Clinical trial NCT00969020: A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Anxiety
Keywords: Length of stay
Timed up and go
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
Collaborators: name: Caretech Innovation
name: Lundbeck Foundation
First posted: 2009-08-31
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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.

Primary outcomes:
measure: EQ5D
timeFrame: 12 months
measure: LOS
timeFrame: up to 5 days
Secondary outcomes:
measure: SCL-90-r
timeFrame: day 0
measure: TUG
timeFrame: day 90
measure: anxiety
timeFrame: Day 90
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Regionshospitalet SIlkeborg
Study officials:
affiliation: University of Aarhus, Orthopaedic surgical research
name: Kjeld Soballe, Professor
role: STUDY_DIRECTOR
References: