Trial Outcomes & Findings for Young Adult Hypertension Self-Management Clinical Trial (NCT NCT03158051)

NCT ID: NCT03158051

Last Updated: 2023-05-17

Results Overview

24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.

Recruitment status

COMPLETED

Study phase

Target enrollment

316 participants

Primary outcome timeframe

baseline, 6 month, and 12 month follow-up

Results posted on

2023-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Usual Clinical Care Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Overall Study STARTED	157	159
Overall Study Visit 3	100	104
Overall Study Visit 4	100	104
Overall Study Visit 5	86	90
Overall Study Visit 6	86	89
Overall Study COMPLETED	86	89
Overall Study NOT COMPLETED	71	70

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Usual Clinical Care Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Overall Study Lost to Follow-up	41	47
Overall Study Physician Decision	6	7
Overall Study Withdrawal by Subject	24	15
Overall Study Death	0	1

Baseline Characteristics

Young Adult Hypertension Self-Management Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.	Total n=316 Participants Total of all reporting groups
Age, Continuous	33.8 years n=5 Participants	33.7 years n=7 Participants	33.8 years n=5 Participants
Sex/Gender, Customized Female	71 Participants n=5 Participants	74 Participants n=7 Participants	145 Participants n=5 Participants
Sex/Gender, Customized Male	81 Participants n=5 Participants	85 Participants n=7 Participants	166 Participants n=5 Participants
Sex/Gender, Customized Unknown	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Race/Ethnicity, Customized Other	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized White	107 Participants n=5 Participants	115 Participants n=7 Participants	222 Participants n=5 Participants
Region of Enrollment United States	157 participants n=5 Participants	159 participants n=7 Participants	316 participants n=5 Participants
Alcohol Beverages per week	5.3 servings of alcohol per week n=5 Participants	5.1 servings of alcohol per week n=7 Participants	5.2 servings of alcohol per week n=5 Participants
Ambulatory Diastolic Blood Pressure (BP)	86.5 mmHg n=5 Participants	87.0 mmHg n=7 Participants	86.7 mmHg n=5 Participants
Ambulatory Systolic BP	132.6 mmHg n=5 Participants	133.0 mmHg n=7 Participants	132.8 mmHg n=5 Participants
Body Mass Index (BMI)	34.5 kg/m^2 n=5 Participants	34.5 kg/m^2 n=7 Participants	34.5 kg/m^2 n=5 Participants
Number of Children at Home	1.1 children n=5 Participants	1.0 children n=7 Participants	1.0 children n=5 Participants
Office Diastolic BP	90.8 mmHg n=5 Participants	91.8 mmHg n=7 Participants	91.3 mmHg n=5 Participants
Office Systolic BP	138.3 mmHg n=5 Participants	138.0 mmHg n=7 Participants	138.1 mmHg n=5 Participants
Waist Circumference	109.5 centimeters n=5 Participants	109.4 centimeters n=7 Participants	109.4 centimeters n=5 Participants
Weight	103.1 kilograms n=5 Participants	103.3 kilograms n=7 Participants	103.2 kilograms n=5 Participants
Cigarette Tobacco Status Currently Smoke Cigarettes	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Cigarette Tobacco Status Have Never Smoked Cigarettes	97 Participants n=5 Participants	115 Participants n=7 Participants	212 Participants n=5 Participants
Cigarette Tobacco Status Used to Smoke Cigarettes	34 Participants n=5 Participants	25 Participants n=7 Participants	59 Participants n=5 Participants
Cigarette Tobacco Status Unknown	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Godin-Shephard Physical Activity Active	68 Participants n=5 Participants	81 Participants n=7 Participants	149 Participants n=5 Participants
Godin-Shephard Physical Activity Insufficiently Active	84 Participants n=5 Participants	78 Participants n=7 Participants	162 Participants n=5 Participants
Godin-Shephard Physical Activity Unknown	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Highest Level of Education I have not finished High School	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Highest Level of Education I have completed High School	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Highest Level of Education I have not finished College or Vocational School	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Highest Level of Education I have finished College or Vocational School	63 Participants n=5 Participants	74 Participants n=7 Participants	137 Participants n=5 Participants
Highest Level of Education Some / Completed Graduate of Professional School	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Highest Level of Education Unknown	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Marital Status Single	50 Participants n=5 Participants	54 Participants n=7 Participants	104 Participants n=5 Participants
Marital Status Married / Partnered	99 Participants n=5 Participants	101 Participants n=7 Participants	200 Participants n=5 Participants
Marital Status Divorced / Widower	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Marital Status Unknown	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Number of Antihypertensive Medications 0	84 Participants n=5 Participants	78 Participants n=7 Participants	162 Participants n=5 Participants
Number of Antihypertensive Medications 1	46 Participants n=5 Participants	51 Participants n=7 Participants	97 Participants n=5 Participants
Number of Antihypertensive Medications 2	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Number of Antihypertensive Medications 3	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Number of Antihypertensive Medications greater than or equal to 4	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Self-Perceived Health Status Excellent	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Self-Perceived Health Status Very Good or Good	70 Participants n=5 Participants	83 Participants n=7 Participants	153 Participants n=5 Participants
Self-Perceived Health Status Fair	61 Participants n=5 Participants	50 Participants n=7 Participants	111 Participants n=5 Participants
Self-Perceived Health Status Poor or No Response	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Self-Perceived Health Status Unknown	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Comorbidities Anxiety and / or Depression	82 Participants n=5 Participants	78 Participants n=7 Participants	160 Participants n=5 Participants
Comorbidities Chronic Kidney Disease	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Comorbidities Diabetes	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Comorbidities Dyslipidemia	41 Participants n=5 Participants	32 Participants n=7 Participants	73 Participants n=5 Participants
Comorbidities Other Chronic Comorbidity	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants
Risk Factors E-Cigarette / Vaping Use in the past 6 months	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Risk Factors Ever Been on Medicaid	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Risk Factors Family History of Heart Disease or Stroke	52 Participants n=5 Participants	61 Participants n=7 Participants	113 Participants n=5 Participants
Risk Factors Financial Status: Inadequate Income	126 Participants n=5 Participants	122 Participants n=7 Participants	248 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
24-hour Systolic Ambulatory Blood Pressure (mmHg) baseline	132.59 mmHg Standard Deviation 11.36	133.01 mmHg Standard Deviation 12.67
24-hour Systolic Ambulatory Blood Pressure (mmHg) 6 month	128.14 mmHg Standard Deviation 11.36	130.69 mmHg Standard Deviation 13.99
24-hour Systolic Ambulatory Blood Pressure (mmHg) 12 month	128.54 mmHg Standard Deviation 11.95	129.47 mmHg Standard Deviation 14.71

PRIMARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
24-hour Diastolic Ambulatory Blood Pressure (mmHg) 12 months	85.34 mmHg Standard Deviation 9.32	85.52 mmHg Standard Deviation 9.43
24-hour Diastolic Ambulatory Blood Pressure (mmHg) baseline	86.45 mmHg Standard Deviation 7.76	87.04 mmHg Standard Deviation 8.16
24-hour Diastolic Ambulatory Blood Pressure (mmHg) 6 months	84.61 mmHg Standard Deviation 8.24	85.89 mmHg Standard Deviation 9.19

PRIMARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Systolic Blood Pressure measured at baseline, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Clinic Systolic Blood Pressure (mmHg) baseline	138.30 mmHg Standard Deviation 14.27	137.97 mmHg Standard Deviation 14.33
Clinic Systolic Blood Pressure (mmHg) 6 month	130.84 mmHg Standard Deviation 12.16	132.50 mmHg Standard Deviation 15.83
Clinic Systolic Blood Pressure (mmHg) 12 month	131.16 mmHg Standard Deviation 12.77	130.7 mmHg Standard Deviation 15.22

PRIMARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Clinic Diastolic Blood Pressure (mmHg) 12 months	85.05 mmHg Standard Deviation 10.56	85.15 mmHg Standard Deviation 12.31
Clinic Diastolic Blood Pressure (mmHg) baseline	90.81 mmHg Standard Deviation 11.42	91.77 mmHg Standard Deviation 11.26
Clinic Diastolic Blood Pressure (mmHg) 6 months	83.83 mmHg Standard Deviation 9.36	86.70 mmHg Standard Deviation 12.44

SECONDARY outcome

Timeframe: up to 6 months

Population: 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

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.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Number of Participants That Achieve Hypertension Control at 6 Months 24-hour Ambulatory Blood Pressure	20 Participants	21 Participants
Number of Participants That Achieve Hypertension Control at 6 Months Clinic Measured Blood Pressure	60 Participants	60 Participants

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment baseline	3512.82 milligrams per day Standard Deviation 1765.59	3672.81 milligrams per day Standard Deviation 1812.82
Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment 6 months	3354.72 milligrams per day Standard Deviation 1365.75	3968.20 milligrams per day Standard Deviation 1725.17
Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment 12 months	3682.94 milligrams per day Standard Deviation 1874.53	4213.67 milligrams per day Standard Deviation 1972.37

