The Congestive Heart Failure Adherence Redesign Trial

NCT01698242 | Completed Phase 3 DMC

• 1 other identifier: 10030801
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether a culturally sensitive self-management (SM) intervention, compared to an education only control, will reduce all-cause hospital days in patients with mild to moderate heart failure and household income less than $30,000 per year.

Conditions

Heart Failure, Congestive; Cardiovascular Diseases; Heart Diseases

Keywords

Heart failure; Self-Management; Behavioral Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Total number of all cause hospitalization days

  Participant's are queried quarterly concerning any hospitalizations occuring since the previous contact. These self-reported events are then confirmed via study adjudication of pertinent acquired hospital medical records. Analysis of the primary outcome will consist of comparing mean total number of all-cause hospitalization days between the two intervention groups. Analyses will also be performed with respect to the following pre-determined subgroups: (Primary Healthcare Provider subgroups) medical specialty, academic rank, "adherent" to evidence-based guidelines at baseline, and number of years since certification; (Patient Participant subgroups) age, gender, ethnicity, insurance status, years of education, health literacy, number of comorbidities, medication adherence at baseline, heart failure functional capacity, baseline BNP, presence of major stress and/or psychological trauma, perceived social support, number of years since first heart failure diagnosis, and self-efficacy

  Measured over the 30 month patient participant follow-up period

Secondary Outcomes (16)

• Total number of heart failure related hospitalization days

  measured over the 30 month patient participant follow-up period

• Health Care Costs

  Measured over the 30 monthstudy follow-up period

• Distance traveled during th Six-Minute Walk test

  This test is administered during in-person participant assessment visits conducted at baseline and at 6 and 30 months following treatment assignmentMeasured over/after 30 months

• The Kansas City Cardiomyopathy Questionnaire

  This questionnaire is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.

• Patient Medication Adherence

  Adherence is measured at baseline and at 6 and 30 months following treatment assignment

Study Arms (2)

Enhanced Training

EXPERIMENTAL

The Enhanced Training intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. Randomization occurs at the PCP-level, that is, patients are assigned to the Enhanced Training group only if their PCP has been enrolled and randomized to this group. Descriptions of the intervention on the PCP-level and patient-level are provided in the intervention section.

Behavioral: Enhanced Training

Enhanced Education

ACTIVE COMPARATOR

The Enhanced Education intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. The intervention strategy revolves around providing nominal information through the mail. Randomization occurs at the PCP-level; that is, patients are assigned to the Enhanced Education group only if their PCP already has been enrolled and randomized to this group. Description of the intervention on the PCP-level and patient-level is provided in the intervention section.

Behavioral: Enhanced Education

Interventions

Enhanced Training BEHAVIORAL

PCP-Level: A PCP randomized to the Enhanced Training (ET) group will receive: 1) a full and pocket sized copy of the current AHA Heart Failure (HF) Guidelines; 2) a summary of their patient's data collected at baseline, 6-month, and 30-month in-person study visits; and 3) an invitation to complete the CHART-designed online course in HF management for CME credit. Patient Level: The ET patient-level intervention uses Community Health Workers (CHWs) to assist the patient in learning self-management behaviors to reduce the risk of hospitalization. The key objectives are to: improve heart failure knowledge; encourage use of HF management tools; and facilitate development of self-management skills. Each participant receives at least: six AHA educational mailings, six monthly home visits, and 18 phone calls by CHWs within the first six months of the intervention. The CHW then conducts monthly telephone visits for the subsequent two years (for a total of 30 months of follow-up).

Enhanced Training

Enhanced Education BEHAVIORAL

The Enhanced Education (EE) intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. The intervention provides nominal information through the mail. Randomization occurs at the PCP-level; patients are assigned to the EE group only if their PCP already has been randomized to this group. PCP Level: Upon randomization to the EE group each PCP will receive a full-sized copy of the current American Heart Association (AHA) Heart Failure Guidelines within thirty days after randomization. Patient Level: Upon their assignment to the EE group, patients will receive: Six AHA Tip-Sheet mailings (one Tip-Sheet to be mailed each of the first six months following group assignment); a telephone call, made by the CHART Research Assistant (RA), completed once during each of the first six months following group assignment and only to confirm that the patient received the Tip-Sheet mailing for that month.

Enhanced Education

Eligibility Criteria

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

You may qualify if:

• Participant has been diagnosed with Heart Failure (HF),
• Self reported family income is less than $30,000/year,
• Has experienced at least one hospitalization for acute, decompensated, HF within the previous 6 months based upon:
• Being admitted for symptoms of HF (ex: peripheral edema, shortness of breath and fatigue), and
• responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ACE Inhibitors, ARBs, or Beta blockers.
• Has evidence of systolic dysfunction, defined by an ejection \<50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year.
• Age ≥ 18 years
• Currently resides in Cook County, Illinois.
• Speaks English or Spanish.
• The primary care provider (PCP) has consented and has no more than 12 patients enrolled.
• Completed the informed consent process.
• Successfully completed the 30-day run-in period and study baseline visit

You may not qualify if:

• Health providers will be excluded from enrollment if they are:
• Still in their residency or training period,
• A member of the CHART research staff.
• Patients will be excluded from enrollment if they have:
• \. An uncertain 12-month prognosis.
• Listed for imminent cardiac transplant.
• Has an advanced directive of "Do not resuscitate".
• Has uncertain 12-Month Prognosis, as adjudicated by the Principal Investigator

Sponsors & Collaborators

• Lynda Powell, PhD, MEd: lead
• Cook County Health: collaborator
• Sinai Health System: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

• Calvin JE, Shanbhag S, Avery E, Kane J, Richardson D, Powell L. Adherence to evidence-based guidelines for heart failure in physicians and their patients: lessons from the Heart Failure Adherence Retention Trial (HART). Congest Heart Fail. 2012 Mar-Apr;18(2):73-8. doi: 10.1111/j.1751-7133.2011.00263.x. Epub 2011 Nov 3.

  PMID: 22432552 BACKGROUND

• Powell LH, Calvin JE Jr, Mendes de Leon CF, Richardson D, Grady KL, Flynn KJ, Rucker-Whitaker CS, Janssen I, Kravitz G, Eaton C; Heart Failure Adherence and Retention Trial Investigators. The Heart Failure Adherence and Retention Trial (HART): design and rationale. Am Heart J. 2008 Sep;156(3):452-60. doi: 10.1016/j.ahj.2008.05.011.

  PMID: 18760125 BACKGROUND

• de Leon CF, Grady KL, Eaton C, Rucker-Whitaker C, Janssen I, Calvin J, Powell LH. Quality of life in a diverse population of patients with heart failure: BASELINE FINDINGS FROM THE HEART FAILURE ADHERENCE AND RETENTION TRIAL (HART). J Cardiopulm Rehabil Prev. 2009 May-Jun;29(3):171-8. doi: 10.1097/HCR.0b013e31819a0266.

  PMID: 19471136 BACKGROUND

• Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.

  PMID: 20858878 BACKGROUND

• Rucker-Whitaker C, Flynn KJ, Kravitz G, Eaton C, Calvin JE, Powell LH. Understanding African-American participation in a behavioral intervention: results from focus groups. Contemp Clin Trials. 2006 Jun;27(3):274-86. doi: 10.1016/j.cct.2005.11.006. Epub 2006 Jan 19.

  PMID: 16427365 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Heart Diseases

Study Officials

• Lynda H. Powell, PhD

  Chairperson and Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: October 2, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

US (1)