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Improving Blood Pressure in Colorado

This study has been completed.
Sponsor:
Collaborators:
Department of Veterans Affairs
Denver Health Medical Center
Colorado Health Outcomes Program
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00520988
First received: August 23, 2007
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

We will improve hypertension control in Colorado by implementing a population-based intervention using interactive voice response (IVR) technology that will be delivered to patients in three healthcare systems across Colorado (Denver Health and Hospitals [DH], VA Colorado Healthcare System [VA], and Kaiser Permanente of Colorado [KPCO]). Together, these organizations serve over 1 million Coloradans. The IVR-based hypertension program will: 1) reach out to more patients using fewer resources than a traditional patient visit approach, 2) implement evidence based guidelines for therapy, 3) facilitate patients' acquisition of medications by allowing them to order and receive medications at home, and 4) enhance medication adherence using tailored educational and motivational messages.

HYPOTHESES:

  1. A sizable population of patients is at high risk for further cardiovascular morbidity and mortality, based on uncontrolled hypertension.
  2. An IVR-centered intervention among patients with diagnosed but uncontrolled hypertension is feasible.
  3. An IVR-centered intervention plus usual care for these patients improves BP control, compared to usual care alone.

Condition Intervention
Hypertension
 Behavioral: Use of telephone-based Interactive Voice Recognition system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Blood Pressure in Colorado

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • We will assess the primary measures of effectiveness (control of blood pressure) in the clinic at baseline and 6 months, for both the usual care plus IVR arm and usual care arm alone. [ Time Frame: 6 months of follow-up ] [ Designated as safety issue: No ]

Enrollment: 290
Study Start Date: March 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Usual care plus use of Interactive Voice Recognition system
 Behavioral: Use of telephone-based Interactive Voice Recognition system
Use of telephone-based Interactive Voice Recognition system, for reporting of health information and blood pressure measurements
No Intervention: 2
Usual care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • have diagnosed but uncontrolled hypertension
  • Most recent measurement and one other measurement of the 3 most recent blood pressure measurements in the past 2 years have a systolic pressure >140mmHg or a diastolic pressure >90mmHg. For patients with a diagnosis of diabetes or chronic kidney disease the blood pressure cut-offs will be systolic >130 mm Hg or a diastolic pressure > 80 mm Hg
  • not on organizational "do not call" lists or deceased lists
  • have been approved for invitation into the study by their physician
  • do not have a life-threatening illness
  • are not on more than 4 antihypertensive medications
  • can use a telephone
  • speak either English or Spanish

Exclusion Criteria:

  • on organizational "Do Not Call" list or deceased list
  • physician does not give permission for them to be included in the study
  • younger than 18 years of age
  • has a life-threatening illness
  • currently takes more than 4 anti-hypertension medications
  • does not have or cannot use a phone
  • does not speak English or Spanish (languages available in IVR)
  • does not want to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520988

Locations
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Kaiser Permanente Colorado
Metro Denver area, Colorado, United States
Sponsors and Collaborators
Kaiser Permanente
Department of Veterans Affairs
Denver Health Medical Center
Colorado Health Outcomes Program
Investigators
Principal Investigator: Michael Ho, MD PhD Department of Veterans Affairs
Principal Investigator: Edward Havranek, MD Denver Health Medical Center
Principal Investigator: David Magid, MD MPH Kaiser Permanente
  More Information

No publications provided by Kaiser Permanente

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00520988     History of Changes
Other Study ID Numbers: CCPD08FLA00228
Study First Received: August 23, 2007
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
hypertension
intervention
disease management
telephone-based
Hypertension: diagnosed but uncontrolled

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013