Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures (SSRHAD)

January 10, 2017 updated by: Assistance Publique - Hôpitaux de Paris
The objective of this study is to assess the medical and economic relevance of teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Puteaux, France, 92816
        • Fondation Santé Service, Pôle Rééducation- Handicap

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post hip or knee surgery
  • Fulfilment of criteria for home rehabilitation (no need for hospital treatment post surgery)

Exclusion Criteria:

  • Social isolation
  • Life threatening condition
  • No GSM network
  • No DSL network

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Teleconsulting
Device: Teleconsulting
Other Names:
  • Telemedicine
No Intervention: No Teleconsulting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional subscore of simplified WOMAC Scale
Time Frame: up to 30 days after start of rehabilitation
up to 30 days after start of rehabilitation

Secondary Outcome Measures

Outcome Measure
Time Frame
Joint Paint measured with visual analogue scale
Time Frame: up to 30 days after start of rehabilitation
up to 30 days after start of rehabilitation
Patient satisfaction questionnaire
Time Frame: The last 1 day of the rehabilitation
The last 1 day of the rehabilitation
Medical and paramedical staff satisfaction questionnaire
Time Frame: 6 months after enrollment of the first patient
6 months after enrollment of the first patient
Overall costs of treatment
Time Frame: 6 months after enrollment of the first patient
6 months after enrollment of the first patient
Number of hospitalizations and use of emergency units
Time Frame: Within 30 days after start of rehabilitation
Within 30 days after start of rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence Regionale de Sante d'Ile de France

Investigators

  • Principal Investigator: Dominique Copin, MD, Fondation Santé Service, Pôle Rééducation - Handicap
  • Principal Investigator: Isabelle Durand-Zaleski, MD, PhD, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLM-HAD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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