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment baseline	2.34 cups per day Standard Deviation 2.02	2.50 cups per day Standard Deviation 1.98
Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment 6 months	2.43 cups per day Standard Deviation 1.75	2.57 cups per day Standard Deviation 1.89
Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment 12 months	2.50 cups per day Standard Deviation 1.92	2.55 cups per day Standard Deviation 1.88

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment baseline	0.61 ounces per day Standard Deviation 1.05	0.85 ounces per day Standard Deviation 1.41
Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment 6 months	0.88 ounces per day Standard Deviation 1.49	1.12 ounces per day Standard Deviation 1.62
Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment 12 months	0.82 ounces per day Standard Deviation 1.25	1.14 ounces per day Standard Deviation 2.24

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment baseline	11.91 percent kilocalories Standard Deviation 4.19	12.54 percent kilocalories Standard Deviation 4.32
Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment 6 months	12.97 percent kilocalories Standard Deviation 4.62	13.12 percent kilocalories Standard Deviation 6.56
Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment 12 months	12.03 percent kilocalories Standard Deviation 4.72	13.46 percent kilocalories Standard Deviation 4.52

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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): * 9 x strenous units reported + 5 x moderate units reported + 3 x light units reported = score 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.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Physical Activity as Assessed by the Godin Physical Activity Questionnaire baseline	38.24 score on a scale Standard Deviation 31.51	37.24 score on a scale Standard Deviation 26.99
Physical Activity as Assessed by the Godin Physical Activity Questionnaire 6 months	54.47 score on a scale Standard Deviation 61.99	40.69 score on a scale Standard Deviation 31.80
Physical Activity as Assessed by the Godin Physical Activity Questionnaire 12 months	46.67 score on a scale Standard Deviation 46.10	39.22 score on a scale Standard Deviation 25.22

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Home Blood Pressure Monitoring Frequency Baseline · Not on a regular basis	109 Participants	118 Participants
Home Blood Pressure Monitoring Frequency Baseline · At least once per month	23 Participants	20 Participants
Home Blood Pressure Monitoring Frequency 12 months · At least once a day	4 Participants	4 Participants
Home Blood Pressure Monitoring Frequency Baseline · At least once a week	13 Participants	17 Participants
Home Blood Pressure Monitoring Frequency Baseline · At least once a day	7 Participants	4 Participants
Home Blood Pressure Monitoring Frequency 6 months · Not on a regular basis	14 Participants	67 Participants
Home Blood Pressure Monitoring Frequency 6 months · At least once per month	9 Participants	22 Participants
Home Blood Pressure Monitoring Frequency 6 months · At least once a week	64 Participants	10 Participants
Home Blood Pressure Monitoring Frequency 6 months · At least once a day	13 Participants	5 Participants
Home Blood Pressure Monitoring Frequency 12 months · Not on a regular basis	32 Participants	67 Participants
Home Blood Pressure Monitoring Frequency 12 months · At least once per month	20 Participants	11 Participants
Home Blood Pressure Monitoring Frequency 12 months · At least once a week	30 Participants	8 Participants

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Weight (kg) measured at baseline, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Standing Weight (kg) 12 months	97.91 kilograms Standard Deviation 26.07	103.45 kilograms Standard Deviation 25.49
Standing Weight (kg) baseline	102.86 kilograms Standard Deviation 28.64	102.93 kilograms Standard Deviation 27.30
Standing Weight (kg) 6 months	98.54 kilograms Standard Deviation 26.19	103.80 kilograms Standard Deviation 25.34

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Perceived Competence as Assessed by the Perceived Competence Scale for Diet Baseline	4.54 score on a scale Standard Deviation 1.34	4.56 score on a scale Standard Deviation 1.30
Perceived Competence as Assessed by the Perceived Competence Scale for Diet 6 months	5.04 score on a scale Standard Deviation 1.24	4.63 score on a scale Standard Deviation 1.43
Perceived Competence as Assessed by the Perceived Competence Scale for Diet 12 months	4.71 score on a scale Standard Deviation 1.25	4.70 score on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Perceived Competence as Assessed by the Perceived Competence Scale for Exercise 12 months	4.98 score on a scale Standard Deviation 1.47	4.89 score on a scale Standard Deviation 1.49
Perceived Competence as Assessed by the Perceived Competence Scale for Exercise Baseline	4.83 score on a scale Standard Deviation 1.45	5.03 score on a scale Standard Deviation 1.46
Perceived Competence as Assessed by the Perceived Competence Scale for Exercise 6 months	5.28 score on a scale Standard Deviation 1.37	5.01 score on a scale Standard Deviation 1.54

