A Behavioral Intervention To Improve Hypertension Control In Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00286754
First received: February 1, 2006
Last updated: September 8, 2014
Last verified: September 2014

February 1, 2006
September 8, 2014
July 2006
January 2010   (final data collection date for primary outcome measure)
Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Blood pressure at 6 and 12 months
Complete list of historical versions of study NCT00286754 on ClinicalTrials.gov Archive Site
Treatment adherence, quality of life, satisfaction and acceptability. Overall cost-effectiveness of the intervention. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Treatment adherence, quality of life, satisfaction and acceptability at 6 and 12 months. Overall cost-effectiveness of the intervention.
Not Provided
Not Provided
 
A Behavioral Intervention To Improve Hypertension Control In Veterans
A Behavioral Intervention to Improve Hypertension Control in Veterans

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.

We propose a randomized controlled trial to evaluate the effect of telephone-delivered interventions (SMI and HEI) to improve BP control.

Veterans with uncontrolled hypertension (n=533) will be randomized equally to 3 groups: 1) The SMI will use the Transtheoretical model (TTM) as the unifying framework. Veterans will receive TTM stage-matched counseling for exercise, diet, and medications via monthly counseling sessions. A social worker (SW) will assess each participant's behavior and deliver the appropriate tailored SMI based on their stage of change, decisional balance, self-efficacy and the skills model questions. 2) The HEI group receives monthly telephone calls by a SW during which they will receive education about hypertension management. 3) The UC group participates in all the in-person visits but does not receive monthly calls.

There will be an initial 6-month active intervention phase followed by a 6 month monitoring phase to assess sustainability. All participants will visit the VAMC's at baseline and at 3, 6, and 12 months. Outcomes of interest include BP; adherence (to diet, exercise and medications); quality of life; satisfaction; acceptability; cost and cost-effectiveness. Patients will be blinded to which of the intervention arms (SMI or HEI) they are in, SW's will be blinded to patient's BP and staff measuring outcomes will be blinded to study assignment. The study will be analyzed using longitudinal data analysis methods using an intention to treat strategy.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Behavioral: SMI
    Stage-matched intervention
  • Behavioral: HEI
    Health Education Intervention
  • Behavioral: UC
    Usual Care
  • Experimental: Arm 1
    Stage-matched intervention (SMI)
    Interventions:
    • Behavioral: SMI
    • Behavioral: HEI
    • Behavioral: UC
  • Active Comparator: Arm 2
    Health Education Intervention (HEI)
    Interventions:
    • Behavioral: SMI
    • Behavioral: HEI
    • Behavioral: UC
  • No Intervention: Arm 3
    Usual Care (UC)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
533
September 2011
January 2010   (final data collection date for primary outcome measure)

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 (< 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.

  • 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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286754
IIR 04-170
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Sundar Natarajan, MD MSc VA New York Harbor Health Care System
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP