Clinical trial NCT01461629: Self-management and Cognitive Function in Adults With Heart Failure
Official title: Cognitive Impairment and Self-management in Adults With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Cardiac Disease
Heart Failure
Keywords: cognitive impairment
cognitive function
hospitalization
self-management
cardiac disease
heart failure
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: Summa Health System
name: Case Western Reserve University
name: University Hospitals Cleveland Medical Center
First posted: 2011-10-28
Enrollment: 372
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50-85 years of age, documented diagnosis of systolic heart failure (EF \</= 35%) at least 12 months prior to enrollment

Brief summary: The purpose of this study is to assess the relationship between cognitive impairment, patient self-management, health, and health service use in adults with heart failure (NYHA Class 2 and 3). The research questions are:

1. How is cognitive impairment (memory, attention, global and executive function) related to various aspects of impaired self-management (knowledge of adherence, adherence to sodium restriction and medications, symptom monitoring of weight changes, and decision and action to seek care)?
2. How are these relationships altered when adjusting for medical, demographic, and psychosocial factors?
3. What are the relationships among degree of cognitive impairment, quality self-management, health status, and health service use?


Eligibility criteria: Inclusion Criteria:

* documented systolic heart failure
* NYHA class II, III of at least 6 months duration
* 50-85 years of age
* has a telephone (land line) or be willing to allow a telephone installed for duration of study

Exclusion Criteria:

* history of neurological disorder or injury
* moderate or severe head injury
* past or current history of severe psychiatric illness; specifically, psychotic disorders and bipolar disorder
* 5 year past or current history of alcohol or drug abuse
* history of learning disorder or developmental disability
* renal failure requiring dialysis
* history of sleep apnea
* current home telemonitoring program to assist w/ HF self-management
* cardiac surgery \< 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Health System
state: Ohio
Study officials:
References:
citation: Kuhn TA, Gathright EC, Dolansky MA, Gunstad J, Josephson R, Hughes JW. Health Literacy, Cognitive Function, and Mortality in Patients With Heart Failure. J Cardiovasc Nurs. 2022 Jan-Feb 01;37(1):50-55. doi: 10.1097/JCN.0000000000000855.
citation: Walter FA, Ede D, Hawkins MAW, Dolansky MA, Gunstad J, Josephson R, Moore SM, Hughes JW. Sleep quality and daytime sleepiness are not associated with cognition in heart failure. J Psychosom Res. 2018 Oct;113:100-106. doi: 10.1016/j.jpsychores.2018.08.003. Epub 2018 Aug 10.
citation: Dolansky MA, Hawkins MA, Schaefer JT, Sattar A, Gunstad J, Redle JD, Josephson R, Moore SM, Hughes JW. Association Between Poorer Cognitive Function and Reduced Objectively Monitored Medication Adherence in Patients With Heart Failure. Circ Heart Fail. 2016 Dec;9(12):e002475. doi: 10.1161/CIRCHEARTFAILURE.116.002475.
citation: Basuray A, Dolansky M, Josephson R, Sattar A, Grady EM, Vehovec A, Gunstad J, Redle J, Fang J, Hughes JW. Dietary sodium adherence is poor in chronic heart failure patients. J Card Fail. 2015 Apr;21(4):323-9. doi: 10.1016/j.cardfail.2014.12.016. Epub 2015 Jan 7.