A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery (RRS)
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|ClinicalTrials.gov Identifier: NCT00969020|
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : October 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life Anxiety||Procedure: remote rehabilitation support||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (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.|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||August 2012|
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.
No Intervention: Standard
The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery
- EQ5D [ Time Frame: 12 months ]
- LOS [ Time Frame: up to 5 days ]Length of Stay
- SCL-90-r [ Time Frame: day 0 ]psychological problems and symptoms of psychopathology
- TUG [ Time Frame: day 90 ]Time up and go
- anxiety [ Time Frame: Day 90 ]VAS - anxiety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969020
|Silkeborg, Denmark, 8600|
|Study Director:||Kjeld Soballe, Professor||University of Aarhus, Orthopaedic surgical research|