COACH: Reducing Total Cardiovascular Risk in an Urban Community

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00241904
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 525
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON FAMILY HEALTH CENTER.

The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Heart Diseases; Coronary Disease; Diabetes Mellitus; Atherosclerosis; Cerebral Arteriosclerosis; Hypertension	Behavioral: Lifestyle Changes; Drug: Antiplatelet Agents; Drug: Beta Blocker; Drug: ACE Inhibitors	Phase 4

Detailed Description

BACKGROUND:

The study is based on the premise that a community-based participatory research partnership model, using a team of an advanced practice nurse case manager, community health worker (CHW), and physician can be translated into urban community clinics and improve the quality of care and reduce disparities in cardiovascular health in minority and other underserved populations. Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of CVD risk-reducing practices remains poor. In spite of the known benefit of lowering low-density lipoprotein cholesterol (LDL-C) levels below 100 mg/dl in persons with existing heart disease, as many as 50 to 70 percent of eligible CVD patients are not placed on lipid-lowering therapy by their providers and from 20 to 80 percent of patients do not achieve the goals of therapy. The benefits of controlling high blood pressure (HBP) are well established, yet national rates of HBP control remain at only 31 percent despite decades of provider and patient education. In addition, it is well established that control of glycemia, hyperlipidemia, and blood pressure reduce the risk of vascular complications in people with diabetes, 75 percent of whom die from some form of heart or blood vessel disease. This randomized trial will compare the clinical effectiveness and cost effectiveness of a CI intervention with a LI intervention in African American, and white low-income patients with known excessive CVD risk.

DESIGN NARRATIVE:

Eligible patients with CVD or type 2 diabetes will be randomly selected from two urban federally funded community clinics and randomly assigned to receive either 1) a Cl intervention delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes and medication adherence as well as the prescription and titration of medications or 2) a LI intervention providing feedback on CVD risk factors and guidelines to patients and their physicians. Outcomes will be measured at baseline and one and two years. It is hypothesized that a higher proportion of patients in the Cl intervention group will achieve the treatment goals for lipid, blood pressure, and diabetes management, lifestyle behaviors and utilization of antiplatelet agent, beta blocker, and angiotensin converting enzyme (ACE) inhibitor therapies and that the Cl intervention will be cost-effective. Secondary outcomes include assessment of the impact of the Cl intervention model on patients' satisfaction with care and health care utilization. The increase in the percentage of high-risk women and men who receive recommended secondary prevention therapies and achieve goal levels could potentially result in a marked decrement in annual CVD mortality and health disparities if applied within primary care settings to populations with the characteristics of the target groups for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 525 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Reducing Total Cardiovascular Risk in an Urban Community
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Comprehensive Intervention Group The NP/CHW intervention focused on behavioral interventions to affect therapeutic lifestyle changes and adherence to medications and appointments as well as the prescription and titration of medications for one year. The NP and CHW worked as a team. The NP oversaw the initial assessment and, in collaboration with the CHW, tailored the intervention plan, conducted the intervention including lifestyle modification counseling and medication titration and prescription, consulted with the physician, and supervised the CHW. Specific algorithms for drug treatment of hyperlipidemia, hypertension (HBP), hyperglycemia, ACE, and β-blocker therapy were developed for this study based on current guidelines and standards of care.	Behavioral: Lifestyle Changes; Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise; Drug: Antiplatelet Agents; Aspirin 81 mg q day; Other Names: Bayer, Ecotrin ; Drug: Beta Blocker; Oral medication; Other Names: Metoprolol Toprol Atenolol Propranolol ; Drug: ACE Inhibitors; Oral medications, received 1-2 times per day; Other Names: Lisinopril
Active Comparator: Less Intensive Intervention Group 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. Patients and their providers in the received the results of baseline lipids, BP, and HbA1c along with the recommended goal levels and a pamphlet on controlling risk factors published by the American Heart Association. In addition, providers received copies of the AHA/ACC Guidelines for Secondary Prevention.	Behavioral: Lifestyle Changes; Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Outcome Measures

Primary Outcome Measures

1. Low-density Lipoprotein Cholesterol [Measured at 1 year]

   Blood was drawn after a 12 hour fast and low density lipoprotein cholesterol was measured in a standardized lab

2. Systolic Blood Pressure [Measured at 1 year]

   Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association.

