A Behavioral Intervention To Improve Hypertension Control In Veterans

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Behavioral Intervention to Improve Hypertension Control in Veterans

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: SMI
* Behavioral: HEI
* Behavioral: UC
* Behavioral: SMI
* Behavioral: HEI
* Behavioral: UC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage-matched intervention (SMI)<br>Stage-matched intervention (SMI) | Behavioral: SMI<br>* Stage-matched intervention<br>Behavioral: HEI<br>* Health Education Intervention<br>Behavioral: UC<br>* Usual Care<br>|
| Active Comparator: Health Education Intervention (HEI)<br>Health Education Intervention (HEI) | Behavioral: SMI<br>* Stage-matched intervention<br>Behavioral: HEI<br>* Health Education Intervention<br>Behavioral: UC<br>* Usual Care<br>|
| No Intervention: Usual Care (UC)<br>Usual Care (UC) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Control | Blood pressure Control at 6 months | 6 months | 
| Systolic Blood Pressure | Mean systolic Blood Pressure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Number of Cardio Exercise Hours From Baseline to 6 Months |  | baseline and 6 months | 
| Change in Morisky Score From Baseline to 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 | baseline and 6 months | 
| Diet Stage of Change | 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 months | 
| Exercise Stage of Change | 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. | 6 months | 
| Medication Stage of Change | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Behavior modification, Randomized controlled trial, Treatment effectiveness, Telemedicine, Prevention