Osteoarthritis, HipSSRHADNCT02229279
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures
A study testing Teleconsulting in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- Teleconsulting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post hip or knee surgery
- Fulfilment of criteria for home rehabilitation (no need for hospital treatment post surgery)
Who cannot join
- Social isolation
- Life threatening condition
- No GSM network
- No DSL network
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Santé Service, Pôle Rééducation- Handicap
Puteaux, 92816
About this study
The objective of this study is to assess the medical and economic relevance of teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee
- Being tested
- Teleconsulting
- Keywords
- Surgical Procedures, Operative
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconsultingDevice
Also called Telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Teleconsulting | Active comparator | Teleconsulting Receives: Device: Teleconsulting |
| No Teleconsulting | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional subscore of simplified WOMAC Scale
Measured: up to 30 days after start of rehabilitation
Secondary outcomes (5)
Joint Paint measured with visual analogue scale
Measured: up to 30 days after start of rehabilitation
Patient satisfaction questionnaire
Measured: The last 1 day of the rehabilitation
Medical and paramedical staff satisfaction questionnaire
Measured: 6 months after enrollment of the first patient
Overall costs of treatment
Measured: 6 months after enrollment of the first patient
Number of hospitalizations and use of emergency units
Measured: Within 30 days after start of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Dominique Copin, MD, Principal investigator, Fondation Santé Service, Pôle Rééducation - HandicapIsabelle Durand-Zaleski, MD, PhD, Principal investigator, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229279
- Sponsor's protocol ID
- TLM-HAD
- Acronym
- SSRHAD
- Status last verified
- Jan 2017
- First submitted
- 28 Aug 2014
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22617736Tubach 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.
PubMed 15608303Tubach 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.
PubMed 15208174Baron 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.
PubMed 17471534Charrier 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.
PubMed 26857558
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures
- ClinicalTrials.gov ID
- NCT02229279
- Acronym / sponsor ID
- SSRHAD / TLM-HAD
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee
- Keywords
- Surgical Procedures, Operative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the medical and economic relevance of teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleconsulting | Active comparator | Device: TeleconsultingTeleconsulting |
| No Teleconsulting | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post hip or knee surgery
- Fulfilment of criteria for home rehabilitation (no need for hospital treatment post surgery)
Key exclusion criteria (4 listed)
- Social isolation
- Life threatening condition
- No GSM network
- No DSL network
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleconsultingAlso: Telemedicine | Device | Teleconsulting |
Primary outcome
Functional subscore of simplified WOMAC Scale
Time frame: up to 30 days after start of rehabilitation
5 secondary outcomes
Joint Paint measured with visual analogue scale
Time frame: up to 30 days after start of rehabilitation
Patient satisfaction questionnaire
Time frame: The last 1 day of the rehabilitation
Medical and paramedical staff satisfaction questionnaire
Time frame: 6 months after enrollment of the first patient
Overall costs of treatment
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Background: PubMed 22617736Kidholm 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.
- Background: PubMed 15608303Tubach 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.
- Background: PubMed 15208174Tubach 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.
- Background: PubMed 17471534Baron 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.
- Derived from this study: PubMed 26857558Charrier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Copin, MD principal investigator
Fondation Santé Service, Pôle Rééducation - Handicap
Isabelle Durand-Zaleski, MD, PhD principal investigator
DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsulting in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional subscore of simplified WOMAC Scale (time frame: up to 30 days after start of rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229279, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.