Clinical trial NCT01162759: Home Blood Pressure Monitoring Project
Official title: Home Blood Pressure Monitoring Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension, intervention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2010-07-15
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this project is to improve hypertension control at Kaiser Permanente Colorado (KPCO) by implementing a population-based multi-factorial intervention that uses home BP monitors that can download BP readings to KPCO's health records via internet, interactive voice response (IVR) technology, and multidisciplinary care team. Participants will be randomized to either the home blood pressure monitoring group receiving the multi-factorial intervention or the usual care group who will be receiving Kaiser standard of care. We will determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines. The study hypothesis is that a higher proportion of patients with uncontrolled hypertension in the home blood pressure monitoring (HBPM) group will achieve their target blood pressure compared to those in the usual care (UC) group.

Detailed description: STUDY OBJECTIVES:

Primary:

• To determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines

Secondary:

The following parameters will be evaluated between groups:

* Change in BP measures between baseline and at 6 months
* Proportion of patients who are receiving antihypertensive treatments in accordance to national clinical practice guidelines
* Adherence to hypertensive medication regimen during the 6-month follow-up period
* Patient satisfaction with the care model.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 85 years At least 1 diagnosis for hypertension,

  * Receive primary care from one of the participating clinics,
  * The two most recent BPs documented within that last 24 months are elevated (SBP\>140 and/or DBP\>90)
  * Receiving \< 3 antihypertensive medications, and
  * Have access to a computer with a USB port.

Exclusion Criteria:

* Pregnant, or breast-feeding,
* Patients on dialysis or being followed by nephrology,
* Patients with coronary artery disease, given these patients are already followed by the Clinical Pharmacy Cardiac Risk Service (CPCRS),
* On KPCO "Do Not Call" or deceased list,
* PCP does not give permission to include patient in the study,
* BP is at or below target at the baseline study visit,
* Not English-speaking.

Primary outcomes:
measure: BP at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Colorado, Institute of Health Research
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: David J Magid, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Kari Olson, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Sarah J Billups, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. A pharmacist-led, American Heart Association Heart360 Web-enabled home blood pressure monitoring program. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):157-63. doi: 10.1161/CIRCOUTCOMES.112.968172. Epub 2013 Mar 5.