Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
This study is ongoing, but not recruiting participants.
Sponsor:
Carol Smith, RN, PhD, FAAN
Collaborator:
Information provided by (Responsible Party):
Carol Smith, RN, PhD, FAAN, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00439842
First received: February 22, 2007
Last updated: January 28, 2013
Last verified: January 2013
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| First Received Date ICMJE | February 22, 2007 | ||||
| Last Updated Date | January 28, 2013 | ||||
| Start Date ICMJE | March 2007 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
rehospitalization or death [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00439842 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF) | ||||
| Official Title ICMJE | HF Group Clinic Appointments: Rehospitalization Prevention | ||||
| Brief Summary | The purpose of this study is to help people with heart failure (HF) to manage their HF and to prevent rehospitalizations. Another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their HF. It is proposed that the group clinic intervention (HFcareGroup)will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms. |
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| Detailed Description | Aim 1 Hypothesis:
Aim 2 Hypothesis:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE | Heart Failure, Congestive | ||||
| Intervention ICMJE | Behavioral: Heart Failure Group Clinic Appointments
Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)
Other Name: HFcareGroup |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* 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 | Active, not recruiting | ||||
| Enrollment ICMJE | 198 | ||||
| Estimated Completion Date | May 2014 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 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 | NCT00439842 | ||||
| Other Study ID Numbers ICMJE | 1RO1 HL085397-05, R01HL085397 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Carol Smith, RN, PhD, FAAN, University of Kansas Medical Center Research Institute | ||||
| Study Sponsor ICMJE | Carol Smith, RN, PhD, FAAN | ||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kansas | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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