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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL138332-01A1 | U.S. NIH Grant/Contract | View source | |
| STUDY00003494 | Other Identifier | University of Minnesota IRB |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mGlide Intervention | Experimental | Participants will be educated on HTN and taught to self-monitor their BP. The transmitted BP will be used for adjustment of anti-HTN medications as it occurs in clinical practice. |
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| Clinical Care Comparison | No Intervention | Patients will be educated similar to intervention and taught self-monitoring of BP. Then they will be asked to follow up with primary care as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mGlide | Behavioral | BP will be automatically transmitted to the providers. The transmitted BP will be used for adjustment of anti-HTN medications as it occurs in clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| SBP | Systolic Blood Pressure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HTN Contol | Alive and SBP < 140 mmHg and Alive and SBP < 130 mmHg | 6 months and 12 months |
| Sustained BP control | SBP | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and side effects | Adverse events and medication side effects | 6 months and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamakshi Lakshminarayan, MD, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epidemiology Clinical Research Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41717677 | Derived | Lakshminarayan K, Murray TA, Lunos S, McCarthy T, Everson-Rose SA, Overton V, Drawz PE, Streib C, Sakboonyarat B, Hatch H, Hibbard JH, Luepker RV, Connett J, Westberg SM. mHealth Intervention to Improve Hypertension Care in High-Risk Patients. Hypertension. 2026 Apr;83(4):e26148. doi: 10.1161/HYPERTENSIONAHA.125.26148. Epub 2026 Feb 20. | |
| 34534134 | Derived | Northuis CA, Murray TA, Lutsey PL, Butler KR, Nguyen S, Palta P, Lakshminarayan K. Body mass index prediction rule for mid-upper arm circumference: the atherosclerosis risk in communities study. Blood Press Monit. 2022 Feb 1;27(1):50-54. doi: 10.1097/MBP.0000000000000567. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The PI does not have any access to outcomes until unblinding. The BP outcomes are collected by a blinded research staff.
| 33492231 | Derived | Lakshminarayan K, Murray TA, Westberg SM, Connett J, Overton V, Nyman JA, Culhane-Pera KA, Pergament SL, Drawz P, Vollbrecht E, Xiong T, Everson-Rose SA. Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 25;10(1):e25424. doi: 10.2196/25424. |