Veterans Intensive Personalized Treatment in Heart Failure
NCT01404988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2015-05-25
Summary
In the VIP (Veterans Intensive Personalized) Treatment in Heart Failure Study we will assess 2 novel interventions to enhance adherence and improve quality of life in veterans with heart failure. This 3-arm randomized controlled trial will base one active arm on how ready patients are for change in terms of diet and medication adherence and will tailor the intervention based on this. The other active arm will also assess how ready patients are for change, but will also include tailoring based on availability of environment resources, such as proximity to health food stores or social support, to further tailor the intervention. The last active arm is simply an attention group where patients will receive general health counseling in addition to background care that all patients receive. The overarching hypothesis is that the tailored interventions will lower heart failure (HF) recurrence and improve quality of life by better medication and diet adherence compared to attention placebo.
Conditions
Interventions
- BEHAVIORAL
-
Telephone-Delivered BI
Behavioral Intervention will be delivered over the phone.
- BEHAVIORAL
-
Telephone-Delivered BEI
Behavioral and Environmental Intervention will be delivered over the phone
- OTHER
-
Telephone-Delivered API
Attention Placebo Intervention will be delivered over the phone
Sponsors & Collaborators
-
US Department of Veterans Affairs
lead FED
Principal Investigators
-
Sundar Natarajan, MD MSc · VA New York Harbor Health Care System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2013-12-31
- Completion
- 2014-06-30
Countries
- United States
Study Locations
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