Trial Outcomes & Findings for Veteran Peer Coaches Optimizing and Advancing Cardiac Health (NCT NCT02697422)

Last Updated: 2024-08-09

Results Overview

Change in systolic blood pressure (SBP) from baseline to 12-months. Blood pressure readings were obtained using standard procedures with a blood pressure monitor to obtain a mean SBP score of 3 blood pressure measurements. An increased reduction in mean SBP indicates a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

264 participants

Primary outcome timeframe

Baseline to follow-up at 1 year

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Peer Health Coach Intervention Group Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Overall Study STARTED	134	130
Overall Study COMPLETED	108	117
Overall Study NOT COMPLETED	26	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Peer Health Coach Intervention Group Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Overall Study Declined exit survey	9	2
Overall Study Lost to Follow-up	13	8
Overall Study Death	2	1
Overall Study Withdrawal by Subject	0	1
Overall Study Physician Decision	1	1
Overall Study Exit survey data lost	1	0

Baseline Characteristics

Veteran Peer Coaches Optimizing and Advancing Cardiac Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.	Total n=264 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 9.7 • n=5 Participants	60.9 years STANDARD_DEVIATION 9.8 • n=7 Participants	60.6 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	116 Participants n=7 Participants	229 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	67 participants n=5 Participants	56 participants n=7 Participants	123 participants n=5 Participants
Race/Ethnicity, Customized Black, non-Hispanic	37 participants n=5 Participants	36 participants n=7 Participants	73 participants n=5 Participants
Race/Ethnicity, Customized Multiracial	13 participants n=5 Participants	17 participants n=7 Participants	30 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants
Systolic blood pressure	137.1 mmHg STANDARD_DEVIATION 16.4 • n=5 Participants	135.1 mmHg STANDARD_DEVIATION 19.6 • n=7 Participants	136 mmHg STANDARD_DEVIATION 18.0 • n=5 Participants
Diastolic blood pressure	80.9 mmHg STANDARD_DEVIATION 9.6 • n=5 Participants	81.3 mmHg STANDARD_DEVIATION 11.3 • n=7 Participants	81.1 mmHg STANDARD_DEVIATION 10.48 • n=5 Participants
Hypertension Stage Normal (<120/80 mmHg)	13 Participants n=5 Participants	28 Participants n=7 Participants	41 Participants n=5 Participants
Hypertension Stage Elevated (>=120/80 mmHg)	24 Participants n=5 Participants	16 Participants n=7 Participants	40 Participants n=5 Participants
Hypertension Stage Stage 1 (>=130/90 mmHg)	65 Participants n=5 Participants	52 Participants n=7 Participants	117 Participants n=5 Participants
Hypertension Stage Stage 2 (>=140/90 mmHg)	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Framingham risk score	.22 percentage of CVD risk STANDARD_DEVIATION .16 • n=5 Participants	.26 percentage of CVD risk STANDARD_DEVIATION .17 • n=7 Participants	.24 percentage of CVD risk STANDARD_DEVIATION .17 • n=5 Participants
Body Mass Index (BMI)	31.7 kg/m^2 STANDARD_DEVIATION 5.8 • n=5 Participants	31.9 kg/m^2 STANDARD_DEVIATION 6.3 • n=7 Participants	31.8 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants
CVD Risk: BMI category Overweight (BMI>= 25 kg/m2)	125 Participants n=5 Participants	119 Participants n=7 Participants	244 Participants n=5 Participants
CVD Risk: BMI category Obese (BMI>= 30 kg/m2)	73 Participants n=5 Participants	76 Participants n=7 Participants	149 Participants n=5 Participants
CVD Risk: Current Smoker Status	21 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants
CVD Risk: Low density lipoprotein (LDL-c) cholesterol	107.0 mg/dL STANDARD_DEVIATION 38.6 • n=5 Participants	112.4 mg/dL STANDARD_DEVIATION 38.7 • n=7 Participants	109.6 mg/dL STANDARD_DEVIATION 38.7 • n=5 Participants
Health-related quality of life (HRQoL) mental health mental health component summary (MCS)	46.9 units on a scale STANDARD_DEVIATION 11.7 • n=5 Participants	47.4 units on a scale STANDARD_DEVIATION 11.9 • n=7 Participants	47.1 units on a scale STANDARD_DEVIATION 11.8 • n=5 Participants
Health-related quality of life (HRQoL) physical health component summary (PCS)	39.6 units on a scale STANDARD_DEVIATION 10.6 • n=5 Participants	38.9 units on a scale STANDARD_DEVIATION 10.6 • n=7 Participants	39.3 units on a scale STANDARD_DEVIATION 10.5 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to follow-up at 1 year

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Change in Systolic Blood Pressure (SBP)	-3.32 mm Hg Interval -6.88 to 0.23	-0.40 mm Hg Interval -4.2 to 3.39

SECONDARY outcome

Timeframe: Baseline to follow-up at 1 year

Framingham Cardiovascular risk score (FRS) indicates/measures mean risk of a cardiovascular event in the next 10 years (CVD risk). A subscale range of a minimum score of 0% and maximum score of 30% were used to measure a reduction in FRS scores. FRS algorithms include age, total and high-density lipoprotein cholesterol, systolic blood pressure, treatment for hypertension, diabetes, and cigarette smoking. (Risk is considered low if the FRS is less than 10% (indicating a better outcome), moderate if it is between 10% -19%, and high if it is 20% or higher indicating a worse outcome).

