VIP Treatment in Heart Failure

OBJECTIVES: 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 (QOL) in
veterans with heart failure (HF). This theory-based pilot 3-arm randomized controlled trial
(RCT) will base one active arm on the Transtheoretical Model (TTM), while the other active
arm will add environmental (built and human) tailoring to TTM. The overarching hypothesis
driving this proposal is that a behavioral intervention (BI), which uses the TTM, or a
behavioral and environment-tailored intervention (BEI) will lower HF recurrence and improve
QOL by better medication and diet adherence compared to attention placebo (AP).

RESEARCH DESIGN: This is a practice-based RCT to test the effect of BI and BEI on medication
and diet adherence. We will randomize 99 participants equally to BI, BEI and AP. All
analyses will be intent to treat.

METHODOLOGY: The study sites will be the VAMC's at Manhattan and Brooklyn. Participants will
be veterans with classes I-III HF with prescribed HF medication for 6 months. Men and
women ( 21 years) with history and clinical findings of chronic, stable HF of NYHA
functional class I (previously symptomatic/now asymptomatic), II, or III are eligible. They
must have an available phone and 2 clinic visits in the previous 1.5 years. Patients with
poor short-term survival (< 1 year), recent major surgery (< 3 months), temporarily in the
area, or those unable to provide consent will be excluded. After being screened for
eligibility, participants will come in for 2 study visits over the course of 6 months which
will last about 1.5-2 hours. At each visit, a research assistant (RA) will administer a
questionnaire assessing health behaviors including diet, exercise and medication and quality
of life. The RAs will also measure height, weight, take 6 BP readings, and send patients to
the lab for blood and urine samples. After the first clinic visit, participants will be
randomized to one of three telephone groups. All participants will receive 1 phone call per
month for 6 months which will last approximately 30-40 minutes. 1) The BI group will receive
TTM stage-matched counseling. The interventionist will assess how ready patients are for
change in terms of diet, medication, and exercise adherence and deliver a tailored
intervention discussing adherence barriers. 2) In the BEI, in addition to using the TTM, the
intervention will tailor environmental factors, such as availability of healthy food stores,
recreational facilities, and support from caregivers in helping participants follow
treatment recommendations. We will speak with participant's caregivers to educate them on
heart failure as well. The caregivers will receive a call every 2 months (3 in total)
lasting approximately 20-30 minutes. 3) The AP group will receive monthly telephone calls
during which they will receive general health education. Our primary analytic goal is to
estimate the medication adherence rate and QOL to power a larger study. We will also perform
1-sample Exact Binomial Tests comparing the active arms to the expected inactive (AP)
control rate of 47%. Since this is a pilot study, we will use a 5% type 1 error rate
(2-sided) for each test. All analyses will be intent to treat.

Inclusion Criteria:

- Men and women (21 years) with history and clinical findings of chronic, stable HF of
NYHA functional class I (previously symptomatic/now asymptomatic), II, or III.

- They must have an available phone and 2 clinic visits in the previous 1.5 years.

Exclusion Criteria:

- Patients with poor short-term survival (< 1 year)

- recent major surgery (< 3 months)

- temporarily in the area

- or those unable to provide consent will be excluded.

- Patients excluded and reason for exclusion will be recorded.