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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL132148 | U.S. NIH Grant/Contract | View source | |
| A534225 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\CARDIOLOGY | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Wake Forest University Health Sciences | OTHER |
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This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.
Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and hypertension control (secondary) after 6 and 12 months, compared to usual clinical care.
Aim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral outcomes) at 6 and 12 months, compared to usual clinical care.
Aim 3. To examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials |
|
| Usual clinical care | No Intervention | Usual care arm participants will receive routine hypertension clinical care per their primary care provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Blood Pressure Monitoring | Behavioral | Intervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Systolic Ambulatory Blood Pressure (mmHg) | 24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months. | baseline, 6 month, and 12 month follow-up |
| 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | 24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months. | baseline, 6 month, and 12 month follow-up |
| Clinic Systolic Blood Pressure (mmHg) | Systolic Blood Pressure measured at baseline, 6 months, and 12 months. | baseline, 6 month, and 12 month follow-up |
| Clinic Diastolic Blood Pressure (mmHg) | Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months. | baseline, 6 month, and 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Achieve Hypertension Control at 6 Months | Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension control will be defined using ambulatory blood pressures as the gold standard (<130/80 mmHg); otherwise a clinic blood pressure of <140/90 mmHg will be used. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health Coach Fidelity to the Study Intervention | Evaluation of health coach fidelity to administering the motivational interviewing intervention per protocol will be assessed every 2 months using a modified Behavior Change Counseling Index | through completion of administering the study intervention, an average of 4 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara Hoppe, DO | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine & Public Health | Madison | Wisconsin | 53792 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30677485 | Background | Johnson HM, Sullivan-Vedder L, Kim K, McBride PE, Smith MA, LaMantia JN, Fink JT, Knutson Sinaise MR, Zeller LM, Lauver DR. Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial. Contemp Clin Trials. 2019 Mar;78:88-100. doi: 10.1016/j.cct.2019.01.010. Epub 2019 Jan 21. | |
| 36735261 | Derived | Hoppe KK, Smith M, Birstler J, Kim K, Sullivan-Vedder L, LaMantia JN, Knutson Sinaise MR, Swenson M, Fink J, Haggart R, McBride P, Lauver DR, Johnson HM. Effect of a Telephone Health Coaching Intervention on Hypertension Control in Young Adults: The MyHEART Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255618. doi: 10.1001/jamanetworkopen.2022.55618. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials Home Blood Pressure Monitoring: Intervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls. Telephone Health Coaching: Intervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls. |
| FG001 | Usual Clinical Care | Usual care arm participants will receive routine hypertension clinical care per their primary care provider. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials. |
| BG001 | Usual Clinical Care | Usual care arm participants will receive routine hypertension clinical care per their primary care provider. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 24-hour Systolic Ambulatory Blood Pressure (mmHg) | 24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Median | Standard Deviation | mmHg | baseline, 6 month, and 12 month follow-up |
|
up to 13 months
Participants were asked about Adverse Events (AE) during all in-person visits and by phone in the follow-up call. Participants in the intervention arm were asked about ER, urgent care, hospitalizations, and blood pressure-related symptoms during health coach calls.
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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 | Intervention | Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders - Other | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Hoppe, DO | University of Wisconsin School of Medicine and Public Health | 608-417-4224 | khoppe2@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2022 | Jan 12, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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|
| Telephone Health Coaching | Behavioral | Intervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls. |
|
| Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | Mean daily sodium intake (milligrams/day) at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment | baseline, 6 month, and 12 month follow-up |
| Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | Mean number of combined fruit and vegetable servings measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in cups equivalent. | baseline, 6 month, and 12 month follow-up |
| Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | Ounces of whole grain measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment | baseline, 6 month, and 12 month follow-up |
| Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | Saturated fat measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in percent kilocalories | baseline, 6 month, and 12 month follow-up |
| Physical Activity as Assessed by the Godin Physical Activity Questionnaire | Mean weekly amounts of physical activity as assessed by the Godin Physical Activity Questionnaire. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. Scoring is calculated as follows (units are times per week that the participant engaged in any of the 3 classifications of activity longer than 15 minutes during their free time):
A minimum score of 0 indicates no activity, a score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active, a theoretical maximum does not exist. | baseline, 6 month, and 12 month follow-up |
| Home Blood Pressure Monitoring Frequency | Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months. | baseline, 6 month, and 12 month follow-up |
| Standing Weight (kg) | Weight (kg) measured at baseline, 6 months, and 12 months. | baseline, 6 month, and 12 month follow-up |
| Perceived Competence as Assessed by the Perceived Competence Scale for Diet | Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence. | baseline, 6 month, and 12 month follow-up |
| Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence. | baseline, 6 month, and 12 month follow-up |
| Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy. | baseline, 6 month, and 12 month follow-up |
| Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy. | baseline, 6 month, and 12 month follow-up |
| Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation. | baseline, 6 month, and 12 month follow-up |
| Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation. | baseline, 6 month, and 12 month follow-up |
| Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation. | baseline, 6 month, and 12 month follow-up |
| Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation. | baseline, 6 month, and 12 month follow-up |
| Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation. | baseline, 6 month, and 12 month follow-up |
| Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation. | baseline, 6 month, and 12 month follow-up |
| Adverse Events |
Number and type of adverse events |
| Through study completion, an average of 5 years |
| Serious Adverse Events | Number and type of serious adverse events | Through study completion, an average of 5 years |
