Trial Outcomes & Findings for Cognitive Problems in Veterans With Heart Failure (NCT NCT01049308)
NCT ID: NCT01049308
Last Updated: 2015-04-28
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
300 participants
Primary outcome timeframe
baseline collection
Results posted on
2015-04-28
Participant Flow
Participant milestones
| Measure |
Heart Failure
veteran population with documented heart failure
|
|---|---|
|
Evaluation of Cognitive Impairment
STARTED
|
251
|
|
Evaluation of Cognitive Impairment
COMPLETED
|
251
|
|
Evaluation of Cognitive Impairment
NOT COMPLETED
|
0
|
|
Pill Counts
STARTED
|
251
|
|
Pill Counts
COMPLETED
|
168
|
|
Pill Counts
NOT COMPLETED
|
83
|
Reasons for withdrawal
| Measure |
Heart Failure
veteran population with documented heart failure
|
|---|---|
|
Pill Counts
Withdrawal by Subject
|
83
|
Baseline Characteristics
Cognitive Problems in Veterans With Heart Failure
Baseline characteristics by cohort
| Measure |
Group 1
n=251 Participants
veteran population with documented heart failure
|
|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
247 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
180 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=5 Participants
|
|
Living arrangement
Live alone
|
68 participants
n=5 Participants
|
|
Living arrangement
Live with spouse/partner
|
142 participants
n=5 Participants
|
|
Living arrangement
Live with children
|
17 participants
n=5 Participants
|
|
Living arrangement
Other
|
22 participants
n=5 Participants
|
|
Living arrangement
Not reported
|
2 participants
n=5 Participants
|
|
education
Less than high school
|
25 participants
n=5 Participants
|
|
education
High school diploma
|
60 participants
n=5 Participants
|
|
education
Some college
|
103 participants
n=5 Participants
|
|
education
College degree or above
|
60 participants
n=5 Participants
|
|
education
Not reported/unknown
|
3 participants
n=5 Participants
|
|
self-perceived financial status
Does not affect ability to care for health
|
111 participants
n=5 Participants
|
|
self-perceived financial status
Affects ability to care for health
|
110 participants
n=5 Participants
|
|
self-perceived financial status
Not reported/unknown
|
30 participants
n=5 Participants
|
|
Diabetes (I or II)
Have diagnosis
|
134 participants
n=5 Participants
|
|
Diabetes (I or II)
Do not have diagnosis
|
117 participants
n=5 Participants
|
|
Coronary Artery Disease
Have diagnosis
|
160 participants
n=5 Participants
|
|
Coronary Artery Disease
Do not have diagnosis
|
91 participants
n=5 Participants
|
|
Hypertension
Have diagnosis
|
193 participants
n=5 Participants
|
|
Hypertension
Do not have diagnosis
|
58 participants
n=5 Participants
|
|
Obstructive sleep apnea
Have diagnosis
|
68 participants
n=5 Participants
|
|
Obstructive sleep apnea
Do not have diagnosis
|
183 participants
n=5 Participants
|
|
History of atrial fibrillation
Yes
|
82 participants
n=5 Participants
|
|
History of atrial fibrillation
No
|
169 participants
n=5 Participants
|
|
History of stroke
Yes
|
26 participants
n=5 Participants
|
|
History of stroke
No
|
225 participants
n=5 Participants
|
|
Systolic blood pressure
|
125.8 mm hG
STANDARD_DEVIATION 19.67 • n=5 Participants
|
|
Thiamine level
|
169 nmol/L
STANDARD_DEVIATION 95.60 • n=5 Participants
|
|
Vitamin B12 level
|
556.8 pg/mL
STANDARD_DEVIATION 298.26 • n=5 Participants
|
|
Hemoglobin level
|
13.6 g/dL
STANDARD_DEVIATION 2.19 • n=5 Participants
|
|
Serum creatinine level
|
1.59 mg/dL
STANDARD_DEVIATION 1.84 • n=5 Participants
|
|
Thyroid-stimulating hormone
|
2.99 uiU/mL
STANDARD_DEVIATION 4.39 • n=5 Participants
|
|
Brain natriuretic peptide level
|
274.7 pg/mL
STANDARD_DEVIATION 497 • n=5 Participants
|
|
Hemoglobin A1c
|
6.8 %
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Heart Failure duration
Less than 1 year
|
22 participants
n=5 Participants
|
|
Heart Failure duration
1-5 years
|
104 participants
n=5 Participants
|
|
Heart Failure duration
Greater than 5 years
|
123 participants
n=5 Participants
|
|
Heart Failure duration
Not reported/unknown
|
