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

NCT ID: NCT00969020

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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

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Quality of Life Anxiety

Keywords

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Length of stay Timed up and go

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

remote rehabilitation support

Intervention Type PROCEDURE

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.

Standard

The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Rehabilitation Fast-track

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Caretech Innovation

UNKNOWN

Sponsor Role collaborator

Lundbeck Foundation

OTHER

Sponsor Role collaborator

Regionshospitalet Silkeborg

OTHER

Sponsor Role lead

Responsible Party

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Martin Vesterby

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kjeld Soballe, Professor

Role: STUDY_DIRECTOR

University of Aarhus, Orthopaedic surgical research

Locations

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Regionshospitalet SIlkeborg

Silkeborg, Silkeborg, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2009-RSI-RRS

Identifier Type: -

Identifier Source: org_study_id