Continual vs. Routine Home Blood Pressure Monitoring and Management in Diverse Community Practice: CHANGE-BP
Withdrawn before enrolling · Not applicable
Conditions studied: Hypertension
In brief
The purpose of the CHANGE-BP study is to examine the change in in-office measured Blood Pressure (BP) from baseline to end of study (6-months) between participants randomized to either 1) Continual Blood Pressure Monitoring (CBPM), which includes receiving Aktiia's novel cuffless BP Research System that has an accompanying Aktiia Patient Interface smartphone application, and care delivered through a centralized Aktiia Provider Interface that displays device data and is accessible by a health care professional or 2) Home Blood Pressure Monitoring (HBPM), which includes a standard oscillometric blood pressure cuff and the standard blood pressure management care from a participant's primary care physician.
Key facts
- Study ID
- NCT05746117
- Run by
- Aktiia SA
- People needed
- 0
- Starts
- 2024-12-15
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2025-02-18
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 21-80 years old
- Owns a smartphone that is an Android or iOS with a data plan
- Fluent in written and spoken English as the technology is currently only available in English
- Average of 3 BP readings in last 18 months of >140/90 OR last in-office BP >140/90 in the last 6 months as documented in their Electronic Health Record
- Is a patient with Providence Health
- Willing to attend the 2 in-person study visits
- Is not participating in another study that is designed to influence blood pressure
- Willing to wear the Aktiia bracelet for 6 months
- Willing to be randomized to either group
- Had a BMP in the last 12 months or is willing to get one at the discretion of the clinical pharmacist as standard of care
You may not qualify if…
- Blood pressure at the baseline in-office visit is too low (SBP <140 mmHg AND DBP <90 mmHg) OR is too high (SBP > 190 mmHg OR DBP > 120 mmHg)
- Tachycardia (heart rate at rest > 120bpm)
- Atrial fibrillation, persistent or chronic
- Cardiomyopathy with LVEF <40% documented within the past year
- Diabetes Mellitus
- Under active treatment for hyperthyroidism
- Myxedema coma
- Subclavian stenosis
- Pheochromocytoma
- Raynaud's disease
- Trembling and shivering
- Known pregnancy
- Breastfeeding
- Arteriovenous fistula
- Arm amputation
- Exfoliative skin disease
- Lymphedema
- Known allergy to silicone
- Terminal medical condition with a life expectancy less than 2 years
- CKD 4-5 (eGFR ≤ 30 mL/min)
- Upper arm circumference < 22 cm or > 42 cm
- Wrist circumference < 14 cm or > 21 cm
- Adults unable to consent or who need a legally authorized representative to consent
- Currently incarcerated or detained in accordance with federal regulations regarding prisoners (e.g., 45 CFR 46 Subpart C)
- Diagnosed whitecoat hypertension
Where it is running
- Providence Health & Services — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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