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Rehabilitation to Patients Over 65 Years Undergoing THA
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by University of Aarhus.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Aarhus
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00226070
First received: September 23, 2005
Last updated: December 18, 2006
Last verified: December 2006
| Tracking Information | ||||||||||
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| First Received Date ICMJE | September 23, 2005 | |||||||||
| Last Updated Date | December 18, 2006 | |||||||||
| 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 | Complete list of historical versions of study NCT00226070 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | 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 | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Educational/Counseling/Training |
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| Condition ICMJE | Hip Arthroplasty | |||||||||
| Intervention ICMJE |
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| Study Arms | 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 | |||||||||
| Estimated Completion Date | 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 |
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| Ages | 65 Years to 95 Years (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | 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 | 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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