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet baseline	4.63 score on a scale Standard Deviation 1.60	4.93 score on a scale Standard Deviation 1.58
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet 6 months	5.35 score on a scale Standard Deviation 1.41	5.17 score on a scale Standard Deviation 1.48
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet 12 months	5.06 score on a scale Standard Deviation 1.52	5.22 score on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise baseline	4.72 score on a scale Standard Deviation 1.65	5.00 score on a scale Standard Deviation 1.53
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise 6 months	5.31 score on a scale Standard Deviation 1.38	5.17 score on a scale Standard Deviation 1.50
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise 12 months	5.11 score on a scale Standard Deviation 1.57	5.31 score on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet baseline	5.80 score on a scale Standard Deviation 1.02	5.80 score on a scale Standard Deviation 1.06
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet 6 months	5.86 score on a scale Standard Deviation 1.02	5.76 score on a scale Standard Deviation 1.02
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet 12 months	5.78 score on a scale Standard Deviation 1.02	5.85 score on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise 12 months	5.79 score on a scale Standard Deviation 1.06	5.83 score on a scale Standard Deviation 1.04
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise baseline	5.81 score on a scale Standard Deviation 1.04	5.81 score on a scale Standard Deviation 1.07
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise 6 months	5.94 score on a scale Standard Deviation 1.00	5.74 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet baseline	3.19 score on a scale Standard Deviation 1.25	3.04 score on a scale Standard Deviation 1.23
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet 6 months	3.30 score on a scale Standard Deviation 1.09	3.23 score on a scale Standard Deviation 1.29
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet 12 months	3.36 score on a scale Standard Deviation 1.11	3.39 score on a scale Standard Deviation 1.31

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise 6 months	3.28 score on a scale Standard Deviation 1.24	3.29 score on a scale Standard Deviation 1.31
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise 12 months	3.17 score on a scale Standard Deviation 1.16	3.28 score on a scale Standard Deviation 1.27
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise baseline	3.20 score on a scale Standard Deviation 1.23	3.06 score on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

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.

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet baseline	2.30 score on a scale Standard Deviation 1.11	2.37 score on a scale Standard Deviation 1.09
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet 6 months	2.29 score on a scale Standard Deviation 1.04	2.45 score on a scale Standard Deviation 1.16
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet 12 months	2.47 score on a scale Standard Deviation 1.12	2.35 score on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: baseline, 6 month, and 12 month follow-up

Population: participants lost to follow up, withdrew, and/or removed from study per physician

Outcome measures

Outcome measures
Measure	Intervention n=157 Participants Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 Participants Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise baseline	2.27 score on a scale Standard Deviation 1.09	2.31 score on a scale Standard Deviation 1.08
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise 6 months	2.27 score on a scale Standard Deviation 1.07	2.46 score on a scale Standard Deviation 1.18
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise 12 months	2.55 score on a scale Standard Deviation 1.17	2.34 score on a scale Standard Deviation 1.08

OTHER_PRE_SPECIFIED outcome

Timeframe: through completion of administering the study intervention, an average of 4 years

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=157 participants at risk Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.	Usual Clinical Care n=159 participants at risk Usual care arm participants will receive routine hypertension clinical care per their primary care provider.
Cardiac disorders Cardiac disorders - Other	0.00% 0/157 • 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.	0.63% 1/159 • Number of events 1 • 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.
Gastrointestinal disorders	0.64% 1/157 • Number of events 1 • 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.	0.00% 0/159 • 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.
Infections and infestations	1.3% 2/157 • Number of events 3 • 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.	0.00% 0/159 • 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.
Musculoskeletal and connective tissue disorders Chest Wall Pain	0.00% 0/157 • 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.	0.63% 1/159 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/157 • 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.	0.63% 1/159 • Number of events 1 • 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.
Vascular disorders Vascular disorders - Other	0.00% 0/157 • 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.	0.63% 1/159 • Number of events 1 • 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.
General disorders	0.00% 0/157 • 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.	0.63% 1/159 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	0.00% 0/157 • 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.	0.63% 1/159 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.64% 1/157 • Number of events 1 • 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.	0.00% 0/159 • 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.

Other adverse events

Additional Information

Kara Hoppe, DO

University of Wisconsin School of Medicine and Public Health

Phone: 608-417-4224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place