Cognition Disorders, Heart Failure
Conditions
Keywords
heart failure, cognitive disorders, medication adherence, patient readmissions
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.
Interventions
None listed
Sponsors
US Department of Veterans Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 veteran population with documented heart failure | 251 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Pill Counts | Withdrawal by Subject | 83 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 9.8 |
| Alcohol use Current use greater than 3 drinks per week | 29 participants |
| Alcohol use Current use less than or equal to 3 drinks/week | 59 participants |
| Alcohol use Former use | 83 participants |
| Alcohol use Never | 80 participants |
| Brain natriuretic peptide level | 274.7 pg/mL STANDARD_DEVIATION 497 |
| Coronary Artery Disease Do not have diagnosis | 91 participants |
| Coronary Artery Disease Have diagnosis | 160 participants |
| Diabetes (I or II) Do not have diagnosis | 117 participants |
| Diabetes (I or II) Have diagnosis | 134 participants |
| education College degree or above | 60 participants |
| education High school diploma | 60 participants |
| education Less than high school | 25 participants |
| education Not reported/unknown | 3 participants |
| education Some college | 103 participants |
| Geriatric Depression Scale | 13.3 scores on a scale STANDARD_DEVIATION 3.8 |
| Heart failure cause Ischemic | 131 participants |
| Heart failure cause Non-ischemic | 107 participants |
| Heart failure cause Not reported/unknown | 13 participants |
| Heart Failure duration 1-5 years | 104 participants |
| Heart Failure duration Greater than 5 years | 123 participants |
| Heart Failure duration Less than 1 year | 22 participants |
| Heart Failure duration Not reported/unknown | 2 participants |
| Hemoglobin A1c | 6.8 % STANDARD_DEVIATION 1.5 |
| Hemoglobin level | 13.6 g/dL STANDARD_DEVIATION 2.19 |
| History of atrial fibrillation No | 169 participants |
| History of atrial fibrillation Yes | 82 participants |
| History of depression No | 174 participants |
| History of depression Unknown/not reported | 1 participants |
| History of depression Yes | 76 participants |
| History of PTSD No | 201 participants |
| History of PTSD Unknown/not reported | 3 participants |
| History of PTSD Yes | 47 participants |
| History of stroke No | 225 participants |
| History of stroke Yes | 26 participants |
| Hospitalizations in past year | .58 hospitalizations STANDARD_DEVIATION 1.12 |
| Hypertension Do not have diagnosis | 58 participants |
| Hypertension Have diagnosis | 193 participants |
| Left ventricular ejection fraction <=40% | 164 participants |
| Left ventricular ejection fraction >40% | 85 participants |
| Left ventricular ejection fraction Not reported/unknown | 2 participants |
| Left ventricular ejection fraction | 37.5 % STANDARD_DEVIATION 16.9 |
| Living arrangement Live alone | 68 participants |
| Living arrangement Live with children | 17 participants |
| Living arrangement Live with spouse/partner | 142 participants |
| Living arrangement Not reported | 2 participants |
| Living arrangement Other | 22 participants |
| Marijuana use Current use | 14 participants |
| Marijuana use Never | 156 participants |
| Marijuana use Past use | 78 participants |
| Marijuana use Unknown/not reported | 3 participants |
| Obstructive sleep apnea Do not have diagnosis | 183 participants |
| Obstructive sleep apnea Have diagnosis | 68 participants |
| Other illicit substance use Current use | 1 participants |
| Other illicit substance use Never | 190 participants |
| Other illicit substance use Past use | 57 participants |
| Other illicit substance use Unknown/not reported | 3 participants |
| Prescribing providers | 5.4 prescribing providers STANDARD_DEVIATION 2.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 37 Participants |
| Race (NIH/OMB) White | 180 Participants |
| Received treatment in heart failure specialty clinic No | 108 participants |
| Received treatment in heart failure specialty clinic Yes | 143 participants |
| self-perceived financial status Affects ability to care for health | 110 participants |
| self-perceived financial status Does not affect ability to care for health | 111 participants |
| self-perceived financial status Not reported/unknown | 30 participants |
| Serum creatinine level | 1.59 mg/dL STANDARD_DEVIATION 1.84 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 247 Participants |
| Systolic blood pressure | 125.8 mm hG STANDARD_DEVIATION 19.67 |
| Thiamine level | 169 nmol/L STANDARD_DEVIATION 95.6 |
| Thyroid-stimulating hormone | 2.99 uiU/mL STANDARD_DEVIATION 4.39 |
| Tobacco use Current smoker | 47 participants |
| Tobacco use Former smoker | 154 participants |
| Tobacco use Never smoked | 47 participants |
| Tobacco use Unknown/not reported | 3 participants |
| Vitamin B12 level | 556.8 pg/mL STANDARD_DEVIATION 298.26 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 251 |
| serious Total, serious adverse events | 0 / 251 |
Outcome results
Primary
SLUMS Scores
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heart Failure | SLUMS Scores | 24.39 scores on a scale | Standard Deviation 4 |
Comparison: Descriptive data to describe prevalence of cognitive impairment in outpatient veterans with chronic heart failure
Secondary
Medication Adherence
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Heart Failure | Medication Adherence | 81.1 percentage of adherence |
| Mild CI | Medication Adherence | 74.1 percentage of adherence |
| Severe CI | Medication Adherence | 74.0 percentage of adherence |