Veterans Intensive Personalized Treatment in Heart Failure

NCT01404988 | Completed Results

• 1 other identifier: RRP 11-238
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Telemedicine; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adherence to ACE Inhibitors and ARB

  6 months after baseline

• Adherence to Beta Blockers

  6 months from baseline

• Self-reported Medication Adherence

  6 months from baseline

Study Arms (3)

Telephone-Delivered BI

EXPERIMENTAL

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

Telephone-Delivered BEI

EXPERIMENTAL

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

Telephone-Delivered API

PLACEBO COMPARATOR

Attention Placebo Intervention (API) - patients will receive non-tailored counseling on general health topics.

Other: Telephone-Delivered API

Interventions

Telephone-Delivered BI BEHAVIORAL

Behavioral Intervention will be delivered over the phone.

Telephone-Delivered BI

Telephone-Delivered BEI BEHAVIORAL

Behavioral and Environmental Intervention will be delivered over the phone

Telephone-Delivered BEI

Telephone-Delivered API OTHER

Attention Placebo Intervention will be delivered over the phone

Telephone-Delivered API

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA New York Harbor Health Care System

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Heart Failure; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Sundar Natarajan, MD, M.Sc.
• Organization: VA New York Harbor Healthcare System

sundar.natarajan@va.gov

212-951-3395

Study Officials

• Sundar Natarajan, MD MSc

  VA New York Harbor Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 28, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: May 25, 2015
• Results First Posted: May 25, 2015

Record last verified: 2015-05

Locations

US (1)