NCT00201084

Brief Summary

The purpose of this study is to test the theory that a major factor in poor blood pressure (BP) control is that physicians fail to intensify antihypertensive therapy for their patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
670

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

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

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

4.8 years

First QC Date

September 16, 2005

Last Update Submit

July 17, 2014

Conditions

Cardiovascular DiseasesHeart DiseasesHypertension

Outcome Measures

Primary Outcomes (1)

  • Expressed as the proportion of patients with average clinic BP less than 140/90 mm Hg in the previous two visits (130/80 mm Hg if the patient also has diabetes)

    24 months

Secondary Outcomes (3)

  • Actual measure clinic systolic and diastolic BP, patient physician communication patterns

    24 months

  • Patient adherence to medication and healthy lifestyle

    24 months

  • Physician knowledge, attitude, and beliefs about JNC-7 goals and barriers to achievement of the treatment goals and cost

    24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Uncertainty reduction tools, at physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling

Behavioral: Uncertainty reduction

2

NO INTERVENTION

Usual primary care

Interventions

Uncertainty reductionBEHAVIORAL

At physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Kept appointment on index visit day (see patient sampling and recruitment methods below)
  • Had one previous visit to the setting within the past year and identified the setting as his/her usual source of care
  • Average clinic BP on index visit and one most recent previous visit was equal to or greater than 140 mm Hg systolic or 90 mm Hg diastolic (130/80 mm Hg if diabetic)
  • Acknowledges understanding of the study goals and methods and gives informed consent to participate in study measurements and other procedures

You may not qualify if:

  • Cognitive or other functional impairment sufficient to limit patient's ability to give informed consent, keep follow-up appointments, and participate actively in adherence to his or her treatment regimen
  • Renal insufficiencies or renal failure based on a recent serum creatinine greater than 2.0 or chart diagnosis
  • Planning to leave the Houston area within the next two years
  • Severe, life-threatening illness that makes hypertension treatment a secondary priority

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77098, United States

Location

Related Publications (4)

  • Pavlik VN, Greisinger AJ, Pool J, Haidet P, Hyman DJ. Does reducing physician uncertainty improve hypertension control?: rationale and methods. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):257-63. doi: 10.1161/CIRCOUTCOMES.109.849984.

    PMID: 20031846BACKGROUND

  • Grigoryan L, Pavlik VN, Hyman DJ. Characteristics, drug combinations and dosages of primary care patients with uncontrolled ambulatory blood pressure and high medication adherence. J Am Soc Hypertens. 2013 Nov-Dec;7(6):471-6. doi: 10.1016/j.jash.2013.06.004. Epub 2013 Jul 23.

    PMID: 23890931RESULT

  • Grigoryan L, Pavlik VN, Hyman DJ. Predictors of antihypertensive medication adherence in two urban health-care systems. Am J Hypertens. 2012 Jul;25(7):735-8. doi: 10.1038/ajh.2012.30. Epub 2012 Mar 22.

    PMID: 22441507RESULT

  • Hyman DJ, Pavlik VN, Greisinger AJ, Chan W, Bayona J, Mansyur C, Simms V, Pool J. Effect of a physician uncertainty reduction intervention on blood pressure in uncontrolled hypertensives--a cluster randomized trial. J Gen Intern Med. 2012 Apr;27(4):413-9. doi: 10.1007/s11606-011-1888-1. Epub 2011 Oct 27.

    PMID: 22033742RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • David J. Hyman, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

September 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

US(1)