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Cognitive Problems in Veterans With Heart Failure - NCT01049308-92357(Clinical Trial 465022)



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City:  Loma Linda
State:  
CA
Zip Code: 92357
Conditions: Heart Failure - Cognition Disorders
Purpose: We plan to assess the prevalence of cognitive/memory problems in veteran patients with heart failure, and evaluate its relationship to medication compliance.
Study summary: 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, and the CHF QUERI's 2008 Strategic Plan ranks lowering readmission rates as the highest in priority of clinical issues to be addressed. Non-adherence to prescribed medication and self-care regimens in patients with heart failure is well known to lead to increased morbidity, including readmissions. Despite multiple modalities of patient education there remains a failure on the part of many patients in our outpatient HF clinic to adhere to even a carefully individualized plan of care. We have termed this care deficit the "patient adherence gap". 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. There are also no published data sufficiently evaluating the link between CI and adherence or the link between CI and readmissions in heart failure populations. To address this need, we have designed a descriptive cross-sectional study as a pre-implementation effort. We hypothesize that the presence of CI negatively impacts adherence and contributes to the patient adherence gap, which in turn results in increased readmissions for HF. Goals of this pilot study are to: (1) evaluate the association of CI with adherence (measured by compliance with medications); (2) determine the prevalence of CI in veterans with all-cause HF in an outpatient setting; (3) quantitatively describe the extent of CI in this population; (4) qualitatively describe neuropsychological domains affected by CI. To accomplish these goals, all consenting eligible outpatients in our VA HF clinic will undergo a simple screening test for CI (SLUMS). We will also interview the patients to collect demographic and clinical data, and to rate them on the geriatric depression scale. If the subjects screen positive for CI, they will undergo further evaluation by a battery of neuropsychological tests. Adherence will be evaluated by a direct 30 day pill count, a brief questionnaire measuring intentional nonadherence, and a review of pharmacy refill records. We will follow patients after the 12-month study period to collect data on hospital readmissions. Results from our study will test the feasibility and utility of screening for CI in outpatient HF population, using simple and cost-effective tools. It will also provide valuable data to support our future intervention trial assessing the impact of CI intervention on outcomes, such as improved adherence and reduced admissions.
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
Study is available at: VA Medical Center, Loma Linda
Loma Linda, CA 92357
United States

Primary Contact:
Helme Silvet, MD
Email: Helme.Silvet@va.gov
Phone: 909-583-6097

Secondary Contact:
Chris Firek, BS
Email: chris.firek@va.gov
Phone: (909) 825-7084
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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