Back to resultsStrategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
Primary Purpose
Diabetes, Dyslipidemia, Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Counseling
Interactive Education
Group Support
Pharmacologic case management
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria: Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC) Eligible for CRRC discharge: For DM patients: HbA1c < 7.0 %, BP < 130/85 mm Hg , and LDL < 100 mg/dl; For Non-DM patients: BP < 140/90 mm Hg, and LDL < 100 mg/dl; Able and willing to sign informed consent. Exclusion Criteria: Presence of conditions that might limit long-term compliance (eg, dementia, acute psychiatric decompensation within the previous 6 months, unstable psychiatric disorder); Metastatic disease or terminal illness
Sites / Locations
- Providence VAMC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
group intervention
individual
usual care
Arm Description
pharmacist-led group intervention in behavioral and pharmacologic therapy
pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction
usual care
Outcomes
Primary Outcome Measures
The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.
Secondary Outcome Measures
Full Information
NCT ID
NCT00358033
First Posted
July 24, 2006
Last Updated
April 14, 2014
Sponsor
Providence VA Medical Center
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00358033
Brief Title
Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
Official Title
Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Providence VA Medical Center
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Dyslipidemia, Hypertension, Coronary Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group intervention
Arm Type
Experimental
Arm Description
pharmacist-led group intervention in behavioral and pharmacologic therapy
Arm Title
individual
Arm Type
Active Comparator
Arm Description
pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction
Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Type
Behavioral
Intervention Name(s)
Interactive Education
Intervention Type
Behavioral
Intervention Name(s)
Group Support
Intervention Type
Procedure
Intervention Name(s)
Pharmacologic case management
Intervention Description
Provided by clinical pharmacists
Primary Outcome Measure Information:
Title
The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC)
Eligible for CRRC discharge:
For DM patients:
HbA1c < 7.0 %,
BP < 130/85 mm Hg , and
LDL < 100 mg/dl;
For Non-DM patients:
BP < 140/90 mm Hg, and
LDL < 100 mg/dl;
Able and willing to sign informed consent.
Exclusion Criteria:
Presence of conditions that might limit long-term compliance (eg, dementia, acute psychiatric decompensation within the previous 6 months, unstable psychiatric disorder);
Metastatic disease or terminal illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chih Wu, MD
Organizational Affiliation
Providence VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VAMC
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
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