Hypertension Clinical Trial
— iSmartHypOfficial title:
Improving Hypertension Using a Smartphone-Enabled Personal Control Program: The Smart Hypertension Control Study
Verified date | April 2022 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators at Northwestern University will partner with Omron Healthcare Co., Ltd. (hereinafter referred to as "Omron") to conduct a randomized controlled trial of a hypertension personal control program (HPCP), known as Lark HTN Pro with a home blood pressure monitoring device (HBMD) compared to a HBMD alone. The overarching goal of this study is to investigate the effects of the HPCP on blood pressure, blood pressure self-management behaviors, and healthy lifestyle behaviors among adults with hypertension.
Status | Completed |
Enrollment | 333 |
Est. completion date | December 1, 2019 |
Est. primary completion date | April 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Adults aged 18 years to <85 years at the time of screening - Standardized mean blood pressure measurement =135 to <180 mmHg systolic or =85 to <110 mmHg diastolic - Have and use an iOS device(s) (iPhone generation 5s or newer) - Able to provide written informed consent prior to participation in the study - Receive their primary care from a Northwestern Medicine clinic site Exclusion Criteria: - Current user of the HCPC (Lark HTN Pro) - Standardized mean blood pressure measurement =180 mmHg systolic or =110 mmHg diastolic - Persistent atrial fibrillation as indicated in the electronic health record (EHR) - Pregnant or planning to become pregnant during the study period - Severe kidney disease, defined as estimated glomerular filtration rate <30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis) - Hearing impaired and unable to respond to phone calls - Lack of fluency in English - History of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, coronary artery bypass grafting) in the past 3 months - Diagnosis of dementia as indicated in the electronic health record - Diagnosis of psychosis as indicated in the electronic health record - Terminal cancer diagnosis or NYHA III or IV heart failure - Deemed unsuitable for study by primary care provider - Individuals requiring BP monitor cuff size larger than 17 inches or 42cm |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Medical Group | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Omron Healthcare Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Pressure at 6 Months | 6 months | ||
Primary | Blood Pressure <140/90mmHg | 6 months | ||
Secondary | Number of Antihypertensive Agents Used | Number of self reported antihypertensive medication drug classes taken | 6 months | |
Secondary | Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions | Number of antihypertensive drug classes that were increased, added or substituted for another drug class | 6 months | |
Secondary | Number of Health System Contacts (Telephone, Office, or Mychart Encounters) | 6 months | ||
Secondary | Frequency of Home Blood Pressure Measurements Per Month | Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred | 6 months | |
Secondary | Months When a Home Blood Pressure Reading is Obtained, No. | Number of months out of the 6 month study period when at least one home blood pressure reading was obtained | 6 months | |
Secondary | Self-efficacy: Confidence in Controlling High Blood Pressure | Self reported response to :How confident are you that you will be able to get your blood pressure controlled and keep it there during the next few months? Reponses were on a 5-point scale ranging from (1) not at all confident to (5) extremely confident. | 6 months | |
Secondary | BMI | Body mass index is calculated as the weight in kilograms divided by height in meters squared. | 6 months | |
Secondary | Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q | Sum of responses represents intake of foods associated with the Dietary Approaches to Stop Hypertension diet. Range is from 0 to 77 with a higher score indicating better diet. Scores 32 and below indicate a low-quality diet, scores 33 to 51 indicate a medium-quality diet, and scores greater than or equal to 52 indicate a high-quality diet. | 6 months | |
Secondary | Minutes Per Week of Self-reported Physical Activity | Self-reported physical activity in minutes per week of at least moderate exercise | 6 months | |
Secondary | Self-reported Sleep Duration | 6 months |
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