A Behavioral Intervention To Improve Hypertension Control In Veterans
A Behavioral Intervention to Improve Hypertension Control in Veterans
1 other identifier
interventional
533
1 country
1
Brief Summary
The purpose of this study is to determine whether a stage-matched intervention (SMI) will lower BP and improve treatment adherence compared to usual care (UC) or a health education intervention (HEI) in veterans with uncontrolled BP. The study will also examine the effect of SMI on patient's health-related quality of life, satisfaction, acceptability and determine its cost-effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Jul 2006
Longer than P75 for not_applicable hypertension
1 active site
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
First Submitted
Initial submission to the registry
February 1, 2006
CompletedFirst Posted
Study publicly available on registry
February 3, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
April 9, 2015
CompletedJune 1, 2015
May 1, 2015
3.5 years
February 1, 2006
January 21, 2015
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Blood Pressure Control
Blood pressure Control at 6 months
6 months
Systolic Blood Pressure
Mean systolic Blood Pressure
6 months
Secondary Outcomes (7)
Change in Proportion With BP Under Control From Baseline to 6 Months
6 months
Change in Systolic Blood Pressure From Baseline to 6 Months
Baseline and 6 months
Change in Number of Cardio Exercise Hours From Baseline to 6 Months
baseline and 6 months
Change in Morisky Score From Baseline to 6 Months
baseline and 6 months
Diet Stage of Change
6 months
- +2 more secondary outcomes
Study Arms (3)
Stage-matched intervention (SMI)
EXPERIMENTALStage-matched intervention (SMI)
Health Education Intervention (HEI)
ACTIVE COMPARATORHealth Education Intervention (HEI)
Usual Care (UC)
NO INTERVENTIONUsual Care (UC)
Interventions
Eligibility Criteria
You may qualify if:
- Patients receiving continuity of care in the outpatient clinics will be eligible. This will be operationalized as 2 visits in the previous year.
- Adults (= 21 years) with hypertension, on antihypertensive medication for = 1 year, and who have current uncontrolled BP will be enrolled.
- Patients with CVD:
- chronic stable angina
- unstable angina
- uncomplicated myocardial infarction
- coronary artery bypass surgery
- percutaneous coronary angioplasty
- atherectomy or stent placement
- chronic stable angina pectoris
- stable Class I or Class II congestive heart failure
- stroke
- peripheral vascular disease
- will be entered into the study if the CVD event or diagnosis occurred = 6 months ago.
You may not qualify if:
- Patients with limited life expectancy (\< 1 year) due to severe co-existing non-CVD disease such as:
- terminal illnesses such as terminal cancer
- CVD \< 6 months ago
- Class III or IV CHF
- severe psychiatric illness such as psychosis
- manic depression
- alcohol abuse (\> 21 drinks/week)
- serious chronic conditions like AIDS
- tuberculosis
- lupus
- and end-stage renal failure
- will be excluded.
- Lack of a landline telephone
- Unable to follow the study protocol
- Recent major surgery (\< 3 months)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA New York Harbor Health Care System
New York, New York, 10010, United States
Related Publications (4)
Ulmer M, Robinaugh D, Friedberg JP, Lipsitz SR, Natarajan S. Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention. Contemp Clin Trials. 2008 Sep;29(5):705-10. doi: 10.1016/j.cct.2008.04.005. Epub 2008 May 6.
PMID: 18565801RESULTFriedberg JP, Lipsitz SR, Natarajan S. Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure. Patient Educ Couns. 2010 Jan;78(1):5-11. doi: 10.1016/j.pec.2009.04.009. Epub 2009 Jun 13.
PMID: 19525084RESULTFriedberg JP, Rodriguez MA, Watsula ME, Lin I, Wylie-Rosett J, Allegrante JP, Lipsitz SR, Natarajan S. Effectiveness of a tailored behavioral intervention to improve hypertension control: primary outcomes of a randomized controlled trial. Hypertension. 2015 Feb;65(2):440-6. doi: 10.1161/HYPERTENSIONAHA.114.03483. Epub 2014 Nov 17.
PMID: 25403606RESULTRodriguez MA, Wang B, Hyoung S, Friedberg J, Wylie-Rosett J, Fang Y, Allegrante JP, Lipsitz SR, Natarajan S. Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial. Hypertension. 2021 Jun;77(6):1867-1876. doi: 10.1161/HYPERTENSIONAHA.120.15192. Epub 2021 May 12.
PMID: 33979183DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sundar Natarajan, MD, Staff Physician
- Organization
- Department of Veterans Affairs
Study Officials
- PRINCIPAL INVESTIGATOR
Sundar Natarajan, MD MSc
VA New York Harbor Health Care System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2006
First Posted
February 3, 2006
Study Start
July 1, 2006
Primary Completion
January 1, 2010
Study Completion
September 1, 2011
Last Updated
June 1, 2015
Results First Posted
April 9, 2015
Record last verified: 2015-05