Skip to main content
Clinical Trials/NCT01049308
NCT01049308
Completed
Not Applicable

Cognitive Impairment as a Risk for the Admission-Readmission Cycle Seen in Veterans With Heart Failure: Closing the Adherence Gap

US Department of Veterans Affairs1 site in 1 country300 target enrollmentFebruary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
US Department of Veterans Affairs
Enrollment
300
Locations
1
Primary Endpoint
SLUMS Scores
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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

Detailed Description

Heart failure (HF) is a costly, chronic, and complex condition that impacts veterans' quality of life, morbidity, and mortality. In the VA population up to 20% of patients are readmitted for HF within 30 days. Non-adherence to prescribed medication and self-care regimens in patients with HF is known to lead to increased morbidity, including readmissions. Cognitive impairment (CI) has been shown to predict nonadherence in elderly people without HF, however, this link has not been studied in HF populations. In the non-veteran population, HF patients are known to have an increased prevalence of cognitive impairment (CI), however, no existing study has determined the extent and type of CI in veterans with HF. This pilot study was designed as a descriptive cross-sectional study as a pre-implementation effort with following goals: (1) determine the prevalence of CI in veterans with all-cause HF in an outpatient setting; (2) quantitatively describe the extent of CI in this population; (3) qualitatively describe neuropsychological domains affected by CI; (4) evaluate the association of CI with medication adherence and other clinical variables. All consenting eligible outpatients in our VA HF clinic underwent a simple screening test for CI (Saint Louis University Mental Status Exam). Demographic and clinical variables were collected by patient interviews and chartg reviews, and included Geriatric Depression Scale and questionnaires about medication-taking behaviors. All subjects were invited back for 30-day direct pill count of all their routinely prescribed medications. Subjects who screened positive for CI were invited back for a modified battery of neuropsychological tests to determine the cognitive domains affected. Subjects will also be followed after the 12-month study period to collect data on hospital readmissions.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
April 2011
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

SLUMS Scores

Time Frame: baseline collection

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.

Secondary Outcomes

  • Medication Adherence(30 days)

Study Sites (1)

Loading locations...

Similar Trials