VIP Treatment in Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01404988
First received: July 27, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: Telephone-Delivered BI
Behavioral: Telephone-Delivered BEI
Other: Telephone-Delivered API

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: VIP (Veterans Intensive Personalized) Treatment in Heart Failure

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Medication Adherence [ Time Frame: 6 months from baseline visit ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Telephone-Delivered BI
Behavioral Intervention will be delivered over the phone.
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.
Behavioral: Telephone-Delivered BEI
Behavioral and Environmental Intervention will be delivered over the phone
Placebo Comparator: Arm 3
Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.
Other: Telephone-Delivered API
Attention Placebo Intervention will be delivered over the phone

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404988

Locations
United States, New York
VA New York Harbor Health Care System
New York, New York, United States, 10010
Sponsors and Collaborators
Investigators
Principal Investigator: Sundar Natarajan, MD MSc VA New York Harbor Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01404988     History of Changes
Other Study ID Numbers: RRP 11-238
Study First Received: July 27, 2011
Last Updated: April 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Heart Failure
Telemedicine
Medication Adherence

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014