NCT01064765

Brief Summary

This study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

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

September 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

2.5 years

First QC Date

February 3, 2010

Last Update Submit

September 4, 2013

Conditions

Heart Failure

Keywords

Heart failureSelf managementcognitive dysfunctionSelf management of heart failure

Outcome Measures

Primary Outcomes (1)

  • Self-management of heart failure as measured by the Self-Care in Heart Failure Index

    at time of enrollment

Secondary Outcomes (1)

  • Duration of hospitalization(s)

    90 days after enrollment

Study Arms (1)

Heart failure

Outpatients with heart failure, age 75 or less, left ventricular ejection fraction 40% or less, english speaking with no known dementia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with history of heart failure 6 months or more meeting inclusion criteria recruited from outpatient clinic who receiving routine care for their heart failure

You may qualify if:

  • years of age or less
  • ejection fraction 40% or less
  • heart failure 6 months or more
  • English speaking
  • no known dementia
  • no active substance abuse
  • presence of caregiver/support

You may not qualify if:

  • neurologic disorders potentially causing cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Heart FailureCognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Savitri E. Fedson, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 8, 2010

Study Start

September 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)