|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00286754 |
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: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Behavioral Intervention to Improve Hypertension Control in Veterans |
| Estimated Enrollment: | 528 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Stage-matched intervention (SMI)
|
Behavioral: SMI
Stage-matched intervention
|
|
2: Active Comparator
Health Education Intervention (HEI)
|
Behavioral: HEI
Health Education Intervention
|
|
3: No Intervention
Usual Care (UC)
|
Behavioral: UC
Usual Care
|
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=528) 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 |
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 any cancer other than non-melanoma skin 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, and 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| Contact: Michelle E Ulmer, BA | (212) 951-3395 | Michelle.Ulmer@va.gov |
| Contact: Donald Robinaugh, BS | (212) 951-3395 | donald.robinaugh@va.gov |
| United States, New York | |
| VA New York Harbor Health Care System | Recruiting |
| New York, New York, United States, 10010 | |
| Contact: Robert Meci 212-951-3323 ext 7474 Robert.Meci@va.gov | |
| Principal Investigator: Sundar Natarajan, MD MSc | |
| Principal Investigator: | Sundar Natarajan, MD MSc | VA New York Harbor Health Care System |
More Information
| Responsible Party: | Department of Veterans Affairs ( Natarajan, Sundar - Principal Investigator ) |
| Study ID Numbers: | IIR 04-170 |
| Study First Received: | February 1, 2006 |
| Last Updated: | November 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00286754 |
| Health Authority: | United States: Federal Government |
|
Hypertension Behavior modification Randomized controlled trial |
Treatment effectiveness Telemedicine Prevention |
|
Vascular Diseases Hypertension |
|
Cardiovascular Diseases |
