mGlide RCT: A Clinical Glide Path To Close the Guideline-to-Practice Gap In HTN Management
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/17/2019 |
| Start Date: | February 25, 2019 |
| End Date: | April 30, 2023 |
| Contact: | Emily Vollbrecht |
| Email: | vollb007@umn.edu |
| Phone: | 612-626-7979 |
Hypertension (HTN) is the most important stroke and cardiovascular disease (CVD) risk factor.
Unfortunately, there is substantial under-treatment of HTN. Of the 86 million adults with
prevalent HTN in the U.S., 40 million (46%) have inadequately controlled blood pressure (BP).
This problem is worse among minority groups. In this study, the investigators demonstrate how
mHealth (mobile health technology) can improve HTN control rates in stroke survivors and
primary care patients without stroke, but who are at a high risk of stroke and CVD. Our
intervention is called mGlide. Intervention participants will self- monitor their BP daily
using a wireless BP monitor and a smart phone. The phone will transmit this BP to a database
automatically. The investigators will use the framework of glide paths to manage the
transmitted BP data. The glide path, based on the concept of landing an airplane, establishes
an expected trajectory of BP readings for each patient with bounds set by guidelines and
provider input. BP is monitored at home; the health care team is alerted when patient BP
deviates from expected bounds. Alerts are generated once a week for the health care team with
a list of patients with uncontrolled HTN. This facilitates early intervention while avoiding
information overload. Partnering clinical centers include Federally Qualified Health Centers
that serve low income and minority (Latino, African American, Hmong) communities. In this RCT
study, the investigators will randomize 450 participants with uncontrolled HTN to the mGlide
intervention (n=225) vs. state-of-clinical-care comparison (n=225).
Unfortunately, there is substantial under-treatment of HTN. Of the 86 million adults with
prevalent HTN in the U.S., 40 million (46%) have inadequately controlled blood pressure (BP).
This problem is worse among minority groups. In this study, the investigators demonstrate how
mHealth (mobile health technology) can improve HTN control rates in stroke survivors and
primary care patients without stroke, but who are at a high risk of stroke and CVD. Our
intervention is called mGlide. Intervention participants will self- monitor their BP daily
using a wireless BP monitor and a smart phone. The phone will transmit this BP to a database
automatically. The investigators will use the framework of glide paths to manage the
transmitted BP data. The glide path, based on the concept of landing an airplane, establishes
an expected trajectory of BP readings for each patient with bounds set by guidelines and
provider input. BP is monitored at home; the health care team is alerted when patient BP
deviates from expected bounds. Alerts are generated once a week for the health care team with
a list of patients with uncontrolled HTN. This facilitates early intervention while avoiding
information overload. Partnering clinical centers include Federally Qualified Health Centers
that serve low income and minority (Latino, African American, Hmong) communities. In this RCT
study, the investigators will randomize 450 participants with uncontrolled HTN to the mGlide
intervention (n=225) vs. state-of-clinical-care comparison (n=225).
Aim 1 will examine how well HTN is controlled in the two groups at 6 months and 12 months
after randomization. Aim 2 will examine mGlide usability for providers and provider
experience and satisfaction with mGlide. It will also examine whether medications are managed
differently for participants in the two groups. Aim 3 will examine whether patients are more
satisfied with care in the mGlide group, whether they are more "activated" and have a greater
sense of self-efficacy in managing their HTN. Aim 4 will be a cost-effectiveness analysis of
providing mGlide care. The long-term goal is to prevent stroke and improve cardiovascular
health in populations by increasing health system efficiency and effectiveness. The results
from our mGlide RCT will provide evidence for the use of readily available mHealth technology
for bridging the guideline-to-practice gap in HTN treatment in low resource health systems
serving minority groups.
after randomization. Aim 2 will examine mGlide usability for providers and provider
experience and satisfaction with mGlide. It will also examine whether medications are managed
differently for participants in the two groups. Aim 3 will examine whether patients are more
satisfied with care in the mGlide group, whether they are more "activated" and have a greater
sense of self-efficacy in managing their HTN. Aim 4 will be a cost-effectiveness analysis of
providing mGlide care. The long-term goal is to prevent stroke and improve cardiovascular
health in populations by increasing health system efficiency and effectiveness. The results
from our mGlide RCT will provide evidence for the use of readily available mHealth technology
for bridging the guideline-to-practice gap in HTN treatment in low resource health systems
serving minority groups.
Inclusion Criteria:
- Stroke survivors (ischemic stroke or intra-parenchymal hemorrhage) or patients who
have not had a stroke but carry a high risk of stroke or cardiovascular disease (CVD)
events (>7.5% over 10 years) as defined by the AHA/ACC guideline on risk
stratification9
- Diagnosis of uncontrolled HTN at the time of study enrollment (need not have stroke)
- Uncontrolled blood pressure (BP) defined as SBP >140 mm Hg at the last 2 clinic visits
in the 6 months prior to the screening date. Alternatively, if a patient was
discharged from the hospital in the 6 months prior to screening and does not have 2
clinic visits after hospital discharge, at least one hospital SBP in the last 2 days
of the hospital stay must be >140 mm Hg. Screening of uncontrolled HTN will be based
on Electronic Medical Record (EMR) BP data.
- Capable and willing to comply with the entire study protocol
- Able to give voluntary written informed consent
- English, Spanish or Hmong speaking
- Have a smart phone or mobile technology device (e.g. ipad) that can transmit BP from
the BP monitor. iOS and Android Compatible. (iOS 7 or higher: iPhone 4 or higher, iPod
touch 5th generation or higher, iPad 2nd generation or higher. Android 4.0 or higher.)
Exclusion Criteria:
- Unable or unwilling to give consent
- Any severe co-morbid illness including end stage kidney disease (ESRD), end stage
liver disease (ESLD) or when life expectancy is less than 1 year or if primary care
provider feels that medical complexity of the patient precludes clinical trial
participation
- Unable to complete study tasks
- Any serious psychiatric illness that, in the opinion of the investigator, would
interfere with subject treatment, assessment or compliance including significant
delusional disorders such as schizophrenia and bipolar illness.
- Do not speak English, Spanish or Hmong
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