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

Primary Purpose

Osteoarthritis, Hip, Osteoarthritis, Knee

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Teleconsulting

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Surgical Procedures, Operative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fondation Santé Service, Pôle Rééducation- Handicap

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Teleconsulting

No Teleconsulting

Arm Description

Teleconsulting

Outcomes

Primary Outcome Measures

Functional subscore of simplified WOMAC Scale

Secondary Outcome Measures

Joint Paint measured with visual analogue scale

Patient satisfaction questionnaire

Medical and paramedical staff satisfaction questionnaire

Overall costs of treatment

Number of hospitalizations and use of emergency units

Full Information

NCT ID

NCT02229279

First Posted

August 28, 2014

Last Updated

January 10, 2017

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence Regionale de Sante d'Ile de France

1. Study Identification

Unique Protocol Identification Number

NCT02229279

Brief Title

Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures

Acronym

SSRHAD

Official Title

Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence Regionale de Sante d'Ile de France

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Hip, Osteoarthritis, Knee

Keywords

Surgical Procedures, Operative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Teleconsulting

Arm Type

Active Comparator

Arm Description

Teleconsulting

Arm Title

No Teleconsulting

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

Teleconsulting

Other Intervention Name(s)

Telemedicine

Primary Outcome Measure Information:

Title

Functional subscore of simplified WOMAC Scale

Time Frame

up to 30 days after start of rehabilitation

Secondary Outcome Measure Information:

Title

Joint Paint measured with visual analogue scale

Time Frame

up to 30 days after start of rehabilitation

Title

Patient satisfaction questionnaire

Time Frame

The last 1 day of the rehabilitation

Title

Medical and paramedical staff satisfaction questionnaire

Time Frame

6 months after enrollment of the first patient

Title

Overall costs of treatment

Time Frame

6 months after enrollment of the first patient

Title

Number of hospitalizations and use of emergency units

Time Frame

Within 30 days after start of rehabilitation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominique Copin, MD

Organizational Affiliation

Fondation Santé Service, Pôle Rééducation - Handicap

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Isabelle Durand-Zaleski, MD, PhD

Organizational Affiliation

DRCD URC Eco. Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondation Santé Service, Pôle Rééducation- Handicap

City

Puteaux

ZIP/Postal Code

92816

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

22617736

Citation

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.

Results Reference

background

PubMed Identifier

15608303

Citation

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.

Results Reference

background

PubMed Identifier

15208174

Citation

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.

Results Reference

background

PubMed Identifier

17471534

Citation

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.

Results Reference

background

PubMed Identifier

26857558

Citation

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.

Results Reference

derived

Links:

URL

http://www.renewinghealth.eu/assessment-method

Description

Related Info

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Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures

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