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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer health coach intervention group | Experimental | 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. |
|
| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-based peer health coach intervention | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to follow-up at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin M. Nelson, MD MSHS | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30172037 | Result | Nelson K, Fennell T, Gray KE, Williams JL, Lutton MC, Silverman J, Jain K, Augustine MR, Kopf W, Taylor L, Sayre G, Vanderwarker C. Veteran peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH); design and rationale for a randomized controlled trial of peer support among Veterans with poorly controlled hypertension and other CVD risks. Contemp Clin Trials. 2018 Oct;73:61-67. doi: 10.1016/j.cct.2018.08.011. Epub 2018 Aug 29. | |
| 37278999 |
| Label | URL |
|---|---|
| published standardized scoring system for the SF-12 | View source |
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We will adhere to all VA 1200.12 policies to protect individual privacy & confidentiality of data. Data will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted & evaluated by the VA Puget Sound FOIA Officer, or as passed down to the facility.
A unique study ID will label all data records to allow validation of results, but prevent data from being linked to individuals. Records across data sets can be cross-referenced using the study ID to verify accuracy of publication results. Research publications will be made available to the public via the National Library of Medicine PubMed Central website within one year after publication date(s). A Limited Dataset will be created & shared pursuant a Data Use Agreement that appropriately limits use of the dataset & prohibits recipients from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline to follow-up at 1 year |
|
Baseline to follow up at 1 year
Study intervention posed minimal risk to all participants. Deaths were assessed and determined to be unrelated to the study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karin Nelson | VA Puget Sound Health Care System | (206)277-4507 | karin.nelson@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2020 | Jan 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2023 | Nov 24, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D009765 | Obesity |
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D010342 | Patient Acceptance of Health Care |
| D055118 | Medication Adherence |
| D009043 | Motor Activity |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Parallel: Participants are assigned to one of two groups--the control or intervention group- in parallel for the duration of the study.
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N/A; No masking will occur in this clinical trial.
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|
|
| Baseline to follow-up at 1 year |
| 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. | Baseline to follow-up at 1 year |
| 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. | Current tobacco use measured at Baseline and Follow up at one year |
| 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. | Baseline to follow-up at 1 year |
| 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. | Baseline to follow-up at 1 year |
| 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. | Baseline to follow-up at 1 year |
| Number of Hospitalizations | Health care hospitalization utilization are measured using VA administrative data. | Baseline to follow-up at 1 year |
| Number of Emergency Room (ER) Visits | Health care emergency room (ER) utilization are measured using VA administrative data. | Baseline to follow-up at 1 year |
| Number of Outpatient Clinic/Primary Care Visits | Outpatient clinic/primary care utilization are measured using VA administrative data. | Baseline to follow-up at 1 year |
| Result |
| Nelson KM, Taylor L, Williams JL, Rao M, Gray KE, Kramer CB, Epler E, Fennell T. Effect of a Peer Health Coaching Intervention on Clinical Outcomes Among US Veterans With Cardiovascular Risks: The Vet-COACH Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317046. doi: 10.1001/jamanetworkopen.2023.17046. |
| 39415799 | Derived | Kramer CB, Nelson KM, Sayre G, Williams JL, Spruill L, Fennell T, Gray KE, Weiner BJ, Fan V, Jones-Smith J, Rao M. "Veteran to Veteran, There's Automatically a Trust": A Qualitative Study of Veterans' Experiences in a Peer Health-Coaching Program for Hypertension. AJPM Focus. 2024 Jul 3;3(6):100257. doi: 10.1016/j.focus.2024.100257. eCollection 2024 Dec. |
| Death |
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| Withdrawal by Subject |
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| Physician Decision |
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| Exit survey data lost |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Hypertension Stage | Count of Participants | Participants |
|
| Framingham risk score | FRS score is determined according to FRS algorithms, which 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. | Mean | Standard Deviation | percentage of CVD risk |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| CVD Risk: BMI category | Count of Participants | Participants |
|
| CVD Risk: Current Smoker Status | Count of Participants | Participants |
|
| CVD Risk: Low density lipoprotein (LDL-c) cholesterol | Mean | Standard Deviation | mg/dL |
|
| Health-related quality of life (HRQoL) mental health mental health component summary (MCS) | Health-related quality of life is measured by the Medical Outcomes Study 12-item measure (SF-12). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. | Mean | Standard Deviation | units on a scale |
|
| Health-related quality of life (HRQoL) physical health component summary (PCS) | Health-related quality of life is measured by the Medical Outcomes Study 12-item measure (SF-12). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| 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). | Posted | Mean | 95% Confidence Interval | percentage of CVD risk | Baseline to follow-up at 1 year |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | kg/m^2 | Baseline to follow-up at 1 year |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Current tobacco use measured at Baseline and Follow up at one year |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline to follow-up at 1 year |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | points | Baseline to follow-up at 1 year |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | points on a 0-100 scale | Baseline to follow-up at 1 year |
|
|
|
|
| Secondary | Number of Hospitalizations | Health care hospitalization utilization are measured using VA administrative data. | Posted | Mean | Standard Deviation | visits | Baseline to follow-up at 1 year |
|
|
|
|
| Secondary | Number of Emergency Room (ER) Visits | Health care emergency room (ER) utilization are measured using VA administrative data. | Posted | Mean | Standard Deviation | visits | Baseline to follow-up at 1 year |
|
|
|
|
| Secondary | Number of Outpatient Clinic/Primary Care Visits | Outpatient clinic/primary care utilization are measured using VA administrative data. | Posted | Mean | Standard Deviation | visits | Baseline to follow-up at 1 year |
|
|
|
|
| 2 |
| 134 |
| 0 |
| 134 |
| 0 |
| 134 |
| EG001 | 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. | 1 | 130 | 0 | 130 | 0 | 130 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D010349 | Patient Compliance |
| D004327 | Drinking Behavior |