A Behavioral Intervention To Improve Hypertension Control In Veterans

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: SMI; Behavioral: HEI; Behavioral: UC

• Registration Number: NCT00286754
• Lead Sponsor: US Department of Veterans Affairs

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-03
• Study Start: 2006-07
• Primary Completion: 2010-01
• Study Completion: 2011-09
• Results First Submitted: 2015-01-21
• Results First Submitted QC: 2015-04-08
• Results First Posted: 2015-04-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-08
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 533

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage-matched intervention (SMI)	SMI	Stage-matched intervention (SMI)
Stage-matched intervention (SMI)	HEI	Stage-matched intervention (SMI)
Health Education Intervention (HEI)	SMI	Health Education Intervention (HEI)
Stage-matched intervention (SMI)	UC	Stage-matched intervention (SMI)
Health Education Intervention (HEI)	UC	Health Education Intervention (HEI)
Health Education Intervention (HEI)	HEI	Health Education Intervention (HEI)

Primary Outcome Measures

Name	Time	Method
Blood Pressure Control	6 months	Blood pressure Control at 6 months
Systolic Blood Pressure	6 months	Mean systolic Blood Pressure

Secondary Outcome Measures

Name	Time	Method
Change in Number of Cardio Exercise Hours From Baseline to 6 Months	baseline and 6 months
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 Morisky Score From Baseline to 6 Months	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
Diet Stage of Change	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.
Exercise Stage of Change	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.
Medication Stage of Change	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.

Trial Locations

Locations (1)

VA New York Harbor Health Care System; 🇺🇸 New York, New York, United States