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Framingham Cardiovascular Risk Score (FRS)	-0.01 percentage of CVD risk Interval -0.03 to 0.004	-0.01 percentage of CVD risk Interval -0.03 to 0.004

SECONDARY outcome

Timeframe: Baseline to follow-up at 1 year

Body Mass Index (BMI) are measured as an individual cardiovascular risk. Measurements will be initially recorded in height (feet/inches), and weight (pounds/ ounces, which will be converted to weight in kilograms and height in meters. BMI is calculated as kg/m\^2.

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Body Mass Index (BMI)	-0.04 kg/m^2 Interval -0.48 to 0.4	0.10 kg/m^2 Interval -0.3 to 0.5

SECONDARY outcome

Timeframe: Current tobacco use measured at Baseline and Follow up at one year

Current tobacco use was reported as a binary (YES/NO) outcome based on responses from the Behavioral Risk Factor Surveillance System (BRFSS) measured tobacco use. Current cigarette smoking status and tobacco use ("chewing tobacco, snuff or snus") and frequency of use were measured on a three point scale: "Every day" (worse outcome); "Some days", and "Not at all" (better outcome). Current tobacco use included individuals who reported having smoked at least 100 cigarettes in their entire life (Yes or No) and reported smoking cigarettes now ("Every day" or "Some days"). Differences in primary and secondary outcomes between intervention and control groups were calculated using logistic regression.

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Current Tobacco Use	21 Participants	29 Participants

SECONDARY outcome

Timeframe: Baseline to follow-up at 1 year

Low density lipoprotein cholesterol (LDL-c) is measured as mg/dL. Lipoprotein cholesterol will be assessed as an individual cardiovascular risk and is based laboratory data of blood tests from VA CPRS medical records (when taken within 6 months of baseline and/or 1 year follow up appointment). If no lab data exits within this timeframe, blood was drawn.

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Low Density Lipoprotein Cholesterol (LDL-c).	-3.12 mg/dL Interval -8.36 to 2.12	-4.24 mg/dL Interval -9.75 to 1.27

SECONDARY outcome

Timeframe: Baseline to follow-up at 1 year

12-Item Short Form Health Survey (SF-12) Mental Component Summary: Summary scores for vitality, mental health, social functioning, and role-emotional. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning Scaling scores are assessed using published standardized scoring system procedures for the SF-12.

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score	2.19 points Interval 0.26 to 4.12	-1.01 points Interval -2.91 to 0.88

SECONDARY outcome

Timeframe: Baseline to follow-up at 1 year

12-Item Short Form Health Survey (SF-12) Physical Component Summary: Summary scores for general health, physical functioning, role-physical, and bodily pain. Scores range from a minimum score of 0 to a maximum score of 100, with higher scores indicating better physical and mental health functioning Scaling scores are assessed using published standardized scoring system for the SF-12.

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS)	1.02 points on a 0-100 scale Interval -0.73 to 2.77	0.72 points on a 0-100 scale Interval -0.82 to 2.27

SECONDARY outcome

Timeframe: Baseline to follow-up at 1 year

Health care hospitalization utilization are measured using VA administrative data.

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Number of Hospitalizations	0.16 visits Standard Deviation 0.53	0.13 visits Standard Deviation 0.47

SECONDARY outcome

Timeframe: Baseline to follow-up at 1 year

Health care emergency room (ER) utilization are measured using VA administrative data.

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Number of Emergency Room (ER) Visits	0.86 visits Standard Deviation 1.37	0.86 visits Standard Deviation 1.66

SECONDARY outcome

Timeframe: Baseline to follow-up at 1 year

Outpatient clinic/primary care utilization are measured using VA administrative data.

Outcome measures

Outcome measures
Measure	Peer Health Coach Intervention Group n=134 Participants Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors. Community-based peer health coach intervention: The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).	Control Group n=130 Participants Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care.
Number of Outpatient Clinic/Primary Care Visits	0.40 visits Standard Deviation 0.89	0.55 visits Standard Deviation 1.35

Adverse Events

Peer Health Coach Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karin Nelson

VA Puget Sound Health Care System

Phone: (206)277-4507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place