| Withdrawal | Subject Withdrawal Rate | Through study completion, an average of 5 years |
| Aurora Health Care |
| Milwaukee |
| Wisconsin |
| 53233 |
| United States |
| Withdrawal by Subject |
|
| Death |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Alcohol Beverages per week | Median | Full Range | servings of alcohol per week |
|
| Ambulatory Diastolic Blood Pressure (BP) | Median | Full Range | mmHg |
|
| Ambulatory Systolic BP | Median | Full Range | mmHg |
|
| Body Mass Index (BMI) | Median | Full Range | kg/m^2 |
|
| Number of Children at Home | Median | Full Range | children |
|
| Office Diastolic BP | Median | Full Range | mmHg |
|
| Office Systolic BP | Median | Full Range | mmHg |
|
| Waist Circumference | Median | Full Range | centimeters |
|
| Weight | Median | Full Range | kilograms |
|
| Cigarette Tobacco Status | Count of Participants | Participants |
|
| Godin-Shephard Physical Activity | Count of Participants | Participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Number of Antihypertensive Medications | Count of Participants | Participants |
|
| Self-Perceived Health Status | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
| Risk Factors | Count of Participants | Participants |
|
|
|
| Primary | 24-hour Diastolic Ambulatory Blood Pressure (mmHg) | 24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | mmHg | baseline, 6 month, and 12 month follow-up |
|
|
|
| Primary | Clinic Systolic Blood Pressure (mmHg) | Systolic Blood Pressure measured at baseline, 6 months, and 12 months. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Median | Standard Deviation | mmHg | baseline, 6 month, and 12 month follow-up |
|
|
|
| Primary | Clinic Diastolic Blood Pressure (mmHg) | Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | mmHg | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Number of Participants That Achieve Hypertension Control at 6 Months | Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension control will be defined using ambulatory blood pressures as the gold standard (<130/80 mmHg); otherwise a clinic blood pressure of <140/90 mmHg will be used. | participants lost to follow up, withdrew, and/or removed from study per physician, 2 participants in the Usual clinical care arm did not wear their cuff long enough to get adequate readings for AMBP | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| Secondary | Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | Mean daily sodium intake (milligrams/day) at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | milligrams per day | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | Mean number of combined fruit and vegetable servings measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in cups equivalent. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | cups per day | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | Ounces of whole grain measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | ounces per day | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment | Saturated fat measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in percent kilocalories | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | percent kilocalories | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Physical Activity as Assessed by the Godin Physical Activity Questionnaire | Mean weekly amounts of physical activity as assessed by the Godin Physical Activity Questionnaire. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. Scoring is calculated as follows (units are times per week that the participant engaged in any of the 3 classifications of activity longer than 15 minutes during their free time):
A minimum score of 0 indicates no activity, a score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active, a theoretical maximum does not exist. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Home Blood Pressure Monitoring Frequency | Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Count of Participants | Participants | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Standing Weight (kg) | Weight (kg) measured at baseline, 6 months, and 12 months. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | kilograms | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Perceived Competence as Assessed by the Perceived Competence Scale for Diet | Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Perceived Competence as Assessed by the Perceived Competence Scale for Exercise | Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet | Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise | Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet | Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Secondary | Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise | Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation. | participants lost to follow up, withdrew, and/or removed from study per physician | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 month, and 12 month follow-up |
|
|
|
| Other Pre-specified | Health Coach Fidelity to the Study Intervention | Evaluation of health coach fidelity to administering the motivational interviewing intervention per protocol will be assessed every 2 months using a modified Behavior Change Counseling Index | Not Posted | through completion of administering the study intervention, an average of 4 years | Participants |
| Other Pre-specified | Adverse Events | Number and type of adverse events | Not Posted | Through study completion, an average of 5 years | Participants |
| Other Pre-specified | Serious Adverse Events | Number and type of serious adverse events | Not Posted | Through study completion, an average of 5 years | Participants |
| Other Pre-specified | Withdrawal | Subject Withdrawal Rate | Not Posted | Through study completion, an average of 5 years | Participants |
| 0 |
| 157 |
| 3 |
| 157 |
| 56 |
| 157 |
| EG001 | Usual Clinical Care | Usual care arm participants will receive routine hypertension clinical care per their primary care provider. | 1 | 159 | 5 | 159 | 38 | 159 |
| Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vascular disorders - Other | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
|
| Endocrine disorders - Other | Endocrine disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Immune system disorders - Other | Immune system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Infections and infestations - Other | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Nervous system disorders - Other | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Reproductive system and breast disorders - Other | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Social circumstances - Other | Social circumstances | CTCAE v4.0 | Systematic Assessment |
|
| Surgical and medical procedures | CTCAE v4.0 | Systematic Assessment |
|
| Vascular disorders - Other | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Cardiac disorders - Other | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| General disorders and administration site conditions - Other | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
|
| Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
|
| Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Psychiatric disorders - Other | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 6 months |
|
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| 12 months |
|
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| 6 month |
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| 12 month |
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| 6 months |
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| 12 months |
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| Clinic Measured Blood Pressure |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| At least once per month |
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| At least once a week |
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| At least once a day |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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