Self-management and Cognitive Function in Adults With Heart Failure

Heart Failure Clinical Trial

— Heart ABC  

Official title:

Cognitive Impairment and Self-management in Adults With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461629
• Other study ID #: 10217650
• Secondary ID: 10217650
• Status: Completed
• Phase: N/A
• First received: October 26, 2011
• Last updated: April 6, 2016
• Start date: June 2010

Study information

• Verified date: April 2016
• Source: Kent State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Disease
• Cognition Disorders
• Cognitive Impairment
• Heart Diseases
• Heart Failure

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Kent State University	Case Western Reserve University, Summa Health System, University Hospital Case Medical Center

Country where clinical trial is conducted

United States,