MyHEART: Young Adult Hypertension Self-Management Clinical Trial

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT03158051

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Aurora Health Care (Other)

316

Enrollment

Locations

Arms

52.2

Actual Duration (Months)

158

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Blood Pressure Lifestyle Risk Reduction	Behavioral: Home Blood Pressure Monitoring Behavioral: Telephone Health Coaching	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

316 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 2, 2017

Actual Primary Completion Date :

Jan 13, 2022

Actual Study Completion Date :

Feb 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials	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. Behavioral: 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.
No Intervention: Usual clinical care Usual care arm participants will receive routine hypertension clinical care per their primary care provider.

Arm

Intervention/Treatment

Experimental: Intervention

Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials

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.

Behavioral: 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.

No Intervention: Usual clinical care

Usual care arm participants will receive routine hypertension clinical care per their primary care provider.

Outcome Measures

Primary Outcome Measures

24-hour Systolic Ambulatory Blood Pressure (mmHg) [6 month and 12 month follow-up]
Change in 24-hour Systolic Ambulatory Blood Pressure from baseline
24-hour Diastolic Ambulatory Blood Pressure (mmHg) [6 month and 12 month follow-up]
Change in 24-hour Diastolic Ambulatory Blood Pressure from baseline

Secondary Outcome Measures

Change in Standing Weight (kg) [6 month and 12 month follow-up]
Change in Weight (kg) from baseline
Change in Body mass index (BMI) (kg/m2) [6 month and 12 month follow-up]
Change in BMI (kg/m2) from baseline
Change in Waist circumference (cm) [6 month and 12 month follow-up]
Change in waist circumference (cm) from baseline
Change in Home blood pressure monitoring frequency [6 month and 12 month follow-up]
Change in self-report of home blood pressure monitoring frequency (times/week) from baseline
Change in Perceived Competence as assessed by the Perceived Competence Scale [6 month and 12 month follow-up]
Change in perceived competence from baseline as assessed by the Perceived Competence Scale (self-administration)
Change in Perceived Autonomy as assessed by the Health Care Climate Questionnaire [6 month and 12 month follow-up]
Change in perceived autonomy from baseline as assessed by the Health Care Climate Questionnaire (self-administration)
Change in Autonomous Motivation as assessed by the Treatment Self-Regulation Questionnaire [6 month and 12 month follow-up]
Change in autonomous motivation from baseline as assessed by the Treatment Self-Regulation Questionnaire (self-administration)
Change in Sodium Intake as assessed by the Automated Self-Administered 24-hour Dietary Assessment [6 month and 12 month follow-up]
Change in mean daily sodium intake (grams/day) from baseline as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment
Change in Physical Activity as assessed by the Godin Physical Activity Questionnaire [6 month and 12 month follow-up]
Change in mean daily and weekly amounts of physical activity as assessed by the Godin Physical Activity Questionnaire

Other Outcome Measures

Health Coach Fidelity to the Study Intervention [through completion of administering the study intervention, an average of 4 years]
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
Adverse Events [Through study completion, an average of 5 years]
Number and type of adverse events
Serious Adverse Events [Through study completion, an average of 5 years]
Number and type of serious adverse events
Withdrawal [Through study completion, an average of 5 years]
Subject Withdrawal Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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