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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02229279
Other study ID # TLM-HAD
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 28, 2014
Last updated January 10, 2017
Start date September 2015
Est. completion date March 2017

Study information

Verified date January 2017
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 430
Est. completion date March 2017
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Teleconsulting


Locations

Country Name City State
France Fondation Santé Service, Pôle Rééducation- Handicap Puteaux

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Agence Regionale de Sante d'Ile de France

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Functional subscore of simplified WOMAC Scale up to 30 days after start of rehabilitation No
Secondary Joint Paint measured with visual analogue scale up to 30 days after start of rehabilitation No
Secondary Patient satisfaction questionnaire The last 1 day of the rehabilitation No
Secondary Medical and paramedical staff satisfaction questionnaire 6 months after enrollment of the first patient No
Secondary Overall costs of treatment 6 months after enrollment of the first patient No
Secondary Number of hospitalizations and use of emergency units Within 30 days after start of rehabilitation No
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