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History of Changes for Study: NCT01049308
Cognitive Problems in Veterans With Heart Failure
Latest version (submitted April 6, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 13, 2010 None (earliest Version on record)
2 June 28, 2010 Recruitment Status, Contacts/Locations and Study Status
3 December 7, 2010 Study Status
4 June 30, 2011 Recruitment Status, Study Status, Contacts/Locations and Study Description
5 January 27, 2012 Sponsor/Collaborators and Study Status
6 April 23, 2012 Groups and Interventions and Study Status
7 June 4, 2012 Outcome Measures, Study Status and Study Design
8 August 1, 2012 Study Status
9 January 24, 2013 Study Status
10 April 18, 2013 References and Study Status
11 August 18, 2014 Study Status
12 November 20, 2014 Outcome Measures, Study Status, Results, Groups and Interventions and Study Description
13 April 6, 2015 Contacts/Locations and Study Status
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Study NCT01049308
Submitted Date:  January 13, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: RRP 09-166
Brief Title: Cognitive Problems in Veterans With Heart Failure
Official Title: Cognitive Impairment as a Risk for the Admission-Readmission Cycle Seen in Veterans With Heart Failure: Closing the Adherence Gap
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2010
Overall Status: Not yet recruiting
Study Start: February 2010
Primary Completion: December 2010 [Anticipated]
Study Completion: January 2011 [Anticipated]
First Submitted: January 12, 2010
First Submitted that
Met QC Criteria:
January 13, 2010
First Posted: January 14, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 13, 2010
Last Update Posted: January 14, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: US Department of Veterans Affairs
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: We plan to assess the prevalence of cognitive/memory problems in veteran patients with heart failure, and evaluate 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, and the CHF QUERI's 2008 Strategic Plan ranks lowering readmission rates as the highest in priority of clinical issues to be addressed.

Non-adherence to prescribed medication and self-care regimens in patients with heart failure is well known to lead to increased morbidity, including readmissions. Despite multiple modalities of patient education there remains a failure on the part of many patients in our outpatient HF clinic to adhere to even a carefully individualized plan of care. We have termed this care deficit the "patient adherence gap".

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. There are also no published data sufficiently evaluating the link between CI and adherence or the link between CI and readmissions in heart failure populations.

To address this need, we have designed a descriptive cross-sectional study as a pre-implementation effort. We hypothesize that the presence of CI negatively impacts adherence and contributes to the patient adherence gap, which in turn results in increased readmissions for HF. Goals of this pilot study are to: (1) evaluate the association of CI with adherence (measured by compliance with medications); (2) determine the prevalence of CI in veterans with all-cause HF in an outpatient setting; (3) quantitatively describe the extent of CI in this population; (4) qualitatively describe neuropsychological domains affected by CI.

To accomplish these goals, all consenting eligible outpatients in our VA HF clinic will undergo a simple screening test for CI (SLUMS). We will also interview the patients to collect demographic and clinical data, and to rate them on the geriatric depression scale. If the subjects screen positive for CI, they will undergo further evaluation by a battery of neuropsychological tests. Adherence will be evaluated by a direct 30 day pill count, a brief questionnaire measuring intentional nonadherence, and a review of pharmacy refill records. We will follow patients after the 12-month study period to collect data on hospital readmissions.

Results from our study will test the feasibility and utility of screening for CI in outpatient HF population, using simple and cost-effective tools. It will also provide valuable data to support our future intervention trial assessing the impact of CI intervention on outcomes, such as improved adherence and reduced admissions.

Open or close this module Conditions
Conditions: Heart Failure
Cognition Disorders
Keywords: heart failure
cognitive disorders
medication adherence
patient readmissions
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 300 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
1
veteran population with documented heart failure
Open or close this module Outcome Measures
Primary Outcome Measures:
1. SLUMS scores (screening test for cognitive impairment)
[ Time Frame: baseline collection ]

Secondary Outcome Measures:
1. association of cognitive impairment with medication adherence
[ Time Frame: one month ]

2. qualitative description of cognitive impairment based on advanced psychometric testing
[ Time Frame: baseline collection ]

Open or close this module Eligibility
Study Population: veteran patients enrolled in outpatient heart failure clinic
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Helme Silvet, MD
Telephone: (909) 583-6097
Email: Helme.Silvet@va.gov
Central Contact Backup: Lee Ann Hawkins, NP
Telephone: (909) 825-7084 Ext. 2685
Email: Leeann.Hawkins@va.gov
Study Officials: Helme Silvet, MD
Principal Investigator
VA Medical Center, Loma Linda
Locations: United States, California
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357
Contact:Contact: Helme Silvet, MD 909-583-6097 Helme.Silvet@va.gov
Contact:Contact: Lee Ann Hawkins, NP (909) 825-7084 Ext. 2685 Leeann.Hawkins@va.gov
Contact:Principal Investigator: Helme Silvet, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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