NCT01461629

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. 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. 2.How are these relationships altered when adjusting for medical, demographic, and psychosocial factors?
  3. 3.What are the relationships among degree of cognitive impairment, quality self-management, health status, and health service use?

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

4.8 years

First QC Date

October 26, 2011

Last Update Submit

April 6, 2016

Conditions

Cognitive ImpairmentCardiac DiseaseHeart Failure

Keywords

cognitive impairmentcognitive functionhospitalizationself-managementcardiac diseaseheart failure

Study Arms (1)

heart failure

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

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50-85 years of age, documented diagnosis of systolic heart failure (EF \</= 35%) at least 12 months prior to enrollment

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summa Health System

Akron, Ohio, 44309, United States

Location

Related Publications (4)

  • 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.

    PMID: 34581712DERIVED

  • 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.

    PMID: 30190041DERIVED

  • 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.

    PMID: 27895069DERIVED

  • 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.

    PMID: 25576680DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary sodium

MeSH Terms

Conditions

Cognitive DysfunctionHeart DiseasesHeart Failure

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 26, 2011

First Posted

October 28, 2011

Study Start

June 1, 2010

Primary Completion

April 1, 2015

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

US(1)