NCT00018005

Brief Summary

This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
902

participants targeted

Target at P50-P75 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Jun 2001

Typical duration for phase_3 cardiovascular-diseases

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

Study Start

First participant enrolled

June 1, 2001

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

June 26, 2001

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

First QC Date

June 26, 2001

Last Update Submit

October 19, 2012

Conditions

Cardiovascular DiseasesHeart DiseasesHeart Failure, Congestive

Keywords

Heart FailureSelf-ManagementBehavioral Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • Time until all-cause death or heart-failure hospitalization

    This is a composite outcome, measuring time from randomization to occurrence of death due to any cause or a hospitalization that is adjudicated to be due to heart-failure, among participants who experience either (or both) of these events. Only the first occurrence of either of these events is considered.

    Measured over the two years of study follow-up.

Secondary Outcomes (4)

  • Progression of heart failure

    Measured over the two years of study follow-up

  • Quality of life

    Measured over the two years of study follow-up

  • Health care costs

    Measured over the two years of study follow-up

  • Time until all-cause death or all-cause hospitalization

    Measured over the two years of study follow-up

Interventions

Self-ManagementBEHAVIORAL

18 in-person group sessions providing self-management training.

attention controlOTHER

18 educational mailings follow by a a telephone call.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • NYHA classification of II or III
  • LVEF of 40% or less

You may not qualify if:

  • Uncertain 12-month prognosis
  • Potential cardiac transplant within 1 year of study entry
  • Severe aortic stenosis
  • Uncontrolled ventricular tachycardia
  • Non-cardiac causes of heart failure symptoms (i.e., peripheral vascular disease, chronic obstructive pulmonary disease, and arthritis)
  • Major psychiatric co-morbidity
  • Unstable angina, myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 1 month prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush-Presbyterian-St. Lukes Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

  • Doukky R, Mangla A, Ibrahim Z, Poulin MF, Avery E, Collado FM, Kaplan J, Richardson D, Powell LH. Impact of Physical Inactivity on Mortality in Patients With Heart Failure. Am J Cardiol. 2016 Apr 1;117(7):1135-43. doi: 10.1016/j.amjcard.2015.12.060. Epub 2016 Jan 18.

    PMID: 26853954DERIVED

  • Doukky R, Avery E, Mangla A, Collado FM, Ibrahim Z, Poulin MF, Richardson D, Powell LH. Impact of Dietary Sodium Restriction on Heart Failure Outcomes. JACC Heart Fail. 2016 Jan;4(1):24-35. doi: 10.1016/j.jchf.2015.08.007.

    PMID: 26738949DERIVED

  • 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: 20858878DERIVED

  • 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: 18760125DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHeart Failure

Interventions

Self-Management

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lynda H. Powell

    Rush-Presbyterian-St. Lukes Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair, Department Preventive Medicine

Study Record Dates

First Submitted

June 26, 2001

First Posted

June 26, 2001

Study Start

June 1, 2001

Study Completion

June 1, 2007

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

US(1)