Clinical trial NCT00286754: A Behavioral Intervention To Improve Hypertension Control In Veterans
Official title: A Behavioral Intervention to Improve Hypertension Control in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Behavior modification
Randomized controlled trial
Treatment effectiveness
Telemedicine
Prevention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-02-03
Enrollment: 533
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Blood Pressure Control
timeFrame: 6 months
measure: Systolic Blood Pressure
timeFrame: 6 months
Secondary outcomes:
measure: Change in Proportion With BP Under Control From Baseline to 6 Months
timeFrame: 6 months
measure: Change in Systolic Blood Pressure From Baseline to 6 Months
timeFrame: Baseline and 6 months
measure: Change in Number of Cardio Exercise Hours From Baseline to 6 Months
timeFrame: baseline and 6 months
measure: Change in Morisky Score From Baseline to 6 Months
timeFrame: baseline and 6 months
measure: Diet Stage of Change
timeFrame: 6 months
measure: Exercise Stage of Change
timeFrame: 6 months
measure: Medication Stage of Change
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Health Care System
state: New York
Study officials:
affiliation: VA New York Harbor Health Care System
name: Sundar Natarajan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ulmer M, Robinaugh D, Friedberg JP, Lipsitz SR, Natarajan S. Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention. Contemp Clin Trials. 2008 Sep;29(5):705-10. doi: 10.1016/j.cct.2008.04.005. Epub 2008 May 6.
citation: Friedberg JP, Lipsitz SR, Natarajan S. Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure. Patient Educ Couns. 2010 Jan;78(1):5-11. doi: 10.1016/j.pec.2009.04.009. Epub 2009 Jun 13.
citation: Friedberg JP, Rodriguez MA, Watsula ME, Lin I, Wylie-Rosett J, Allegrante JP, Lipsitz SR, Natarajan S. Effectiveness of a tailored behavioral intervention to improve hypertension control: primary outcomes of a randomized controlled trial. Hypertension. 2015 Feb;65(2):440-6. doi: 10.1161/HYPERTENSIONAHA.114.03483. Epub 2014 Nov 17.
citation: Rodriguez MA, Wang B, Hyoung S, Friedberg J, Wylie-Rosett J, Fang Y, Allegrante JP, Lipsitz SR, Natarajan S. Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial. Hypertension. 2021 Jun;77(6):1867-1876. doi: 10.1161/HYPERTENSIONAHA.120.15192. Epub 2021 May 12.