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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date January 12, 2010
First Posted Date January 14, 2010
Results First Submitted Date October 6, 2014
Results First Posted Date November 24, 2014
Last Update Posted Date April 28, 2015
Study Start Date February 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2014)
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.
Original Primary Outcome Measures
 (submitted: January 13, 2010)
SLUMS scores (screening test for cognitive impairment) [ Time Frame: baseline collection ]
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2014)
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.
Original Secondary Outcome Measures
 (submitted: January 13, 2010)
  • association of cognitive impairment with medication adherence [ Time Frame: one month ]
  • qualitative description of cognitive impairment based on advanced psychometric testing [ Time Frame: baseline collection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population veteran patients enrolled in outpatient heart failure clinic
Condition
  • Heart Failure
  • Cognition Disorders
Intervention Not Provided
Study Groups/Cohorts Heart Failure
veteran population with documented heart failure
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 13, 2010)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01049308
Other Study ID Numbers RRP 09-166
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Original Responsible Party Silvet, Helme - Principal Investigator, Department of Veterans Affairs
Current Study Sponsor US Department of Veterans Affairs
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Helme Silvet, MD VA Loma Linda Healthcare System, Loma Linda, CA
PRS Account VA Office of Research and Development
Verification Date August 2014