Young Adult Hypertension Self-Management Clinical Trial

NCT03158051 | Completed Results DMC

• 4 other identifiers: 2017-0372R01HL132148A534225SMPH\MEDICINE\CARDIOLOGY
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension; Blood Pressure; Lifestyle Risk Reduction

Keywords

Hypertension; Young Adult; Self-Management; Health coach

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (18)

• Number of Participants That Achieve Hypertension Control at 6 Months

  up to 6 months

• Sodium Intake as Assessed by the 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

  baseline, 6 month, and 12 month follow-up

• Ounces of Whole Grain as Assessed by the 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

  baseline, 6 month, and 12 month follow-up

Other Outcomes (4)

• Health Coach Fidelity to the Study Intervention

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

• Adverse Events

  Through study completion, an average of 5 years

• Serious Adverse Events

  Through study completion, an average of 5 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Home Blood Pressure Monitoring; Behavioral: Telephone Health Coaching

Usual clinical care

NO INTERVENTION

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

Interventions

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.

Intervention

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (2)

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, 53792, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (2)

• 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.

  PMID: 30677485 BACKGROUND

• 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.

  PMID: 36735261 DERIVED

MeSH Terms

Conditions

Hypertension; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Kara Hoppe, DO
• Organization: University of Wisconsin School of Medicine and Public Health

khoppe2@wisc.edu

608-417-4224

Study Officials

• Kara Hoppe, DO

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: October 2, 2017
• Primary Completion: January 13, 2022
• Study Completion: February 8, 2022
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)