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Cognitive Problems in Veterans With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Heart Failure
Cognition Disorders
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Heart Failure
Hide Arm/Group Description veteran population with documented heart failure
Period Title: Evaluation of Cognitive Impairment
Started 251
Completed 251
Not Completed 0
Period Title: Pill Counts
Started 251
Completed 168
Not Completed 83
Reason Not Completed
Withdrawal by Subject             83
Arm/Group Title Group 1
Hide Arm/Group Description veteran population with documented heart failure
Overall Number of Baseline Participants 251
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 251 participants
66.4  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants
Female
4
   1.6%
Male
247
  98.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
34
  13.5%
White
180
  71.7%
More than one race
0
   0.0%
Unknown or Not Reported
37
  14.7%
Living arrangement  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Live alone 68
Live with spouse/partner 142
Live with children 17
Other 22
Not reported 2
education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Less than high school 25
High school diploma 60
Some college 103
College degree or above 60
Not reported/unknown 3
self-perceived financial status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Does not affect ability to care for health 111
Affects ability to care for health 110
Not reported/unknown 30
Diabetes (I or II)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Have diagnosis 134
Do not have diagnosis 117
Coronary Artery Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Have diagnosis 160
Do not have diagnosis 91
Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Have diagnosis 193
Do not have diagnosis 58
Obstructive sleep apnea  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Have diagnosis 68
Do not have diagnosis 183
History of atrial fibrillation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Yes 82
No 169
History of stroke  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Yes 26
No 225
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm hG
Number Analyzed 251 participants
125.8  (19.67)
Thiamine level  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 251 participants
169  (95.60)
Vitamin B12 level  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 251 participants
556.8  (298.26)
Hemoglobin level  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 251 participants
13.6  (2.19)
Serum creatinine level  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 251 participants
1.59  (1.84)
Thyroid-stimulating hormone  
Mean (Standard Deviation)
Unit of measure:  uiU/mL
Number Analyzed 251 participants
2.99  (4.39)
Brain natriuretic peptide level  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 251 participants
274.7  (497)
Hemoglobin A1c  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 251 participants
6.8  (1.5)
Heart Failure duration  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Less than 1 year 22
1-5 years 104
Greater than 5 years 123
Not reported/unknown 2
Heart failure cause  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Ischemic 131
Non-ischemic 107
Not reported/unknown 13
Left ventricular ejection fraction  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
>40% 85
<=40% 164
Not reported/unknown 2
Left ventricular ejection fraction  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 251 participants
37.5  (16.90)
History of depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Yes 76
No 174
Unknown/not reported 1
Geriatric Depression Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 251 participants
13.3  (3.80)
[1]
Measure Description: Geriatric Depression Scale (GDS) is a validated self-report measure consisting of 30 questions used to screen elderly people for depression. Cutoff scores are as follows: 0-9 normal, 10-19 mildly depressed, 20-30 severely depressed.
History of PTSD  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Yes 47
No 201
Unknown/not reported 3
Tobacco use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Never smoked 47
Former smoker 154
Current smoker 47
Unknown/not reported 3
Alcohol use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Never 80
Former use 83
Current use less than or equal to 3 drinks/week 59
Current use greater than 3 drinks per week 29
Marijuana use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Never 156
Past use 78
Current use 14
Unknown/not reported 3
Other illicit substance use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Never 190
Past use 57
Current use 1
Unknown/not reported 3
Received treatment in heart failure specialty clinic  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants
Yes 143
No 108
Prescribing providers  
Mean (Standard Deviation)
Unit of measure:  Prescribing providers
Number Analyzed 251 participants
5.4  (2.4)
Hospitalizations in past year  
Mean (Standard Deviation)
Unit of measure:  Hospitalizations
Number Analyzed 251 participants
.58  (1.12)
1.Primary Outcome
Title SLUMS Scores
Hide Description 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.
Time Frame baseline collection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Heart Failure
Hide Arm/Group Description:
veteran population with documented heart failure
Overall Number of Participants Analyzed 251
Mean (Standard Deviation)
Unit of Measure: scores on a scale
24.39  (4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Heart Failure
Comments Descriptive data to describe prevalence of cognitive impairment in outpatient veterans with chronic heart failure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 57.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Medication Adherence
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No CI Mild CI Severe CI
Hide Arm/Group Description:
veteran population with documented heart failure with no cognitive impairment on SLUMS screening test who finished 30-day pill counts
veteran population with documented heart failure with mild cognitive impairment on SLUMS screening test who finished 30-day pill counts
veteran population with documented heart failure with severe cognitive impairment (dementia) on SLUMS screening test who finished 30-day pill counts
Overall Number of Participants Analyzed 82 66 20
Mean (95% Confidence Interval)
Unit of Measure: percentage of adherence
81.1
(77.1 to 85.0)
74.1
(69.6 to 78.5)
74.0
(65.9 to 82.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description veteran population with documented heart failure
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/251 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   0/251 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Helme Silvet
Organization: VA Loma Linda Healthcare System
Phone: 9095836097
EMail: helme.silvet@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01049308    
Other Study ID Numbers: RRP 09-166
First Submitted: January 12, 2010
First Posted: January 14, 2010
Results First Submitted: October 6, 2014
Results First Posted: November 24, 2014
Last Update Posted: April 28, 2015