VIP Treatment in Heart Failure

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 placebo group where patients will receive general health counseling. The overarching hypothesis is that the tailored interventions will lower heart failure recurrence and improve quality of life by better medication and diet adherence compared to attention placebo.

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.

• 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

• Experimental: Arm 1
  Comprehensive behavioral intervention (BI) - Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
  Intervention: Behavioral: Telephone-Delivered BI
• Experimental: Arm 2
  Behavioral & Environmental Intervention (BEI) - Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.
  Intervention: Behavioral: Telephone-Delivered BEI
• Placebo Comparator: Arm 3
  Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.
  Intervention: Other: Telephone-Delivered API

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.