Clinical trial NCT01404988: Veterans Intensive Personalized Treatment in Heart Failure
Official title: VIP (Veterans Intensive Personalized) Treatment in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Telemedicine
Medication Adherence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-07-28
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Medication Adherence (Refill Compliance for All HF Medications)
timeFrame: 6 months from baseline visit
Secondary outcomes:
measure: Adherence to ACE Inhibitors and ARB
timeFrame: 6 months after baseline
measure: Adherence to Beta Blockers
timeFrame: 6 months from baseline
measure: Self-reported Medication Adherence
timeFrame: 6 months from baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Health Care System
state: New York
Study officials:
affiliation: VA New York Harbor Health Care System
name: Sundar Natarajan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: