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Rehabilitation to Patients Over 65 Years Undergoing THA

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ClinicalTrials.gov Identifier: NCT00226070
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
Sponsor:
Information provided by:
University of Aarhus

Tracking Information
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
 (submitted: September 23, 2005)
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
 (submitted: September 23, 2005)
  • undergoing
  • we know next year
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.

  1. A cross section study including 600 patients
  2. RCT including 160 patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE Hip Arthroplasty
Intervention  ICMJE
  • Procedure: interview and advising
  • Behavioral: 3 follow up interviews and personal advising
  • Procedure: interview SF-36 self rated health
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 23, 2005)
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:

  • patients dropping out
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
Principal Investigator: Kjeld Soballe, MD, Professor Ortopaedic Center, Aarhus University Hospital, Aarhus Denmark
Principal Investigator: Kjeld Soballe Department of Orthopaedics, Aarhus University Hospital, Tage Hansensgade 10, DK-8000 Aarhus C
Principal Investigator: Kjeld Soballe, MD,DR.Med.,Professor Aarhus University Hospitak,Ortopaedic center, Aarhus Denmark
PRS Account University of Aarhus
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP