Cardiovascular Disease (CVD), Hyperlipemia, Hypertension, Obesity
Conditions
Keywords
Smoking (tobacco use), Peer health coach, Systolic blood pressure, Framingham Cardiovascular risk score, Lipid, Health related quality of life, Health care utilization, Medication adherence, Physical activity, Nutrition, Alcohol use, Stress management
Brief summary
The purpose of this study is to test if having a Veteran peer health coach will improve blood pressure control among Veterans with high blood pressure and at least one other Cardiovascular disease (CVD) risk factor. The intervention will deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk, including healthy diet, regular to moderate-intensity physical activity, and smoking cessation. Facilitators, barriers, and costs of the intervention will be determined.
Detailed description
The Vet-COACH study is a peer health coaching program to help reduce Cardiovascular disease (CVD) risk among Veterans. The goal of the study is to test the effectiveness of a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple CVD risk factors with a hybrid type 1 implementation study. The study will focus on Veterans with poorly controlled hypertension and at least one other CVD risk factor to target a high risk population. The study will conduct a randomized controlled trial to enroll n=400 Veterans to compare a peer health coach intervention consisting of home visits, telephone support, and linkages to appropriate community-based and clinic resources compared to usual VHA primary care. The primary outcome is reduction in systolic blood pressure from baseline to follow-up at 1-year. Secondary outcomes include a reduction in Framingham Cardiovascular risk score, individual cardiovascular risks (tobacco use, lipids), health related quality of life, and health care use. The investigators will also assess the effects of the peer health coach intervention on intermediate outcomes including social support, patient activation, patient/provider communication and health behaviors (e.g. medication adherence, physical activity, nutrition, alcohol use, and stress management). The cost of the intervention will be assessed to inform feasibility for future studies, determine Veteran and staff satisfaction with the intervention, and identify barriers and facilitators to adoption. Note, the intermediate outcomes were not prespecified in the protocol for evaluation and were not specified in the grant, protocol paper, or in our SAP as outcomes and were removed from results analysis.
Interventions
OTHERCommunity-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).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
N/A; No masking will occur in this clinical trial.
Intervention model description
Parallel: Participants are assigned to one of two groups--the control or intervention group- in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must be a Veteran * Have \> 1 visit to VA Puget Sound Health Care Center(Seattle or American Lake VA) primary care or women's clinic in the past year * Poorly controlled hypertension (\> 150/90 mmHg) * At least one other CVD risk (including overweight or obesity, body mass index \> 25 kg/m2, tobacco use, hyperlipidemia LDL-c \> 130 mg/dL)
Exclusion criteria
* Hospitalization in the past 3 months for cardiovascular-related conditions (IHD, Cerebral Vascular Accident \[CVA\], PVD) * Severe illness that precludes lifestyle program, end-stage renal disease (ESRD) on dialysis * Nursing home resident, homeless * Severe cognitive impairment * Receiving home-based primary care (including VA Home Tele-Health and patients who received palliative care or are enrolled in hospice care)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | Baseline to follow-up at 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Emergency Room (ER) Visits | Baseline to follow-up at 1 year | Health care emergency room (ER) utilization are measured using VA administrative data. |
| Framingham Cardiovascular Risk Score (FRS) | 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). |
| Body Mass Index (BMI) | 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. |
| Current Tobacco Use | 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. |
| Number of Outpatient Clinic/Primary Care Visits | Baseline to follow-up at 1 year | Outpatient clinic/primary care utilization are measured using VA administrative data. |
| Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score | 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. |
| Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS) | 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. |
| Number of Hospitalizations | Baseline to follow-up at 1 year | Health care hospitalization utilization are measured using VA administrative data. |
| Low Density Lipoprotein Cholesterol (LDL-c). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 134 |
| 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. | 130 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Declined exit survey | 9 | 2 |
| Overall Study | Exit survey data lost | 1 | 0 |
| Overall Study | Lost to Follow-up | 13 | 8 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control Group | Peer Health Coach Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 9.8 | 60.3 years STANDARD_DEVIATION 9.7 | 60.6 years STANDARD_DEVIATION 9.7 |
| Body Mass Index (BMI) | 31.9 kg/m^2 STANDARD_DEVIATION 6.3 | 31.7 kg/m^2 STANDARD_DEVIATION 5.8 | 31.8 kg/m^2 STANDARD_DEVIATION 6.1 |
| CVD Risk: BMI category Obese (BMI>= 30 kg/m2) | 76 Participants | 73 Participants | 149 Participants |
| CVD Risk: BMI category Overweight (BMI>= 25 kg/m2) | 119 Participants | 125 Participants | 244 Participants |
| CVD Risk: Current Smoker Status | 29 Participants | 21 Participants | 50 Participants |
| CVD Risk: Low density lipoprotein (LDL-c) cholesterol | 112.4 mg/dL STANDARD_DEVIATION 38.7 | 107.0 mg/dL STANDARD_DEVIATION 38.6 | 109.6 mg/dL STANDARD_DEVIATION 38.7 |
| Diastolic blood pressure | 81.3 mmHg STANDARD_DEVIATION 11.3 | 80.9 mmHg STANDARD_DEVIATION 9.6 | 81.1 mmHg STANDARD_DEVIATION 10.48 |
