Cognitive Problems in Veterans With Heart Failure

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01049308
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Duration (Months): 13.9
• Patients Per Site Per Month: 21.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Cognition Disorders

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 Design

• Study Type: Observational
• Actual Enrollment: 300 participants
• 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
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Heart Failure veteran population with documented heart failure

Outcome Measures

Primary Outcome Measures

1. SLUMS Scores [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.

Secondary Outcome Measures

1. Medication Adherence [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	VA Loma Linda Healthcare System, Loma Linda, CA	Loma Linda	California	United States	92357

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Helme Silvet, MD, VA Loma Linda Healthcare System, Loma Linda, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT01049308
• Other Study ID Numbers: RRP 09-166
• First Posted: Jan 14, 2010
• Last Update Posted: Apr 28, 2015
• Last Verified: Aug 1, 2014

• Keywords provided by US Department of Veterans Affairs: heart failure; cognitive disorders; medication adherence; patient readmissions
• Additional relevant MeSH terms: Heart Failure; Cognition Disorders

Study Results

Participant Flow

Arm/Group Title	Heart Failure
Arm/Group Description	veteran population with documented heart failure
Period Title: Evaluation of Cognitive Impairment
STARTED	251
COMPLETED	251
NOT COMPLETED	0
Period Title: Evaluation of Cognitive Impairment
STARTED	251
COMPLETED	168
NOT COMPLETED	83

Baseline Characteristics

Arm/Group Title	Group 1
Arm/Group Description	veteran population with documented heart failure
Overall Participants	251
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.4 (9.8)
Sex: Female, Male (Count of Participants)
Female	4 1.6%
Male	247 98.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	34 13.5%
White	180 71.7%
More than one race	0 0%
Unknown or Not Reported	37 14.7%
Living arrangement (participants) [Number]
Live alone	68 27.1%
Live with spouse/partner	142 56.6%
Live with children	17 6.8%
Other	22 8.8%
Not reported	2 0.8%
education (participants) [Number]
Less than high school	25 10%
High school diploma	60 23.9%
Some college	103 41%
College degree or above	60 23.9%
Not reported/unknown	3 1.2%
self-perceived financial status (participants) [Number]
Does not affect ability to care for health	111 44.2%
Affects ability to care for health	110 43.8%
Not reported/unknown	30 12%
Diabetes (I or II) (participants) [Number]
Have diagnosis	134 53.4%
Do not have diagnosis	117 46.6%
Coronary Artery Disease (participants) [Number]
Have diagnosis	160 63.7%
Do not have diagnosis	91 36.3%
Hypertension (participants) [Number]
Have diagnosis	193 76.9%
Do not have diagnosis	58 23.1%
Obstructive sleep apnea (participants) [Number]
Have diagnosis	68 27.1%
Do not have diagnosis	183 72.9%
History of atrial fibrillation (participants) [Number]
Yes	82 32.7%
No	169 67.3%
History of stroke (participants) [Number]
Yes	26 10.4%
No	225 89.6%
Systolic blood pressure (mm hG) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm hG]	125.8 (19.67)
Thiamine level (nmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nmol/L]	169 (95.60)
Vitamin B12 level (pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/mL]	556.8 (298.26)
Hemoglobin level (g/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dL]	13.6 (2.19)
Serum creatinine level (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	1.59 (1.84)
Thyroid-stimulating hormone (uiU/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [uiU/mL]	2.99 (4.39)
Brain natriuretic peptide level (pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/mL]	274.7 (497)
Hemoglobin A1c (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	6.8 (1.5)
Heart Failure duration (participants) [Number]
Less than 1 year	22 8.8%
1-5 years	104 41.4%
Greater than 5 years	123 49%
Not reported/unknown	2 0.8%
Heart failure cause (participants) [Number]
Ischemic	131 52.2%
Non-ischemic	107 42.6%
Not reported/unknown	13 5.2%
Left ventricular ejection fraction (participants) [Number]
>40%	85 33.9%
<=40%	164 65.3%
Not reported/unknown	2 0.8%
Left ventricular ejection fraction (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	37.5 (16.90)
History of depression (participants) [Number]
Yes	76 30.3%
No	174 69.3%
Unknown/not reported	1 0.4%
Geriatric Depression Scale (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	13.3 (3.80)
History of PTSD (participants) [Number]
Yes	47 18.7%
No	201 80.1%
Unknown/not reported	3 1.2%
Tobacco use (participants) [Number]
Never smoked	47 18.7%
Former smoker	154 61.4%
Current smoker	47 18.7%
Unknown/not reported	3 1.2%
Alcohol use (participants) [Number]
Never	80 31.9%
Former use	83 33.1%
Current use less than or equal to 3 drinks/week	59 23.5%
Current use greater than 3 drinks per week	29 11.6%
Marijuana use (participants) [Number]
Never	156 62.2%
Past use	78 31.1%
Current use	14 5.6%
Unknown/not reported	3 1.2%
Other illicit substance use (participants) [Number]
Never	190 75.7%
Past use	57 22.7%
Current use	1 0.4%
Unknown/not reported	3 1.2%
Received treatment in heart failure specialty clinic (participants) [Number]
Yes	143 57%
No	108 43%
Prescribing providers (prescribing providers) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [prescribing providers]	5.4 (2.4)
Hospitalizations in past year (hospitalizations) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hospitalizations]	.58 (1.12)

Outcome Measures

1. Primary Outcome

Title	SLUMS Scores
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Heart Failure
Arm/Group Description	veteran population with documented heart failure
Measure Participants	251
Mean (Standard Deviation) [scores on a scale]	24.39 (4)

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage
	Estimated Value	57.6
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Medication Adherence
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No CI	Mild CI	Severe CI
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
Measure Participants	82	66	20
Mean (95% Confidence Interval) [percentage of adherence]	81.1	74.1	74.0

Adverse Events

Arm/Group Title	Group 1
Arm/Group Description	veteran population with documented heart failure
All Cause Mortality
	Group 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/251 (0%)
Other (Not Including Serious) Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/251 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.