NCT00969020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 24, 2012

Status Verified

October 1, 2012

Enrollment Period

2.5 years

First QC Date

August 28, 2009

Last Update Submit

October 22, 2012

Conditions

Keywords

Length of stayTimed up and go

Outcome Measures

Primary Outcomes (2)

  • EQ5D

    12 months

  • LOS

    Length of Stay

    up to 5 days

Secondary Outcomes (3)

  • SCL-90-r

    day 0

  • TUG

    day 90

  • anxiety

    Day 90

Study Arms (2)

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.

Procedure: remote rehabilitation support

Standard

NO INTERVENTION

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

Interventions

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.

Also known as: Rehabilitation, Fast-track
Telemedicine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients qualified to go trough at joint-care procedure after the guidelines from Regionshospitalet Silkeborg.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regionshospitalet SIlkeborg

Silkeborg, Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kjeld Soballe, Professor

    University of Aarhus, Orthopaedic surgical research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2012

Study Completion

August 1, 2012

Last Updated

October 24, 2012

Record last verified: 2012-10

Locations