| Framingham risk score | .26 percentage of CVD risk STANDARD_DEVIATION 0.17 | .22 percentage of CVD risk STANDARD_DEVIATION 0.16 | .24 percentage of CVD risk STANDARD_DEVIATION 0.17 |
| Health-related quality of life (HRQoL) mental health mental health component summary (MCS) | 47.4 units on a scale STANDARD_DEVIATION 11.9 | 46.9 units on a scale STANDARD_DEVIATION 11.7 | 47.1 units on a scale STANDARD_DEVIATION 11.8 |
| Health-related quality of life (HRQoL) physical health component summary (PCS) | 38.9 units on a scale STANDARD_DEVIATION 10.6 | 39.6 units on a scale STANDARD_DEVIATION 10.6 | 39.3 units on a scale STANDARD_DEVIATION 10.5 |
| Hypertension Stage Elevated (>=120/80 mmHg) | 16 Participants | 24 Participants | 40 Participants |
| Hypertension Stage Normal (<120/80 mmHg) | 28 Participants | 13 Participants | 41 Participants |
| Hypertension Stage Stage 1 (>=130/90 mmHg) | 52 Participants | 65 Participants | 117 Participants |
| Hypertension Stage Stage 2 (>=140/90 mmHg) | 34 Participants | 32 Participants | 66 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 36 participants | 37 participants | 73 participants |
| Race/Ethnicity, Customized Hispanic | 10 participants | 7 participants | 17 participants |
| Race/Ethnicity, Customized Multiracial | 17 participants | 13 participants | 30 participants |
| Race/Ethnicity, Customized White, non-Hispanic | 56 participants | 67 participants | 123 participants |
| Sex: Female, Male Female | 14 Participants | 21 Participants | 35 Participants |
| Sex: Female, Male Male | 116 Participants | 113 Participants | 229 Participants |
| Systolic blood pressure | 135.1 mmHg STANDARD_DEVIATION 19.6 | 137.1 mmHg STANDARD_DEVIATION 16.4 | 136 mmHg STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 134 | 1 / 130 |
| other Total, other adverse events | 0 / 134 | 0 / 130 |
| serious Total, serious adverse events | 0 / 134 | 0 / 130 |
Outcome results
Primary
Change in Systolic Blood Pressure (SBP)
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.
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peer Health Coach Intervention Group | Change in Systolic Blood Pressure (SBP) | -3.32 mm Hg |
| Control Group | Change in Systolic Blood Pressure (SBP) | -0.40 mm Hg |
p-value: 0.05Regression, Linear
Secondary
Body Mass Index (BMI)
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.
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peer Health Coach Intervention Group | Body Mass Index (BMI) | -0.04 kg/m^2 |
| Control Group | Body Mass Index (BMI) | 0.10 kg/m^2 |
p-value: 0.05Regression, Linear
Secondary
Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score
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.
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peer Health Coach Intervention Group | Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score | 2.19 points |
| Control Group | Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score | -1.01 points |
p-value: 0.05Regression, Linear
Secondary
Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS)
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.
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peer Health Coach Intervention Group | Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS) | 1.02 points on a 0-100 scale |
| Control Group | Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS) | 0.72 points on a 0-100 scale |
p-value: 0.05Regression, Linear
Secondary
Current Tobacco Use
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.
Time frame: Current tobacco use measured at Baseline and Follow up at one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer Health Coach Intervention Group | Current Tobacco Use | 21 Participants |
| Control Group | Current Tobacco Use | 29 Participants |
Comparison: Smoker/tobacco use results were calculated using logistic regression. A P value of .90 was found comparing smoking/tobacco use in intervention vs control participants. A difference was not reported between intervention and control because smoking/ tobacco use was a binary variable.p-value: 0.9Regression, Logistic
Secondary
Framingham Cardiovascular Risk Score (FRS)
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).
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peer Health Coach Intervention Group | Framingham Cardiovascular Risk Score (FRS) | -0.01 percentage of CVD risk |
| Control Group | Framingham Cardiovascular Risk Score (FRS) | -0.01 percentage of CVD risk |
p-value: 0.05Regression, Linear
Secondary
Low Density Lipoprotein Cholesterol (LDL-c).
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.
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peer Health Coach Intervention Group | Low Density Lipoprotein Cholesterol (LDL-c). | -3.12 mg/dL |
| Control Group | Low Density Lipoprotein Cholesterol (LDL-c). | -4.24 mg/dL |
p-value: 0.05Regression, Linear
Secondary
Number of Emergency Room (ER) Visits
Health care emergency room (ER) utilization are measured using VA administrative data.
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Health Coach Intervention Group | Number of Emergency Room (ER) Visits | 0.86 visits | Standard Deviation 1.37 |
| Control Group | Number of Emergency Room (ER) Visits | 0.86 visits | Standard Deviation 1.66 |
p-value: 0.05Regression, Linear
Secondary
Number of Hospitalizations
Health care hospitalization utilization are measured using VA administrative data.
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Health Coach Intervention Group | Number of Hospitalizations | 0.16 visits | Standard Deviation 0.53 |
| Control Group | Number of Hospitalizations | 0.13 visits | Standard Deviation 0.47 |
p-value: 0.05Regression, Linear
Secondary
Number of Outpatient Clinic/Primary Care Visits
Outpatient clinic/primary care utilization are measured using VA administrative data.
Time frame: Baseline to follow-up at 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Health Coach Intervention Group | Number of Outpatient Clinic/Primary Care Visits | 0.40 visits | Standard Deviation 0.89 |
| Control Group | Number of Outpatient Clinic/Primary Care Visits | 0.55 visits | Standard Deviation 1.35 |
p-value: 0.05Regression, Linear