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Tracking Information | |||||
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First Received Date ICMJE | March 24, 2008 | ||||
Last Updated Date | January 4, 2010 | ||||
Start Date ICMJE | March 2008 | ||||
Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
dietary sodium intake [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00645489 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Family Intervention for Improving Self-Care of Patients With Heart Failure | ||||
Official Title ICMJE | A Family Intervention for Improving Self-Care of Patients With Heart Failure | ||||
Brief Summary | This is a pilot study of a family-based educational program for patients with heart failure, and their family members. |
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Detailed Description |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 0 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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Condition ICMJE | Heart Failure, Congestive | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 40 | ||||
Completion Date | December 2009 | ||||
Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00645489 | ||||
Other Study ID Numbers ICMJE | MIRECC002, 01008, 0008 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Sayers, Steven - Principal Investigator, Department of Veterans Affairs | ||||
Study Sponsor ICMJE | Department of Veterans Affairs | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Department of Veterans Affairs | ||||
Verification Date | December 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |