NCT00201136

Brief Summary

This study will test the separate and combined effects of a continuous quality improvement (CQI) intervention for physicians (MDs) and a behavioral intervention for patients on blood pressure control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
574

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_2 hypertension

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

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 14, 2015

Status Verified

February 1, 2012

Enrollment Period

4.5 years

First QC Date

September 12, 2005

Last Update Submit

October 11, 2015

Conditions

Hypertension

Keywords

Behavioral interventionLifestyle modificationGuidelines

Outcome Measures

Primary Outcomes (1)

  • Change in systolic blood pressure

    6 months

Secondary Outcomes (3)

  • Change in diastolic BP

    6 months

  • Change in BP at 18 months

    18 months

  • Patient and MD adherence to intervention

    6 and 18 months

Study Arms (4)

MD-C/PT-C

NO INTERVENTION

Physician and patient control group.

MD-I/PT-C

EXPERIMENTAL

MD CQI-type intervention; Patient control

Behavioral: MD CQI-type intervention

MD-C/Pt-I

EXPERIMENTAL

MD control; patient behavioral intervention

Behavioral: Lifestyle interventions to lower blood pressure for patients

MD-I/Pt-I

EXPERIMENTAL

MD CQI-type intervention; Patient behavioral intervention

Behavioral: Lifestyle interventions to lower blood pressure for patientsBehavioral: MD CQI-type intervention

Interventions

Lifestyle interventions to lower blood pressure for patientsBEHAVIORAL

Weight loss, DASH dietary pattern, increased physical activity, reduced salt intake, moderation of alchohol intake.

MD-C/Pt-IMD-I/Pt-I
MD CQI-type interventionBEHAVIORAL

CQI-type intervention for MD adherence to JNC guidelines for BP management

MD-I/PT-CMD-I/Pt-I

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving primary care from participating physicians from practices in the Duke Primary Care Research Consortium
  • Hypertension

You may not qualify if:

  • Primary care doctor advises against enrollment
  • Pregnant, nursing, or planning pregnancy
  • Recent CVD event
  • Chronic kidney or liver disease
  • Active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • Svetkey LP, Pollak KI, Yancy WS Jr, Dolor RJ, Batch BC, Samsa G, Matchar DB, Lin PH. Hypertension improvement project: randomized trial of quality improvement for physicians and lifestyle modification for patients. Hypertension. 2009 Dec;54(6):1226-33. doi: 10.1161/HYPERTENSIONAHA.109.134874.

    PMID: 19920081DERIVED

  • Dolor RJ, Yancy WS Jr, Owen WF, Matchar DB, Samsa GP, Pollak KI, Lin PH, Ard JD, Prempeh M, McGuire HL, Batch BC, Fan W, Svetkey LP. Hypertension Improvement Project (HIP): study protocol and implementation challenges. Trials. 2009 Feb 26;10:13. doi: 10.1186/1745-6215-10-13.

    PMID: 19245692DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Laura P. Svetkey

    Duke University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2004

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 14, 2015

Record last verified: 2012-02

Locations

US(1)