NCT02229279

Brief Summary

The objective of this study is to assess the medical and economic relevance of teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

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, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

August 28, 2014

Last Update Submit

January 10, 2017

Conditions

Osteoarthritis, HipOsteoarthritis, Knee

Keywords

Surgical Procedures, Operative

Outcome Measures

Primary Outcomes (1)

  • Functional subscore of simplified WOMAC Scale

    up to 30 days after start of rehabilitation

Secondary Outcomes (5)

  • Joint Paint measured with visual analogue scale

    up to 30 days after start of rehabilitation

  • Patient satisfaction questionnaire

    The last 1 day of the rehabilitation

  • Medical and paramedical staff satisfaction questionnaire

    6 months after enrollment of the first patient

  • Overall costs of treatment

    6 months after enrollment of the first patient

  • Number of hospitalizations and use of emergency units

    Within 30 days after start of rehabilitation

Study Arms (2)

Teleconsulting

ACTIVE COMPARATOR

Teleconsulting

Device: Teleconsulting

No Teleconsulting

NO INTERVENTION

Interventions

TeleconsultingDEVICE
Also known as: Telemedicine
Teleconsulting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Santé Service, Pôle Rééducation- Handicap

Puteaux, 92816, France

Location

Related Publications (5)

  • Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

    PMID: 22617736BACKGROUND

  • Tubach F, Baron G, Falissard B, Logeart I, Dougados M, Bellamy N, Ravaud P. Using patients' and rheumatologists' opinions to specify a short form of the WOMAC function subscale. Ann Rheum Dis. 2005 Jan;64(1):75-9. doi: 10.1136/ard.2003.019539.

    PMID: 15608303BACKGROUND

  • Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.

    PMID: 15208174BACKGROUND

  • Baron G, Tubach F, Ravaud P, Logeart I, Dougados M. Validation of a short form of the Western Ontario and McMaster Universities Osteoarthritis Index function subscale in hip and knee osteoarthritis. Arthritis Rheum. 2007 May 15;57(4):633-8. doi: 10.1002/art.22685.

    PMID: 17471534BACKGROUND

  • Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

    PMID: 26857558DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Dominique Copin, MD

    Fondation Santé Service, Pôle Rééducation - Handicap

    PRINCIPAL INVESTIGATOR

  • Isabelle Durand-Zaleski, MD, PhD

    DRCD URC Eco. Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 1, 2014

Study Start

September 1, 2015

Primary Completion

October 1, 2016

Study Completion

March 1, 2017

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

FR(1)