HypertensionMyHEARTNCT03158051
Young Adult Hypertension Self-Management Clinical Trial
A study testing Home Blood Pressure Monitoring and Telephone Health Coaching in people with Hypertension and Blood Pressure, run by University of Wisconsin, Madison at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Hypertension, Blood Pressure, Lifestyle Risk Reduction
- What is being tested?
- Home Blood Pressure Monitoring and Telephone Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Oct 2017to 8 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, 53792
Aurora Health Care
Milwaukee, Wisconsin, 53233
About this study
Official title: The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial
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.
Read the 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
- Being tested
- Home Blood Pressure Monitoring, Telephone Health Coaching
- Keywords
- Hypertension, Young Adult, Self-Management, Health coach
- Medical subject headings
- Hypertension, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Blood Pressure MonitoringBehavioural
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 CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Systolic Ambulatory Blood Pressure (mmHg)
24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
Measured: 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.
Measured: baseline, 6 month, and 12 month follow-up
Clinic Systolic Blood Pressure (mmHg)
Systolic Blood Pressure measured at baseline, 6 months, and 12 months.
Measured: 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.
Measured: baseline, 6 month, and 12 month follow-up
Secondary outcomes (18)
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.
Measured: up to 6 months
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
Measured: 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
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.
Measured: baseline, 6 month, and 12 month follow-up
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
Measured: baseline, 6 month, and 12 month follow-up
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
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
Home Blood Pressure Monitoring Frequency
Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months.
Measured: baseline, 6 month, and 12 month follow-up
Standing Weight (kg)
Weight (kg) measured at baseline, 6 months, and 12 months.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
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.
Measured: baseline, 6 month, and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start2 Oct 2017
- Primary completion13 Jan 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Kara Hoppe, DO, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158051
- Sponsor's protocol ID
- 2017-0372
- Other IDs
- R01HL132148, A534225, SMPH\MEDICINE\CARDIOLOGY
- Acronym
- MyHEART
- Status last verified
- May 2023
- First submitted
- 15 May 2017
- Last updated
- 17 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30677485Hoppe 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.
PubMed 36735261
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03158051
- Acronym / sponsor ID
- MyHEART / 2017-0372
- Conditions
- Hypertension, Blood Pressure, Lifestyle Risk Reduction
- Keywords
- Hypertension, Young Adult, Self-Management, Health coach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Wake Forest University Health Sciences
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Home Blood Pressure Monitoring, Behavioral: Telephone Health CoachingTelephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials |
| Usual clinical care | No intervention | –Usual care arm participants will receive routine hypertension clinical care per their primary care provider. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Blood Pressure MonitoringIntervention 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. | Behavioural | Intervention |
| Telephone Health CoachingIntervention 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. | Behavioural | Intervention |
Primary outcome
24-hour Systolic Ambulatory Blood Pressure (mmHg)
Time frame: baseline, 6 month, and 12 month follow-up
24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
24-hour Diastolic Ambulatory Blood Pressure (mmHg)
Time frame: baseline, 6 month, and 12 month follow-up
24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.
Clinic Systolic Blood Pressure (mmHg)
Time frame: baseline, 6 month, and 12 month follow-up
Systolic Blood Pressure measured at baseline, 6 months, and 12 months.
Clinic Diastolic Blood Pressure (mmHg)
Time frame: baseline, 6 month, and 12 month follow-up
Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months.
18 secondary outcomes
Number of Participants That Achieve Hypertension Control at 6 Months
Time frame: up to 6 months
Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Time frame: 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
Time frame: baseline, 6 month, and 12 month follow-up
Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Time frame: baseline, 6 month, and 12 month follow-up
Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment
Time frame: baseline, 6 month, and 12 month follow-up
Physical Activity as Assessed by the Godin Physical Activity Questionnaire
Time frame: baseline, 6 month, and 12 month follow-up
Home Blood Pressure Monitoring Frequency
Time frame: baseline, 6 month, and 12 month follow-up
Standing Weight (kg)
Time frame: baseline, 6 month, and 12 month follow-up
Perceived Competence as Assessed by the Perceived Competence Scale for Diet
Time frame: baseline, 6 month, and 12 month follow-up
Perceived Competence as Assessed by the Perceived Competence Scale for Exercise
Time frame: baseline, 6 month, and 12 month follow-up
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet
Time frame: baseline, 6 month, and 12 month follow-up
Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise
Time frame: baseline, 6 month, and 12 month follow-up
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Time frame: baseline, 6 month, and 12 month follow-up
Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Time frame: baseline, 6 month, and 12 month follow-up
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Time frame: baseline, 6 month, and 12 month follow-up
Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Time frame: baseline, 6 month, and 12 month follow-up
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet
Time frame: baseline, 6 month, and 12 month follow-up
Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise
Time frame: baseline, 6 month, and 12 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30677485Johnson 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.
- Derived from this study: PubMed 36735261Hoppe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Hoppe, DO principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Blood Pressure Monitoring and Telephone Health Coaching in people with Hypertension and Blood Pressure, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Systolic Ambulatory Blood Pressure (mmHg) (time frame: baseline, 6 month, and 12 month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158051, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.