Trial Outcomes & Findings for Reducing Total Cardiovascular Risk in an Urban Community (NCT NCT00241904)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

525 participants

Primary outcome timeframe

Measured at 1 year

Results posted on

2017-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Comprehensive Intervention Group 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	Less Intensive Intervention (Usual Care) 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.
Overall Study STARTED	261	264
Overall Study COMPLETED	227	240
Overall Study NOT COMPLETED	34	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Total Cardiovascular Risk in an Urban Community

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comprehensive Intervention n=261 Participants CI intervention will receive Behavioral: Lifestyle Changes, Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercises, as well as pharmacologic agents	Less Intensive Intervention n=264 Participants 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 n=525 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 12 • n=5 Participants	54.7 years STANDARD_DEVIATION 11.5 • n=7 Participants	54.5 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	187 Participants n=5 Participants	187 Participants n=7 Participants	374 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	77 Participants n=7 Participants	151 Participants n=5 Participants
Race/Ethnicity, Customized Black	207 Participants n=5 Participants	210 Participants n=7 Participants	417 Participants n=5 Participants
Race/Ethnicity, Customized White	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at 1 year

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

Outcome measures

Outcome measures
Measure	Comprehensive Intervention Group n=261 Participants 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	Less Intensive Intervention Group n=264 Participants 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
Low-density Lipoprotein Cholesterol	100.1 mg/dL Standard Deviation 39.2	110.6 mg/dL Standard Deviation 36.8

PRIMARY outcome

Timeframe: Measured at 1 year

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

Outcome measures

Outcome measures
Measure	Comprehensive Intervention Group n=261 Participants 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	Less Intensive Intervention Group n=264 Participants 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
Systolic Blood Pressure	130.8 mmHg Standard Deviation 20.7	135.9 mmHg Standard Deviation 20.5

PRIMARY outcome

Timeframe: Measured at 1 year

Population: Only the participants with a diagnosis of diabetes were assessed for this outcome measure

Fasting for 12 hour blood sample was measured in standardized lab

Outcome measures

Outcome measures
Measure	Comprehensive Intervention Group n=104 Participants 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	Less Intensive Intervention Group n=110 Participants 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
HbA1c	8.3 percentage of hemoglobin Standard Deviation 2.2	8.2 percentage of hemoglobin Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Comprehensive Intervention Group n=261 Participants 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	Less Intensive Intervention Group n=264 Participants 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
Patients' Satisfaction With Care and Health Care Utilization	2.9 units on a scale Standard Deviation 0.9	1.8 units on a scale Standard Deviation 1.0

Adverse Events

Comprehensive Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Less Intensive Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jerilyn Allen

Johns Hopkins University

Phone: 410-614-4882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place