NCT01049308

Brief Summary

We assessed the prevalence of cognitive/memory problems in veteran patients with heart failure, and evaluated its relationship to medication compliance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

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

January 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
Last Updated

April 28, 2015

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

January 12, 2010

Results QC Date

October 6, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

heart failurecognitive disordersmedication adherencepatient readmissions

Outcome Measures

Primary Outcomes (1)

  • SLUMS Scores

    SLUMS (Saint Louis University Mental Status) exam is a validated screening test for cognitive impairment (CI) consisting of 30-point interview scale. SLUMS is considered positive for mild CI if the score is \<27 in a person with a high school diploma or \<25 in a person who did not complete high school. SLUMS screening is considered positive for severe impairment consistent with dementia if the score is \<21 for persons with a high school diploma and \<20 for persons who did not complete high school.

    baseline collection

Secondary Outcomes (1)

  • Medication Adherence

    30 days

Study Arms (1)

Heart Failure

veteran population with documented heart failure

Eligibility Criteria

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

veteran patients enrolled in outpatient heart failure clinic

You may qualify if:

  • Patients with established diagnosis of clinical heart failure
  • English-speaking
  • Able to provide informed consent
  • Able to participate in cognitive function testing
  • Age over 18

You may not qualify if:

  • Life expectancy \< 6 months
  • Documented dementia requiring a caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California, 92357, United States

Location

Related Publications (1)

  • Hawkins LA, Kilian S, Firek A, Kashner TM, Firek CJ, Silvet H. Cognitive impairment and medication adherence in outpatients with heart failure. Heart Lung. 2012 Nov-Dec;41(6):572-82. doi: 10.1016/j.hrtlng.2012.06.001. Epub 2012 Jul 10.

MeSH Terms

Conditions

Heart FailureCognition DisordersCognitive DysfunctionMedication Adherence

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNeurocognitive DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr Helme Silvet
Organization
VA Loma Linda Healthcare System

Study Officials

  • Helme Silvet, MD

    VA Loma Linda Healthcare System, Loma Linda, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 14, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 28, 2015

Results First Posted

November 24, 2014

Record last verified: 2014-08

Locations