Veterans Intensive Personalized Treatment in Heart Failure

NCT01404988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2015-05-25

Study results available
· View outcomes & findings →

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404988 on ClinicalTrials.gov