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Reducing Total Cardiovascular Risk in an Urban Community (COACH)

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ClinicalTrials.gov Identifier: NCT00241904
Recruitment Status : Completed
First Posted : October 19, 2005
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Cardiovascular Diseases
Heart Diseases
Coronary Disease
Diabetes Mellitus
Atherosclerosis
Cerebral Arteriosclerosis
Hypertension
Interventions Behavioral: Lifestyle Changes
Drug: Antiplatelet Agents
Drug: Beta Blocker
Drug: ACE Inhibitors
Enrollment 525
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Comprehensive Intervention Group Less Intensive Intervention (Usual Care) Group
Hide Arm/Group Description

Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms.Participants will receive a LI intervention providing feedback on CVD risk factors and guidelines to patients and their physicians.

Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors: Oral medications, received 1-2 times per day

Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.
Period Title: Overall Study
Started 261 264
Completed 227 240
Not Completed 34 24
Arm/Group Title Comprehensive Intervention Less Intensive Intervention Total
Hide Arm/Group Description CI intervention will receive Behavioral: Lifestyle Changes, Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercises, as well as pharmacologic agents LI Arm: Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians. Total of all reporting groups
Overall Number of Baseline Participants 261 264 525
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 261 participants 264 participants 525 participants
54.3  (12) 54.7  (11.5) 54.5  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 264 participants 525 participants
Female
187
  71.6%
187
  70.8%
374
  71.2%
Male
74
  28.4%
77
  29.2%
151
  28.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 264 participants 525 participants
Black
207
  79.3%
210
  79.5%
417
  79.4%
White
54
  20.7%
54
  20.5%
108
  20.6%
1.Primary Outcome
Title Low-density Lipoprotein Cholesterol
Hide Description Blood was drawn after a 12 hour fast and low density lipoprotein cholesterol was measured in a standardized lab
Time Frame Measured at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Intervention Group Less Intensive Intervention Group
Hide Arm/Group Description:

Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..

Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors: Oral medications, received 1-2 times per day

Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors: Oral medications, received 1-2 times per day

Overall Number of Participants Analyzed 261 264
Mean (Standard Deviation)
Unit of Measure: mg/dL
100.1  (39.2) 110.6  (36.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comprehensive Intervention Group, Less Intensive Intervention Group
Comments Intention to treat analysis was used
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method General Linear Mixed Model
Comments [Not Specified]
2.Primary Outcome
Title Systolic Blood Pressure
Hide Description Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association.
Time Frame Measured at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Intervention Group Less Intensive Intervention Group
Hide Arm/Group Description:

Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..

Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors: Oral medications, received 1-2 times per day

Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors: Oral medications, received 1-2 times per day

Overall Number of Participants Analyzed 261 264
Mean (Standard Deviation)
Unit of Measure: mmHg
130.8  (20.7) 135.9  (20.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comprehensive Intervention Group, Less Intensive Intervention Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method General Linear Mixed Model
Comments [Not Specified]
3.Primary Outcome
Title HbA1c
Hide Description Fasting for 12 hour blood sample was measured in standardized lab
Time Frame Measured at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Only the participants with a diagnosis of diabetes were assessed for this outcome measure
Arm/Group Title Comprehensive Intervention Group Less Intensive Intervention Group
Hide Arm/Group Description:

Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..

Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors:Oral medications, received 1-2 times per day

Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors: Oral medications, received 1-2 times per day

Overall Number of Participants Analyzed 104 110
Mean (Standard Deviation)
Unit of Measure: percentage of hemoglobin
8.3  (2.2) 8.2  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comprehensive Intervention Group, Less Intensive Intervention Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method General Linear Mixed Model
Comments [Not Specified]
4.Secondary Outcome
Title Patients' Satisfaction With Care and Health Care Utilization
Hide Description Patient satisfaction with care and healthcare utilization was measured with the Patient Assessment for Chronic Illness Care Scale (PACIC). The scores range from 0-5, with 5 being the most satisfied
Time Frame Measured at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Comprehensive Intervention Group Less Intensive Intervention Group
Hide Arm/Group Description:

Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..

Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors: Oral medications, received 1-2 times per day

Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.

Antiplatelet Agents: Aspirin 81 mg q day

Beta Blocker: Oral medication

ACE Inhibitors: Oral medications, received 1-2 times per day

Overall Number of Participants Analyzed 261 264
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (0.9) 1.8  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comprehensive Intervention Group, Less Intensive Intervention Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method General Linear Mixed Model
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Comprehensive Intervention Group Less Intensive Intervention
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Comprehensive Intervention Group Less Intensive Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Comprehensive Intervention Group Less Intensive Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/261 (0.00%)   0/264 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Comprehensive Intervention Group Less Intensive Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/261 (0.00%)   0/264 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jerilyn Allen
Organization: Johns Hopkins University
Phone: 410-614-4882
EMail: jallen1@jhu.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00241904     History of Changes
Obsolete Identifiers: NCT00385619
Other Study ID Numbers: 335
R01HL082638 ( U.S. NIH Grant/Contract )
First Submitted: October 17, 2005
First Posted: October 19, 2005
Results First Submitted: April 14, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017