Rehabilitation to Patients Over 65 Years Undergoing THA
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00226070 |
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Recruitment Status : Unknown
Verified December 2006 by University of Aarhus.
Recruitment status was: Recruiting
First Posted : September 26, 2005
Last Update Posted : December 19, 2006
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Sponsor:
University of Aarhus
Information provided by:
University of Aarhus
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | September 23, 2005 | |||||||||
| First Posted Date ICMJE | September 26, 2005 | |||||||||
| Last Update Posted Date | December 19, 2006 | |||||||||
| Study Start Date ICMJE | September 2004 | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Current Primary Outcome Measures ICMJE |
Selfrated health among the population shows significant dysfunction among patients over 75 years, patient living alone and patients depended on help from others | |||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Rehabilitation to Patients Over 65 Years Undergoing THA | |||||||||
| Official Title ICMJE | Cross-Section Study Among Patients Waiting for or Already Undergoing THA Followed by a RCT | |||||||||
| Brief Summary | Patients over 65 years do not have a self care ability the surgery benefits them. The aim of this study is development of a rehabilitation program based on patients' self-rated health.
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| Detailed Description | Fase 1: 600 patients waiting for or already having received total hip-/knee-replacement participated in a questionnaire study using SF- 36. The aim was to document self-rated health among this population. Fase 2: Results from the cross section study form the base for the RCT, where 160 patients over 65 years undergoing THR, 80 patients are in an intervention group and 80 patients in a control group. A nurse intervention program is tested, and results from the study will form the base for a structured rehabilitation program. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Educational/Counseling/Training |
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| Condition ICMJE | Hip Arthroplasty | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Not Provided | |||||||||
| Publications * | Hørdam B, Sabroe S, Pedersen PU, Mejdahl S, Søballe K. Nursing intervention by telephone interviews of patients aged over 65 years after total hip replacement improves health status: a randomised clinical trial. Scand J Caring Sci. 2010 Mar;24(1):94-100. doi: 10.1111/j.1471-6712.2009.00691.x. Epub 2009 Apr 28. | |||||||||
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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 | Unknown status | |||||||||
| Enrollment ICMJE |
160 | |||||||||
| Original Enrollment ICMJE | Same as current | |||||||||
| Study Completion Date ICMJE | September 2005 | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:patients over 65 years undergoing total hip replacement - Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 65 Years to 95 Years (Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Denmark | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00226070 | |||||||||
| Other Study ID Numbers ICMJE | 1301500110 1999-2-20 |
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| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Not Provided | |||||||||
| Study Sponsor ICMJE | University of Aarhus | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | University of Aarhus | |||||||||
| Verification Date | December 2006 | |||||||||
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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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