Quality of LifeRRSNCT00969020
A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery
A study testing remote rehabilitation support in people with Quality of Life and Anxiety, run by Regionshospitalet Silkeborg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life, Anxiety
- What is being tested?
- remote rehabilitation support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients qualified to go trough at joint-care procedure after the guidelines from Regionshospitalet Silkeborg.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Quality of Life, Anxiety
- Being tested
- remote rehabilitation support
- Keywords
- Length of stay, Timed up and go
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote rehabilitation supportProcedure or surgery
Also called Rehabilitation, Fast-track
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Active comparator | 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. Receives: Procedure: remote rehabilitation support |
| Standard | No intervention | The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ5D
Measured: 12 months
LOS
Length of Stay
Measured: up to 5 days
Secondary outcomes (3)
SCL-90-r
psychological problems and symptoms of psychopathology
Measured: day 0
TUG
Time up and go
Measured: day 90
anxiety
VAS - anxiety
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Silkeborg
- Sponsor type
- University, hospital or other
- Collaborators
- Caretech Innovation, Lundbeck Foundation
- Responsible party
- Principal investigator, Martin Vesterby, Regionshospitalet Silkeborg
- Investigators
- Kjeld Soballe, Professor, Study director, University of Aarhus, Orthopaedic surgical research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969020
- Sponsor's protocol ID
- 2009-RSI-RRS
- Acronym
- RRS
- Status last verified
- Oct 2012
- First submitted
- 28 Aug 2009
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00969020
- Acronym / sponsor ID
- RRS / 2009-RSI-RRS
- Conditions
- Quality of Life, Anxiety
- Keywords
- Length of stay, Timed up and go
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Collaborators
- Caretech Innovation, Lundbeck Foundation
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Active comparator | Procedure: remote rehabilitation supportRRS 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. |
| Standard | No intervention | –The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients qualified to go trough at joint-care procedure after the guidelines from Regionshospitalet Silkeborg.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote rehabilitation supportAlso: Rehabilitation, Fast-trackAn 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. | Procedure or surgery | Telemedicine |
Primary outcome
EQ5D
Time frame: 12 months
LOS
Time frame: up to 5 days
Length of Stay
3 secondary outcomes
SCL-90-r
Time frame: day 0
TUG
Time frame: day 90
anxiety
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjeld Soballe, Professor study director
University of Aarhus, Orthopaedic surgical research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote rehabilitation support in people with Quality of Life and Anxiety, run by Regionshospitalet Silkeborg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ5D (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.