PCN's).
In this study, patients will be randomized into:
- Usual care (control) Will reflect current patterns of care for patients with type 2 diabetes in the Capital Health region.
Enhanced Care (intervention) Will receive a multifactorial intervention with three main components that include:
- optimized medical management,
- support for development of enhanced patient self care management skills, and
- organized proactive follow-up by chronic disease management (CDM) teams to support improvements in care.
These components are key elements of the Chronic Care Model. They will be delivered by CDM teams working in the practices family physicians in the Primary Care Networks (PCN's).
Clinical Outcome Measures
- will be assessed at baseline, 3 months, and 6 months.
Quality of Life Measures
- will be measured at baseline, 6 months, and 12 months.
Risks and Benefits
The prevalence of diabetes mellitus is high and expected to increase in the future. It is unlikely that current systems of care will be adequate to provide care to patients with diabetes in the future. This study will evaluate a model of care of care , based on the Chronic Care Model, which has been provided to improve the care of patients with chronic diseases like diabetes. Patients may benefit due to improved care for their diabetes. Health care providers may benefit through an increased understanding of best methods and organization to provide care to populations of patients with diabetes and other chronic diseases.
Privacy and Confidentiality:
All study data collected will be kept confidential. Respondents will not be identified by name in any presentation or publications arising from the study. Access to data is restricted to investigators and project staff.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Single-blinded, Two-arm, Randomized Clinical Trial of Patients With Type 2 Diabetes Mellitus That Will Compare'Usual Care' With an 'Enhanced Care' Model of Chronic Disease Management That is Based in the Practices of Family Physicians Participating in Primary Care Networks (PCN's).|
|Study Start Date :||February 2008|
|Primary Completion Date :||February 2011|
|Study Completion Date :||December 2011|
Active Comparator: Usual Care Group
The 'usual care' study arm (control) will reflect current patterns of care for patients with thpe 2 diabetes in the Capital Health region
Other: reflects current patterns of care
Continue under the care of their family physician and specialists with referral to diabetic assessment and treatment centers at the discretion of the patient and physician.
Normal manner of care: could attend diabetic self education classes and consultations regarding management of diabetes. Or, participate in other patient self management program of their choice.
Experimental: Enhanced Care Group
In the enhanced care group(intervention arm) the participants will receive a multifactorial intervention with three main components that include: optimized medical management, 2) support for development of enhanced patient self management skills, and 3) organized proactive follow-up by chronic disease management teams to support improvement in care.
Other: multidisciplinary approach
Provides an integrated, proactive approach to the management of patients with chronic diseases (ie: diabetes and sequelae) Wagner Model- care encompassed in 3 overlapping galaxies: wider community; the health care system; and the provider organization. There are 6 essential elements: community resources and policies; health care organization; patient self-management support; delivery system design; decision support; and clinical information systems.Other: multifactorial approach - for enhanced care group
optimized medical management support for development of enhanced patient self management skills organized proactive follow-up chronic disease management teams
- A higher proportion of patients with type 2 diabetes enrolled in the 'enhanced care' arm compared with the patients enrolled 'usual' care' arm will achieve an absolute reduction in their HbaA1c of 1.0% or greater during the study period. [ Time Frame: 1 year ]
- A higher proportion of patients with type 2 diabetes in the 'enhanced care' arm compared with the patients enrolled in 'usual care' arm will achieve a 10% or greater reduction in HbA1c values during the study period. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789282
|University of Alberta, Dept of Family Medicicne|
|Edmonton, Alberta, Canada, T6G - 2C8|
|Principal Investigator:||Neil Bell, MD,MSc,CCFP,FCFP||Professor, Dept of Family Medicine, University of Alberta|