Back to resultsEnhancing Heart Failure Self-Care
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telephone management plus a motivational intervention
telephone management with standard patient education
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring motivational therapy
Eligibility Criteria
Inclusion Criteria:
- Chronic heart failure, hospitalized for heart failure or hospitalized for heart failure within the past 30 days, speak and read English
Exclusion Criteria:
- Severe renal failure requiring dialysis, HIV-AIDS, psychosis, uncorrected hearing loss
Sites / Locations
- Christiana Care Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Telephone management plus a motivational intervention
Telephone management with standard patient education
Outcomes
Primary Outcome Measures
To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in HF disease management.
Secondary Outcome Measures
Full Information
NCT ID
NCT00526773
First Posted
September 5, 2007
Last Updated
October 11, 2010
Sponsor
Christiana Care Health Services
1. Study Identification
Unique Protocol Identification Number
NCT00526773
Brief Title
Enhancing Heart Failure Self-Care
Official Title
Enhancing Heart Failure Self-Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Christiana Care Health Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in an existing heart failure (HF) disease management program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
motivational therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Telephone management plus a motivational intervention
Arm Title
2
Arm Type
Other
Arm Description
Telephone management with standard patient education
Intervention Type
Other
Intervention Name(s)
telephone management plus a motivational intervention
Intervention Description
heart failure intervention
Intervention Type
Other
Intervention Name(s)
telephone management with standard patient education
Intervention Description
heart failure intervention
Primary Outcome Measure Information:
Title
To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in HF disease management.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic heart failure, hospitalized for heart failure or hospitalized for heart failure within the past 30 days, speak and read English
Exclusion Criteria:
Severe renal failure requiring dialysis, HIV-AIDS, psychosis, uncorrected hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Reigel, DNSc, RN, CS, FAAN
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Enhancing Heart Failure Self-Care
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