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Hypertension is an increasingly common problem in children, especially among those who are obese or with diabetes and chronic kidney disease. This study is a pilot randomized controlled trial designed to test whether improved blood pressure control can be achieved with the use of remote home blood pressure monitoring in children with uncontrolled blood pressure.
Hypertension is an increasingly common problem in children, especially among those who are obese or with diabetes and chronic kidney disease. This study is a pilot randomized controlled trial designed to test whether improved blood pressure control can be achieved with the use of remote home blood pressure monitoring in children with uncontrolled blood pressure. Study investigators will randomize 60 children who have elevated BP (defined as receipt of ≥1 anti-hypertensive agent or office SBP ≥90th percentile) to either home BP monitoring with a home SBP target of < 90th percentile or less than 120 mm Hg, which ever is lower (intervention group) versus usual care group in 2:1 ratio. This study aims to (1) compare the safety of BP lowering in intervention versus usual care patients, (2) determine the efficacy of the intervention and provide estimates for the refinement of sample size determination for an eventual full-scale trial, and (3) assess the feasibility and acceptability of the intervention, recruitment rates, and barriers to trial completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strict SBP Target | Experimental | Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower) |
|
| Usual SBP Target | No Intervention | Usual care, no home SBP target |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| strict blood pressure control | Other | Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achieved Blood Pressure | Time Frame: Months 4-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants screened who enroll in trial | Feasibility of enrollment | Months 0-12 |
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Inclusion Criteria:
Exclusion Criteria:
We will exclude those who:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Ku, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |