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A Behavioral Intervention To Improve Hypertension Control In Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286754
Recruitment Status : Completed
First Posted : February 3, 2006
Results First Posted : April 9, 2015
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: SMI Behavioral: HEI Behavioral: UC Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 533 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Behavioral Intervention to Improve Hypertension Control in Veterans
Study Start Date : July 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stage-matched intervention (SMI)
Stage-matched intervention (SMI)
 Behavioral: SMI
Stage-matched intervention

Behavioral: HEI
Health Education Intervention

Behavioral: UC
Usual Care
Active Comparator: Health Education Intervention (HEI)
Health Education Intervention (HEI)
 Behavioral: SMI
Stage-matched intervention

Behavioral: HEI
Health Education Intervention

Behavioral: UC
Usual Care
No Intervention: Usual Care (UC)
Usual Care (UC)


Outcome Measures
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Primary Outcome Measures :
  1. Blood Pressure Control [ Time Frame: 6 months ]
    Blood pressure Control at 6 months

  2. Systolic Blood Pressure [ Time Frame: 6 months ]
    Mean systolic Blood Pressure


Secondary Outcome Measures :
  1. Change in Proportion With BP Under Control From Baseline to 6 Months [ Time Frame: 6 months ]
  2. Change in Systolic Blood Pressure From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]
  3. Change in Number of Cardio Exercise Hours From Baseline to 6 Months [ Time Frame: baseline and 6 months ]
  4. Change in Morisky Score From Baseline to 6 Months [ Time Frame: baseline and 6 months ]
    Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent

  5. Diet Stage of Change [ Time Frame: 6 months ]
    The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.

  6. Exercise Stage of Change [ Time Frame: 6 months ]
    The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.

  7. Medication Stage of Change [ Time Frame: 6 months ]
    The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (< 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286754


Locations
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United States, New York
VA New York Harbor Health Care System
New York, New York, United States, 10010
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Sundar Natarajan, MD MSc VA New York Harbor Health Care System
More Information
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Publications of Results:

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00286754    
Other Study ID Numbers: IIR 04-170
First Posted: February 3, 2006    Key Record Dates
Results First Posted: April 9, 2015
Last Update Posted: June 1, 2015
Last Verified: May 2015
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Hypertension
Behavior modification
Randomized controlled trial
 Treatment effectiveness
Telemedicine
Prevention
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases