Rehabilitation to Patients Over 65 Years Undergoing THA

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00226070
First received: September 23, 2005
Last updated: December 18, 2006
Last verified: December 2006
  Purpose

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

Condition Intervention Phase
Hip Arthroplasty
Procedure: interview and advising
Behavioral: 3 follow up interviews and personal advising
Procedure: interview SF-36 self rated health
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Cross-Section Study Among Patients Waiting for or Already Undergoing THA Followed by a RCT

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Selfrated health among the population shows significant dysfunction among patients over 75 years, patient living alone and patients depended on help from others

Secondary Outcome Measures:
  • undergoing
  • we know next year

Estimated Enrollment: 160
Study Start Date: September 2004
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:patients over 65 years undergoing total hip replacement

-

Exclusion Criteria:

  • patients dropping out
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226070

Contacts
Contact: Kjeld Soballe 004589497781 ext 45 OVL09KS@dadlnet.dk
Contact: Svend Sabroe 004589424848 ext 45 ss@sosci.au.dk

Locations
Denmark
Kjeld Soballe Recruiting
Aarhus, Aarhus Hospital, Denmark, 8000
Contact: Svend Sabroe, MD, Professor    89424848 ext 45      
Contact: Kjeld Soballe, MD, Professor    89497781 ext 45    ovlo9KS@dadlnet.dk   
Orthopaedic Center Recruiting
University Hospital of Aarhus, Aarhus, Denmark, 8000
Contact: Britta Hordam, MSN, Investigator    004522214383    bhoerdam@mail.dk   
Contact: Kjeld Soballe, MD, DR.Med., Professor    004589497781    OVL09KS@dadlnet.dk   
Kjeld Soballe, Orthopaedic Center Recruiting
Aarhus, Denmark, 8000
Kjeld Soballe, Orthopaedic center, University of Aarhus Recruiting
Aarhus, Denmark, 8000
University of Aarhus, Faculty of Health Sciences, Orthopaedic center Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Svend Sabroe, MD., Professor         
Ortopaedic center, Aarhus University Recruiting
Aarhus, Denmark, Denmark, 8000
Contact: Britta Hordam, MSN    4522214383    bhoerdam@mail.dk   
Contact: Kjeld Soballe, MD,Professor    4589497781 ext 45    OVl09KS@dadlnet.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00226070     History of Changes
Other Study ID Numbers: 1301500110, 1999-2-20
Study First Received: September 23, 2005
Last Updated: December 18, 2006
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
selfrated health,
SF-36,
rehabilitation,
total hip replacement,
patients above 65

ClinicalTrials.gov processed this record on October 22, 2014