2 participants
n=5 Participants
|
|
Heart failure cause
Ischemic
|
131 participants
n=5 Participants
|
|
Heart failure cause
Non-ischemic
|
107 participants
n=5 Participants
|
|
Heart failure cause
Not reported/unknown
|
13 participants
n=5 Participants
|
|
Left ventricular ejection fraction
>40%
|
85 participants
n=5 Participants
|
|
Left ventricular ejection fraction
<=40%
|
164 participants
n=5 Participants
|
|
Left ventricular ejection fraction
Not reported/unknown
|
2 participants
n=5 Participants
|
|
Left ventricular ejection fraction
|
37.5 %
STANDARD_DEVIATION 16.90 • n=5 Participants
|
|
History of depression
Yes
|
76 participants
n=5 Participants
|
|
History of depression
No
|
174 participants
n=5 Participants
|
|
History of depression
Unknown/not reported
|
1 participants
n=5 Participants
|
|
Geriatric Depression Scale
|
13.3 scores on a scale
STANDARD_DEVIATION 3.80 • n=5 Participants
|
|
History of PTSD
Yes
|
47 participants
n=5 Participants
|
|
History of PTSD
No
|
201 participants
n=5 Participants
|
|
History of PTSD
Unknown/not reported
|
3 participants
n=5 Participants
|
|
Tobacco use
Never smoked
|
47 participants
n=5 Participants
|
|
Tobacco use
Former smoker
|
154 participants
n=5 Participants
|
|
Tobacco use
Current smoker
|
47 participants
n=5 Participants
|
|
Tobacco use
Unknown/not reported
|
3 participants
n=5 Participants
|
|
Alcohol use
Never
|
80 participants
n=5 Participants
|
|
Alcohol use
Former use
|
83 participants
n=5 Participants
|
|
Alcohol use
Current use less than or equal to 3 drinks/week
|
59 participants
n=5 Participants
|
|
Alcohol use
Current use greater than 3 drinks per week
|
29 participants
n=5 Participants
|
|
Marijuana use
Never
|
156 participants
n=5 Participants
|
|
Marijuana use
Past use
|
78 participants
n=5 Participants
|
|
Marijuana use
Current use
|
14 participants
n=5 Participants
|
|
Marijuana use
Unknown/not reported
|
3 participants
n=5 Participants
|
|
Other illicit substance use
Never
|
190 participants
n=5 Participants
|
|
Other illicit substance use
Past use
|
57 participants
n=5 Participants
|
|
Other illicit substance use
Current use
|
1 participants
n=5 Participants
|
|
Other illicit substance use
Unknown/not reported
|
3 participants
n=5 Participants
|
|
Received treatment in heart failure specialty clinic
Yes
|
143 participants
n=5 Participants
|
|
Received treatment in heart failure specialty clinic
No
|
108 participants
n=5 Participants
|
|
Prescribing providers
|
5.4 prescribing providers
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Hospitalizations in past year
|
.58 hospitalizations
STANDARD_DEVIATION 1.12 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline collectionSLUMS (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.
Outcome measures
| Measure |
Heart Failure
n=251 Participants
veteran population with documented heart failure
|
Mild CI
veteran population with documented heart failure with mild cognitive impairment on SLUMS screening test who finished 30-day pill counts
|
Severe CI
veteran population with documented heart failure with severe cognitive impairment (dementia) on SLUMS screening test who finished 30-day pill counts
|
|---|---|---|---|
|
SLUMS Scores
|
24.39 scores on a scale
Standard Deviation 4
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 daysTo 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.
Outcome measures
| Measure |
Heart Failure
n=82 Participants
veteran population with documented heart failure
|
Mild CI
n=66 Participants
veteran population with documented heart failure with mild cognitive impairment on SLUMS screening test who finished 30-day pill counts
|
Severe CI
n=20 Participants
veteran population with documented heart failure with severe cognitive impairment (dementia) on SLUMS screening test who finished 30-day pill counts
|
|---|---|---|---|
|
Medication Adherence
|
81.1 percentage of adherence
Interval 77.1 to 85.0
|
74.1 percentage of adherence
Interval 69.6 to 78.5
|
74.0 percentage of adherence
Interval 65.9 to 82.1
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place