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: May 8, 2015
Last verified: May 2015
  Purpose

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 Intervention
Hypertension
Behavioral: SMI
Behavioral: HEI
Behavioral: UC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Behavioral Intervention to Improve Hypertension Control in Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Blood Pressure Control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood pressure Control at 6 months

  • Systolic Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean systolic Blood Pressure


Secondary Outcome Measures:
  • Change in Proportion With BP Under Control From Baseline to 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure From Baseline to 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Number of Cardio Exercise Hours From Baseline to 6 Months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Morisky Score From Baseline to 6 Months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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

  • Diet Stage of Change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Exercise Stage of Change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Medication Stage of Change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 533
Study Start Date: July 2006
Study Completion Date: September 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286754

Locations
United States, New York
VA New York Harbor Health Care System
New York, New York, United States, 10010
Sponsors and Collaborators
Investigators
Principal Investigator: Sundar Natarajan, MD MSc VA New York Harbor Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00286754     History of Changes
Other Study ID Numbers: IIR 04-170
Study First Received: February 1, 2006
Results First Received: January 21, 2015
Last Updated: May 8, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hypertension
Behavior modification
Randomized controlled trial
Treatment effectiveness
Telemedicine
Prevention

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 26, 2015