- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526773
Enhancing Heart Failure Self-Care
October 11, 2010 updated by: Christiana Care Health Services
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19718
- Christiana Care Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1
Telephone management plus a motivational intervention
|
heart failure intervention
|
|
Other: 2
Telephone management with standard patient education
|
heart failure intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barbara Reigel, DNSc, RN, CS, FAAN, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 5, 2007
First Submitted That Met QC Criteria
September 5, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Estimate)
October 13, 2010
Last Update Submitted That Met QC Criteria
October 11, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCC27020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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