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Cognitive Problems in Veterans With Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01049308
First received: January 12, 2010
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

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


Condition
Heart Failure
Cognition Disorders

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • SLUMS Scores [ Time Frame: baseline collection ] [ Designated as safety issue: No ]
    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:
  • Medication Adherence [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart Failure
veteran population with documented heart failure

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

veteran patients enrolled in outpatient heart failure clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049308

Locations
United States, California
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357
Sponsors and Collaborators
Investigators
Principal Investigator: Helme Silvet, MD VA Medical Center, Loma Linda
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01049308     History of Changes
Other Study ID Numbers: RRP 09-166
Study First Received: January 12, 2010
Results First Received: October 6, 2014
Last Updated: November 20, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
heart failure
cognitive disorders
medication adherence
patient readmissions

Additional relevant MeSH terms:
Cognition Disorders
Heart Failure
Cardiovascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Heart Diseases
Mental Disorders

ClinicalTrials.gov processed this record on November 25, 2014