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Trial Comparing Care in Multiple Clinics Versus Care in a Cardiac, Diabetes and Kidney Care Clinic

Primary Purpose

Kidney Diseases, Heart Diseases, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The Combined Cardiac Kidney Diabetes Care Clinic
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring Combined Clinic, Chronic Kidney Disease, Diabetes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients currently attending or who would be eligible to attend 2 or more of the following clinics: cardiac, diabetic or kidney Exclusion Criteria: Those patients currently attending the diabetic, cardiac or kidney clinics who do not have more than one condition (i.e. who have only one of the diagnoses) or who refuse to sign informed consent

Sites / Locations

  • St. Paul's Hospital

Outcomes

Primary Outcome Measures

Health care utilization and patient/provider satisfaction (5 years)

Secondary Outcome Measures

Patient outcomes (5 years)

Full Information

First Posted
September 13, 2005
Last Updated
March 14, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00175721
Brief Title
Trial Comparing Care in Multiple Clinics Versus Care in a Cardiac, Diabetes and Kidney Care Clinic
Official Title
Randomized Controlled Trial Comparing Current Care in Multiple Clinics Vs Care in a Novel Cardiac, Diabetes & Kidney Care Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the benefits of a combined cardiac, kidney, and diabetes clinic versus multiple clinics. Hypothesis: Attendance at multiple clinics by one individual patient has multiple problems which may be overcome by the introduction of a combined care clinic.
Detailed Description
This is a randomized control trial to compare health care resource utilization, and achievement of stated targets of therapy (BP, Hgb, glucose control, use of preventive medications) as well as patient and health care team satisfaction, and longer term patient outcomes in patients with kidney disease who have either or both diabetes and heart disease, and currently attend either a diabetic or heart function clinic (or both) in addition to a kidney care clinic. In addition, we will also establish and refine the specialized cross-disciplinary care model, within a framework in Vancouver, and evaluate its functioning from the perspectives of allied health and medical professionals. This is a systematic evaluation of health care delivery methods to a complex group of patients, which will serve as a nidus for ongoing research in both health outcomes research, and biomedical research. The creation of this multifaceted clinic in an organized manner would permit evaluation of all of the components of it, and also demonstrate the importance of collaboration between disciplines and between public health care initiatives and industry partners, who would fund this clinic infrastructure and research components in the initial phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Heart Diseases, Diabetes Mellitus
Keywords
Combined Clinic, Chronic Kidney Disease, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
The Combined Cardiac Kidney Diabetes Care Clinic
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
Health care utilization and patient/provider satisfaction (5 years)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Patient outcomes (5 years)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients currently attending or who would be eligible to attend 2 or more of the following clinics: cardiac, diabetic or kidney Exclusion Criteria: Those patients currently attending the diabetic, cardiac or kidney clinics who do not have more than one condition (i.e. who have only one of the diagnoses) or who refuse to sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeera Levin, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://ndt.oxfordjournals.org/content/early/2011/06/30/ndt.gfr292.abstract
Description
Related Info

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Trial Comparing Care in Multiple Clinics Versus Care in a Cardiac, Diabetes and Kidney Care Clinic

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