Veterans Intensive Personalized Treatment in Heart Failure

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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 control. RESEARCH DESIGN: This is a practice-based RCT to test the effect of BI and BEI on medication and diet adherence. The study is embedded in typical VA healthcare with all 3 arms incorporating the enhancements in HF care that have been implemented including the Patient Aligned Care Teams (PACT), system redesign methods to improve HF care, ongoing HF quality improvement and Telehealth. 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 control 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 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.

Official Title
-----------------
VIP (Veterans Intensive Personalized) Treatment in Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Telephone-Delivered BI
* Behavioral: Telephone-Delivered BEI
* Other: Telephone-Delivered API


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone-Delivered BI<br>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. | Behavioral: Telephone-Delivered BI<br>* Behavioral Intervention will be delivered over the phone.<br>|
| Experimental: Telephone-Delivered BEI<br>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. | Behavioral: Telephone-Delivered BEI<br>* Behavioral and Environmental Intervention will be delivered over the phone<br>|
| Placebo Comparator: Telephone-Delivered API<br>Attention Placebo Intervention (API) - patients will receive non-tailored counseling on general health topics. | Other: Telephone-Delivered API<br>* Attention Placebo Intervention will be delivered over the phone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence (Refill Compliance for All HF Medications) | Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time. | 6 months from baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to ACE Inhibitors and ARB | Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time. | 6 months after baseline | 
| Adherence to Beta Blockers | Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time. | 6 months from baseline | 
| Self-reported Medication Adherence | Assessed using Morisky medication-taking scale. Higher score corresponds to worse adherence. | 6 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Telemedicine, Medication Adherence