NCT00520988

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

5.5 years

First QC Date

August 23, 2007

Last Update Submit

April 26, 2012

Conditions

Hypertension

Keywords

hypertensioninterventiondisease managementtelephone-basedHypertension: diagnosed but uncontrolled

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months of follow-up

Study Arms (2)

1

EXPERIMENTAL

Usual care plus use of Interactive Voice Recognition system

Behavioral: Use of telephone-based Interactive Voice Recognition system

2

NO INTERVENTION

Usual care

Interventions

Use of telephone-based Interactive Voice Recognition systemBEHAVIORAL

Use of telephone-based Interactive Voice Recognition system, for reporting of health information and blood pressure measurements

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Denver Health Medical Center

Denver, Colorado, United States

Location

Denver VA Medical Center

Denver, Colorado, United States

Location

Kaiser Permanente Colorado

Metro Denver Area, Colorado, United States

Location

Related Publications (1)

  • Welch LK, Olson KL, Snow KE, Pointer L, Lambert-Kerzner A, Havranek EP, Magid DJ, Ho PM. Systolic blood pressure control after participation in a hypertension intervention study. Am J Manag Care. 2011;17(7):473-8.

    PMID: 21819167DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Michael Ho, MD PhD

    Denver VA Medical Center

    PRINCIPAL INVESTIGATOR

  • Edward Havranek, MD

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

  • David Magid, MD MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 27, 2007

Study Start

March 1, 2006

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(3)