Clinical trial NCT01049308: Cognitive Problems in Veterans With Heart Failure
Official title: Cognitive Impairment as a Risk for the Admission-Readmission Cycle Seen in Veterans With Heart Failure: Closing the Adherence Gap
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cognition Disorders
Keywords: heart failure
cognitive disorders
medication adherence
patient readmissions
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-01-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: veteran patients enrolled in outpatient heart failure clinic

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.

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

Primary outcomes:
measure: SLUMS Scores
timeFrame: baseline collection
Secondary outcomes:
measure: Medication Adherence
timeFrame: 30 days
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System, Loma Linda, CA
state: California
Study officials:
affiliation: VA Loma Linda Healthcare System, Loma Linda, CA
name: Helme Silvet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.