Self-management and Cognitive Function in Adults With Heart Failure

NCT ID: NCT01461629

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Brief Summary

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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?

Detailed Description

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Conditions

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Cognitive Impairment Cardiac Disease Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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heart failure

left systolic heart failure (EF \</= 40%)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Summa Health System

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role collaborator

Kent State University

OTHER

Sponsor Role lead

Responsible Party

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Tony Vehovec

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Summa Health System

Akron, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34581712 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30190041 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27895069 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25576680 (View on PubMed)

Other Identifiers

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10217650

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10217650

Identifier Type: -

Identifier Source: org_study_id

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