N/A
N=533
A Behavioral Intervention To Improve Hypertension Control In Veterans
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00286754 ↗Enrolled (actual)
533
Serious AEs
1.3%
Results posted
Apr 2015
Primary outcome: Primary: Blood Pressure Control — 0.646; 0.543; 0.458; 0.354 proportion of participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SMI (Behavioral); HEI (Behavioral); UC (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure Control |
0.646; 0.543; 0.458; 0.354; 0.457; 0.542 | 0.001 sig |
| PRIMARY Systolic Blood Pressure |
131.2; 131.8; 134.7 | 0.009 sig |
| SECONDARY Change in Proportion With BP Under Control From Baseline to 6 Months |
.197; .118; .019 | <0.000003 sig |
| SECONDARY Change in Systolic Blood Pressure From Baseline to 6 Months |
-4.7; -5.4; -2.7 | <0.009 sig |
| SECONDARY Change in Number of Cardio Exercise Hours From Baseline to 6 Months |
-0.29; 0.53; -0.43 | 0.880 |
| SECONDARY Change in Morisky Score From Baseline to 6 Months |
0.25; 0.25; 0.14 | 0.306 |
| SECONDARY Diet Stage of Change |
87; 73; 73; 69; 86; 97 | 0.011 sig |
| SECONDARY Exercise Stage of Change |
128; 124; 126; 28; 35; 44 | 0.012 sig |
| SECONDARY Medication Stage of Change |
148; 156; 163; 8; 3; 7 | 0.581 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
Patients with limited life expectancy ( 21 drinks/week)
- serious chronic conditions like AIDS
- tuberculosis
- lupus
- and end-stage renal failure
will be excluded.
- Other exclusions include inability to understand English
- Lack of a landline telephone
- Unable to follow the study protocol
- Recent major surgery (< 3 months)
- Patients who are temporarily in the area and plan to move in < 1 year or will not be available for follow-up
- Those unable to provide informed consent.
- All patients excluded and reason for exclusion will be recorded.
- Prior to recruitment, each patient will be informed about the study and informed consent obtained.
Data sourced from ClinicalTrials.gov (NCT00286754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.