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
  Purpose

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.


Condition Intervention
Quality of Life
Anxiety
Procedure: remote rehabilitation support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Regionshospitalet Silkeborg:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 72
Study Start Date: September 2009
Study Completion Date: August 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Standard
The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery

Detailed Description:

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00969020

Locations
Denmark
Regionshospitalet SIlkeborg
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Regionshospitalet Silkeborg
Caretech Innovation
Lundbeck Foundation
Investigators
Study Director: Kjeld Soballe, Professor University of Aarhus, Orthopaedic surgical research
  More Information

No publications provided

Responsible Party: Martin Vesterby, MD, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier: NCT00969020     History of Changes
Other Study ID Numbers: 2009-RSI-RRS
Study First Received: August 28, 2009
Last Updated: October 22, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Ministry of the Interior and Health
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Regionshospitalet Silkeborg:
Length of stay
Timed up and go

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014