Young Adult Hypertension Self-Management Clinical Trial

NCT ID: NCT03158051

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2022-02-08

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.

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).

Conditions

Hypertension; Blood Pressure; Lifestyle Risk Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Home Blood Pressure Monitoring

Intervention Type: 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.

Telephone Health Coaching

Intervention Type: 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.

Usual clinical care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kara Hoppe, DO

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, United States

Aurora Health Care

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30677485 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36735261 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HL132148

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534225

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\CARDIOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0372

Identifier Type: -

Identifier Source: org_study_id