Functionally-Impaired ElderlyEVLINENCT02157740
Assessment of Teleconsulting in Nursing Homes
An observational study of Functionally-Impaired Elderly, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
Trial summary
The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents requiring emergent or elective care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Functionally-Impaired Elderly
- What is being tested?
- Residents of nursing homes with telemedicine after implementation of telemedicine
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 9 sitesFrance
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nursing home residents
Who may be able to join
- All residents of selected nursing homes
Who cannot join
- None
Trial locations and contacts
9 sites in 1 country.
Daniel Kharat, MD contact
Mariarita Miano-Joncour contact
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Résidence Le Sequoia
Châtenay-Malabry, 92290
- Recruiting
Résidence Val de France
Domont, 95332
- Recruiting
Résidence la Chanterelle
Le Pré-Saint-Gervais, 93310
- Recruiting
Résidence les Noues
Montereau-Fault-Yonne, 77130
- Recruiting
Résidence La Cerisaie
Poigny-la-Forêt, 78125
- Recruiting
Résidence Saint Rémy
Saint Rémy Les Chevreuse, 78470
- Recruiting
Résidence du Vexin
Saint-Clair-sur-Epte, 95770
- Recruiting
Résidence Klarene
Tournan-en-Brie, 77220
- Recruiting
Résidence Les Pastoureaux
Valenton, 94460
About this study
The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents requiring emergent or elective care.
- Conditions
- Functionally-Impaired Elderly
- Being tested
- Residents of nursing homes with telemedicine after implementation of telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residents of nursing homes with telemedicine after implementation of telemedicineDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group before telemedicine | Residents of nursing homes without telemedicine before implementation of telemedicine in nursing homes with telemedicine | |
| Control group after telemedicine | Residents of nursing homes without telemedicine after implementation of telemedicine in nursing homes with telemedicine | |
| Exposed group, before telemedicine | Residents of nursing homes with telemedicine prior implementation of telemedicine | |
| Exposed group, after telemedicine | Residents of nursing homes with telemedicine after implementation of telemedicine Receives: Device: Residents of nursing homes with telemedicine after implementation of telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient transportation to a emergency unit
Measured: Within 1 year after start of the study
Secondary outcomes (4)
Transportation of the patient for a consultation
Measured: Within 1 year after start of the study
Mean length of hospital stay
Measured: Within 1 year after start of the study
Number of hospitalizations
Measured: Within 1 year after start of the study
Overall costs
Measured: Within 1 year after start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functionally-Impaired ElderlyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 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
- Isabelle Durand-Zaleski, MD, PhD, Principal investigator, DRCD URC Eco. Assistance Publique, Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157740
- Sponsor's protocol ID
- TLM-EVLINE
- Acronym
- EVLINE
- Status last verified
- Oct 2015
- First submitted
- 27 May 2014
- Last updated
- 14 Oct 2015
- 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 22617736Charrier 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 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Teleconsulting in Nursing Homes
- ClinicalTrials.gov ID
- NCT02157740
- Acronym / sponsor ID
- EVLINE / TLM-EVLINE
- Conditions
- Functionally-Impaired Elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Jun 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 purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents requiring emergent or elective care.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group before telemedicine | – | –Residents of nursing homes without telemedicine before implementation of telemedicine in nursing homes with telemedicine |
| Control group after telemedicine | – | –Residents of nursing homes without telemedicine after implementation of telemedicine in nursing homes with telemedicine |
| Exposed group, before telemedicine | – | –Residents of nursing homes with telemedicine prior implementation of telemedicine |
| Exposed group, after telemedicine | – | Device: Residents of nursing homes with telemedicine after implementation of telemedicineResidents of nursing homes with telemedicine after implementation of telemedicine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nursing home residents
Key inclusion criteria (1 listed)
- All residents of selected nursing homes
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Residents of nursing homes with telemedicine after implementation of telemedicine | Device | Exposed group, after telemedicine |
Primary outcome
Patient transportation to a emergency unit
Time frame: Within 1 year after start of the study
4 secondary outcomes
Transportation of the patient for a consultation
Time frame: Within 1 year after start of the study
Mean length of hospital stay
Time frame: Within 1 year after start of the study
Number of hospitalizations
Time frame: Within 1 year after start of the study
Overall costs
Time frame: Within 1 year after start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- 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.
- 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.
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.
Daniel Kharat, MD contact
Mariarita Miano-Joncour contact
Isabelle Durand-Zaleski, MD, PhD principal investigator
DRCD URC Eco. Assistance Publique, Hôpitaux de Paris
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functionally-Impaired Elderly, run by Assistance Publique - Hôpitaux de Paris at 9 sites 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 1 inclusion and 1 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Contact Daniel Kharat, MD (d.kharat@orpea.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient transportation to a emergency unit (time frame: Within 1 year after start of the study). 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 NCT02157740, which also lists 2 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 14 Oct 2015.