NCT00260650

Brief Summary

The purpose of this study was to determine the efficacy of a self-management program, called the Heart PACT Program, compared to usual health care in patients with heart failure. Outcomes measured were patient activation (skills needed to maintain function, collaborate with providers, and access care), self-care management, hospitalizations and emergency department visits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

4 years

First QC Date

November 29, 2005

Last Update Submit

October 4, 2019

Conditions

Heart Failure

Keywords

heart failure, congestiveself-carequality of lifehealth behavior

Outcome Measures

Primary Outcomes (1)

  • patient activation

    baseline, 3 months, 6 months

Secondary Outcomes (1)

  • self-management

    baseline, 3 months, 6 months

Study Arms (2)

Heart PACT Program

EXPERIMENTAL

Heart PACT Program - patient activation intervention

Behavioral: Heart PACT Program

Usual Care

NO INTERVENTION

Usual Care

Interventions

Heart PACT ProgramBEHAVIORAL

patient activation intervention

Heart PACT Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has VA primary care provider for heart failure care
  • Hospitalization or emergency department visit for treatment of HF within past 12 months. Hospital discharge must be at least one month prior to study enrollment.
  • Hospitalization diagnoses may include: acute myocardial infarction (MI) or acute coronary syndrome with LV dysfunction (EF \<40%); status post coronary bypass graft surgery with LV dysfunction (EF \< 40%)
  • Documented heart failure (systolic or diastolic dysfunction) by echocardiogram or physician diagnosis and Stage C heart failure
  • years of age or older
  • Read and speak English
  • Have telephone access

You may not qualify if:

  • Patients will be excluded if they meet any of these criteria:
  • Are unable to give written informed consent
  • Have had a major acute medical problem (e.g., stroke, acute MI, CABG, or percutaneous intervention), or are considered medically unstable within the prior month
  • Have a history of severe pulmonary disease, renal disease requiring dialysis, severe hepatic disease, severe aortic or mitral stenosis, constrictive pericarditis, or cardiac transplant
  • Have a left ventricular assist device (LVAD)
  • Have a bi-ventricular pacemaker or implantable cardioverter defibrillator (ICD) placement in the past 1 month
  • Have a life expectancy of less than 1 year
  • Have current acute psychiatric problems, active substance abuse or homelessness
  • Are participating in an ongoing clinical drug trial.
  • Enrolled in specialty HF care via the HF Program or telehealth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (2)

  • Riegel B, Moser DK, Rayens MK, Carlson B, Pressler SJ, Shively M, Albert NM, Armola RR, Evangelista L, Westlake C, Sethares K; Heart Failure Trialists Collaborators. Ethnic differences in quality of life in persons with heart failure. J Card Fail. 2008 Feb;14(1):41-7. doi: 10.1016/j.cardfail.2007.09.008.

    PMID: 18226772BACKGROUND

  • McKibbin CL, Shively M, Glaser D, Kodiath M, Kelly A, Bormann JE, Stepnowsky C, Smith T. Readiness to change in heart failure patients: Adaptation of a pain readiness to change measure. Clinical Gerontologist. 2007 Oct 1; 31(2):33-43.

    BACKGROUND

MeSH Terms

Conditions

Heart FailureHealth Behavior

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Nancy J Gardetto, PhD NP

    VASDHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

September 1, 2006

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 8, 2019

Record last verified: 2019-10

Locations

US(1)