Young Adult Hypertension Self-Management Clinical Trial

Hypertension Clinical Trial

— MyHEART  

Official title:

The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158051
• Other study ID #: 2017-0372
• Secondary ID: R01HL132148A5342
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: February 8, 2022

Study information

• Verified date: May 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: February 8, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Willing and capable of giving written informed consent

• Willing to comply with all study procedures and be available for the duration of the study

• Males and females ages 18-39 years old at the start of the study (inclusive)

• A minimum of two hypertension ICD-10 coded visits with a provider (physician [MD, DO], physician assistant, nurse practitioner) on different dates in the last 24 months, with at least one code in the past 18 months

• Medically homed at an IRB approved healthcare system

Exclusion Criteria:

• History of medically determined Congestive Heart Failure

• Unable to provide informed consent (i.e., activated healthcare power of attorney)

• Unable or unwilling to travel to local clinic for research visits

• Currently residing in a skilled nursing facility

• Diagnosed with sickle cell anemia or cystic fibrosis

• Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years

• Syncope while exercising or doing strenuous activity within past 12 months

• Currently prescribed warfarin, novel oral anticoagulant, or insulin

• Planned organ transplant or prior transplant in the past 5 years

• Chemotherapy or radiation therapy within 6 the past months

• Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment

• Current participation or planning to participate in another clinical trial in the next 12 months

• Pregnant or planning to become pregnant in the next 12 months

• Planning to leave the geographic area in the next 6 months

• Health condition that will limit both increasing physical activity and changing diet

• Illegal drug use (other than marijuana) in the past 30 days

• Unable to read or communicate in English

• Currently on dialysis or seeing a Nephrologist

• Unaware or denies history of high blood pressure or hypertension

• Between-arm blood pressure difference >20 mmHg

• White Coat Hypertension (24-hour ambulatory monitoring)

• Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators

• Prisoners

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension
• Lifestyle Risk Reduction

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine & Public Health	Madison	Wisconsin
United States	Aurora Health Care	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Aurora Health Care, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Adverse Events	Number and type of adverse events	Through study completion, an average of 5 years
Other	Serious Adverse Events	Number and type of serious adverse events	Through study completion, an average of 5 years
Other	Withdrawal	Subject Withdrawal Rate	Through study completion, an average of 5 years
Primary	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
Primary	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
Primary	Clinic Systolic Blood Pressure (mmHg)	Systolic Blood Pressure measured at baseline, 6 months, and 12 months.	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.	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.	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	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.	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	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	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): 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.	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.	baseline, 6 month, and 12 month follow-up
Secondary	Standing Weight (kg)	Weight (kg) measured at baseline, 6 months, and 12 months.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	baseline, 6 month, and 12 month follow-up