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A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery (RRS)

This study has been completed.
Sponsor:
Collaborators:
Caretech Innovation
Lundbeck Foundation
Information provided by (Responsible Party):
Martin Vesterby, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT00969020
First received: August 28, 2009
Last updated: October 22, 2012
Last verified: October 2012
History of Changes

August 28, 2009
October 22, 2012
September 2009
March 2012   (final data collection date for primary outcome measure)
  • EQ5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • LOS [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    Length of Stay
EQ5D [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00969020 on ClinicalTrials.gov Archive Site
  • SCL-90-r [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    psychological problems and symptoms of psychopathology
  • TUG [ Time Frame: day 90 ] [ Designated as safety issue: No ]
    Time up and go
  • anxiety [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    VAS - anxiety
Not Provided
Not Provided
Not Provided
 
A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery
The Effect of Remote Rehabilitation Support Via a Telemedicine Solution for Patients Undergoing an Optimized Fast-track Orthopedic Surgery Procedure With the Implementation of a Total Hip Arthroplasty.

The RRS project is a Randomized Clinical Trial documenting the effect of Remote Rehabilitation and Support via a telemedicine solution for patients undergoing an optimized fast-track orthopedic surgery procedure with the implementation of a total hip arthroplasty. With the telemedicine solution the investigators will support and try to motivate the patient to be discharged after only one day of hospitalization.

This PhD study evaluates the effect of an information technology solution containing RRS. The way it supports, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.

The parameters evaluated will be: Length of stay, health-related quality-of-life (HRQOL), functional outcome, pain, anxiety, complications and an evaluation of the socio-economic effect.

The aim of the study generates the following hypotheses and focus for publication

  • Length of stay is lower for the intervention group compared to the control group.
  • The average quality of life measured with EQ-5D will either be the same or higher when comparing the intervention group with the control group.
  • Compared to the control group the functional outcome of the intervention group measured with Oxford Hip Score (OHS) and Timed Up and Go (TUG) will be the same or better.
  • Complications measured as luxations, infections, and reoperations are the same or lower in the intervention group compared to the control group.
  • There will be a correlation between patients with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG.
  • There will be a correlation between support persons with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG for the patient they are related to.
  • The socio-economic costs will be lower for the intervention group compared to the control group based on self reported data and data collected from official databases. This study will be conducted as a piggy back to the RCT.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Quality of Life
  • Anxiety
Procedure: remote rehabilitation support
An information technology solution containing RRS. The way it supports,, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.
Other Names:
  • Rehabilitation
  • Fast-track
  • Active Comparator: Telemedicine
    RRS via telemedicine. By developing the concept of Remote Rehabilitation Support (RRS) the investigators will try to bring preoperative education of the patient, dissemination of information and postoperative support to a new level.
    Intervention: Procedure: remote rehabilitation support
  • No Intervention: Standard
    The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients qualified to go trough at joint-care procedure after the guidelines from Regionshospitalet Silkeborg.

Exclusion Criteria:

  • Previous hip surgery with the implantation of a total hip arthroplasty.
  • Patients living more than approximately 60 kilometers from the Regionshospitalet Silkeborg.
  • Patients with no 3G tele-net at their home address.
  • Patients with the need of Danish interpretation.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00969020
2009-RSI-RRS
No
Martin Vesterby, Regionshospitalet Silkeborg
Regionshospitalet Silkeborg
  • Caretech Innovation
  • Lundbeck Foundation
Study Director: Kjeld Soballe, Professor University of Aarhus, Orthopaedic surgical research
Regionshospitalet Silkeborg
October 2012

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