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Cognitive Problems in Veterans With Heart Failure

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ClinicalTrials.gov Identifier: NCT01049308
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : November 24, 2014
Last Update Posted : April 28, 2015
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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

Condition or disease
Heart Failure Cognition Disorders

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Impairment as a Risk for the Admission-Readmission Cycle Seen in Veterans With Heart Failure: Closing the Adherence Gap
Study Start Date : February 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Heart Failure
veteran population with documented heart failure

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Medication Adherence [ Time Frame: 30 days ]
    To capture both overtaking and undertaking medication, a "delta" was determined for each medication by computing the absolute difference between the number of pills taken and the number prescribed over the 30-day period. The delta values for each medication were summed for each individual subject, divided by the total number of pills prescribed, subtracted from 1, and finally multiplied by 100 to obtain an adherence score expressed as a percentage.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
veteran patients enrolled in outpatient heart failure clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049308

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United States, California
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Helme Silvet, MD VA Loma Linda Healthcare System, Loma Linda, CA
Publications of Results:
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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01049308    
Other Study ID Numbers: RRP 09-166
First Posted: January 14, 2010    Key Record Dates
Results First Posted: November 24, 2014
Last Update Posted: April 28, 2015
Last Verified: August 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
heart failure
cognitive disorders
medication adherence
patient readmissions
Additional relevant MeSH terms:
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Heart Failure
Cognition Disorders
Heart Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders