Cognitive Problems in Veterans With Heart Failure
|ClinicalTrials.gov Identifier: NCT01049308|
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : November 24, 2014
Last Update Posted : April 28, 2015
|Condition or disease|
|Heart Failure Cognition Disorders|
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.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|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|
veteran population with documented heart failure
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049308
|United States, California|
|VA Loma Linda Healthcare System, Loma Linda, CA|
|Loma Linda, California, United States, 92357|
|Principal Investigator:||Helme Silvet, MD||VA Loma Linda Healthcare System, Loma Linda, CA|