3. HbA1c [Measured at 1 year]

   Fasting for 12 hour blood sample was measured in standardized lab

Secondary Outcome Measures

1. Patients' Satisfaction With Care and Health Care Utilization [Measured at 1 year]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Currently receiving medical care at Johns Hopkins University

• African American or Caucasian and have diagnosed CVD, defined as a prior myocardial infarction, revascularization procedure for coronary disease, ischemic heart disease, stroke, or have diagnosed type 2 diabetes and not receiving any therapy

• Have either no LDL-C in their medical record during the 12 months prior to study entry or have an LDL greater than or equal to 100 mg/dl on or off lipid lowering pharmacotherapy

• Have either no blood pressure recorded in their medical record during the 12 months prior to study entry or a BP greater than 140/90 mmHg or greater than 130/80 mmHg if the participant is diabetic or has renal insufficiency

• If the participant is diabetic he or she has to either have no HbA1c recorded during the 12 months prior to study entry or HbA1c of 7 percent or greater

Exclusion criteria:

• A serious life-threatening noncardiac comorbidity with a life expectancy of less than 5 years

• A serious physician-recorded psychiatric morbidity that would interfere with the study

• Sufficient neurological impairment that would interfere with the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Johns Hopkins University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Jerilyn Allen, Johns Hopkins University School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00241904
• Other Study ID Numbers: 335; R01HL082638; NCT00385619
• First Posted: Oct 19, 2005
• Last Update Posted: Sep 15, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intracranial Arteriosclerosis; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Arteriosclerosis; Propranolol; Metoprolol; Atenolol; Lisinopril; Platelet Aggregation Inhibitors; Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors

Study Results

Participant Flow

Arm/Group Title	Comprehensive Intervention Group	Less Intensive Intervention (Usual Care) Group
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

Baseline Characteristics

Arm/Group Title	Comprehensive Intervention	Less Intensive Intervention	Total
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 Participants	261	264	525
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.3 (12)	54.7 (11.5)	54.5 (11.7)
Sex: Female, Male (Count of Participants)
Female	187 71.6%	187 70.8%	374 71.2%
Male	74 28.4%	77 29.2%	151 28.8%
Race/Ethnicity, Customized (Count of Participants)
Black	207 79.3%	210 79.5%	417 79.4%
White	54 20.7%	54 20.5%	108 20.6%

Outcome Measures

1. Primary Outcome

Title	Low-density Lipoprotein Cholesterol
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comprehensive Intervention Group	Less Intensive Intervention Group
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
Measure Participants	261	264
Mean (Standard Deviation) [mg/dL]	100.1 (39.2)	110.6 (36.8)

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	General Linear Mixed Model
	Comments

2. Primary Outcome

Title	Systolic Blood Pressure
Description	Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association.
Time Frame	Measured at 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comprehensive Intervention Group	Less Intensive Intervention Group
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
Measure Participants	261	264
Mean (Standard Deviation) [mmHg]	130.8 (20.7)	135.9 (20.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comprehensive Intervention Group, Less Intensive Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	General Linear Mixed Model
	Comments

3. Primary Outcome

Title	HbA1c
Description	Fasting for 12 hour blood sample was measured in standardized lab
Time Frame	Measured at 1 year

Outcome Measure Data

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
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
Measure Participants	104	110
Mean (Standard Deviation) [percentage of hemoglobin]	8.3 (2.2)	8.2 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comprehensive Intervention Group, Less Intensive Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments
	Method	General Linear Mixed Model
	Comments

4. Secondary Outcome

Title	Patients' Satisfaction With Care and Health Care Utilization
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comprehensive Intervention Group	Less Intensive Intervention Group
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
Measure Participants	261	264
Mean (Standard Deviation) [units on a scale]	2.9 (0.9)	1.8 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comprehensive Intervention Group, Less Intensive Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	General Linear Mixed Model
	Comments

Adverse Events

Arm/Group Title	Comprehensive Intervention Group		Less Intensive Intervention
Arm/Group Description
All Cause Mortality
	Comprehensive Intervention Group		Less Intensive Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Comprehensive Intervention Group		Less Intensive Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/261 (0%)		0/264 (0%)
Other (Not Including Serious) Adverse Events
	Comprehensive Intervention Group		Less Intensive Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/261 (0%)		0/264 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.