Chronic DiseasesNCT02803489
Evaluation of the Performance of an e-Health System
A study testing medical device intervention in people with Chronic Diseases, run by Air Liquide Santé International at 6 sites in France.
Trial summary
Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- medical device intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 6 sitesFrance
- Study dates
- 8 Apr 2016to 9 May 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
- Patients presenting all the following characteristics are eligible for inclusion:
- Adult (>18 yrs), male or female
- Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
- Having been hospitalized in the CHANGE or in any other medical care center (hospital or private clinic) for acute decompensation of CHF or exacerbation of COPD at least once during the 12 months prior to inclusion
- Able to speak and understand French to a satisfactory standard
- Having a phone land line
- Capable of understanding and accepting the study constraints
- Having signed a written informed consent after a full explanation of the study by the investigator prior to inclusion
Who cannot join
- Patients presenting any one of the following characteristics are not eligible for inclusion:
- Pregnant or breast-feeding woman
- Institutionalized
- Having a life expectancy of less than 3 months
- Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
- Undergoing dialysis for chronic renal insufficiency
Show all 9Show fewer
- Presenting a condition likely to hamper accomplishment of the study procedures, such as chronic alcoholism, drug or solvent addiction, uncontrolled psychiatric disease or severe cognitive deficiency
- Not covered by French Social Security
- Participating or having participated in another interventional trial within the past 30 days
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Cabinet Privé de Cardiologie - 2, rue jean jaurès
Annecy, 74000
Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet
Annecy, 74000
Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
Pringy, 74374
Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
Pringy, 74374
Cabinet privé de pneumologie - 28 avenue de Genève
Saint-Julien-en-Genevois, 74160
cabinet privé de médecine générale - 18, rue Louis Haase
Thônes, 74230
About this study
Official title: Evaluation of the Performance of an e-Health System Comprising Tele-monitoring / Tele-notification and Tele-coaching in Ambulatory Multi-morbid Adult Patients
Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.
Read the detailed description
The eHealth system developed in the present study is dedicated to multimorbid patients' follow-up. The medical device consists in Telemonitoring, Telenotification and Telecoaching. It aims to both increase patient autonomy, with regard to management of his/her pathologies, and facilitate coordination between health professionals.
By providing patients with tools enabling early detection of clinical worsening combined with an appropriate management, the medium and long-term objectives are to reduce hospitalizations and improve health status and quality of life of these patients at home.
In the first instance, the only objective of the present study is to evaluate the performance and feasibility of implementation of the device. This evaluation is based on a comparison between the telenotifications generated by the software and those calculated from the raw data captured by the software.
- Conditions
- Chronic Diseases
- Being tested
- medical device intervention
- Keywords
- chronic heart failure, chronic obstructive pulmonary disease, diabetes
- Medical subject headings
- Chronic Disease, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical device interventionDevice
Also called Nomhad Mobile - Nomhad Chronic
| Study group | Role | What they receive |
|---|---|---|
| medical device intervention | Experimental | Not described Receives: Device: medical device intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the tele-notifications
Measured: through study completion, an average of 11 months
Secondary outcomes (22)
Sensitivity and specificity of the STABILITY SYSTEM INDICATORS
Measured: through study completion, an average of 11 months
Specific self-administered questionnaires about Ease of Use/Usefulness/Satisfaction for each category of user
Measured: through study completion, an average of 11 months
Acceptability of the system by patients regarding transmission of measured parameters
Mean number of transmission of measured parameters: real versus theoretical.
Measured: through study completion, an average of 11 months
Acceptability of the system by patients: mean number of participation in virtual classroom session
Measured: through study completion, an average of 11 months
Acceptability of the system by patients: mean duration of participation in virtual classroom session
Measured: through study completion, an average of 11 months
Acceptability of the system by patients: mean number of consultations of modules providing medical information
Measured: through study completion, an average of 11 months
Acceptability of the system by patients: cumulative time spent on consultations of modules providing medical information
Measured: through study completion, an average of 11 months
Acceptability of the system by patients: mean duration of phone contacts by type (planned, for notification management, incoming)
Measured: through study completion, an average of 11 months
Acceptability of the system by patients: mean number of phone contacts by type (planned, for notification management, incoming)
Measured: through study completion, an average of 11 months
Acceptability of the system by patients: comparison of real planned phone contacts versus theoretical
Measured: through study completion, an average of 11 months
Acceptability of the system by physicians: mean number of connections
Measured: through study completion, an average of 11 months
Acceptability of the system by physicians: mean duration of connections
Measured: through study completion, an average of 11 months
Feasibility of the intervention for patients
number of screening failure and prematurely withdrawal
Measured: through study completion, an average of 11 months
Feasibility of the intervention for technicians
duration of intervention
Measured: through study completion, an average of 11 months
Feasibility of the intervention for nurses
response time following a notification
Measured: through study completion, an average of 11 months
Technological performance indices of the system: failures in data transmission
Measured: through study completion, an average of 11 months
Technological performance indices of the system: inaccessibility
Measured: through study completion, an average of 11 months
Technological performance indices of the system: devices deficiencies
technical problems with any medical devices (leading or not to replacement).
Measured: through study completion, an average of 11 months
Number of tele-notification per patient
Measured: through study completion, an average of 11 months
Frequency of tele-notifications per patient
Measured: through study completion, an average of 11 months
Patient care plan: number of changes implemented by investigators.
Measured: through study completion, an average of 11 months
Clinical events including medical consultations, hospitalizations and adverse events
Overall description of medical consultations, hospitalizations and adverse events. For adverse events, in addition, evaluation of seriousness and causal relationship with the medical device of the study.
Measured: through study completion, an average of 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start8 Apr 2016
- Primary completion23 Mar 2017
- Study completion9 May 2017
Why it stopped: inclusion rate too low \& investigators enable to recruit new patients rapidly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inferential
- Responsible party
- Sponsor
- Investigators
- Stephane SH Hominal, doctor, Principal investigator, Centre hospitalier d'Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803489
- Sponsor's protocol ID
- ALMED-14-MD-051
- Status last verified
- Sep 2025
- First submitted
- 23 May 2016
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. doi: 10.1164/rccm.200310-1443OC. Epub 2004 Feb 27.
PubMed 14990395Conway G. Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006 Mar;5(1):25-8. doi: 10.1097/01.hpc.0000202240.99184.81.
PubMed 18340214Elbert NJ, van Os-Medendorp H, van Renselaar W, Ekeland AG, Hakkaart-van Roijen L, Raat H, Nijsten TE, Pasmans SG. Effectiveness and cost-effectiveness of ehealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. J Med Internet Res. 2014 Apr 16;16(4):e110. doi: 10.2196/jmir.2790.
PubMed 24739471Marcolino MS, Maia JX, Alkmim MB, Boersma E, Ribeiro AL. Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS One. 2013 Nov 8;8(11):e79246. doi: 10.1371/journal.pone.0079246. eCollection 2013.
PubMed 24250826Lundell S, Holmner A, Rehn B, Nyberg A, Wadell K. Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Respir Med. 2015 Jan;109(1):11-26. doi: 10.1016/j.rmed.2014.10.008. Epub 2014 Oct 27.
PubMed 25464906Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014 Mar;68(3):369-78. doi: 10.1111/ijcp.12345. Epub 2014 Jan 28.
PubMed 24472009Goldstein RS, O'Hoski S. Telemedicine in COPD: time to pause. Chest. 2014 May;145(5):945-949. doi: 10.1378/chest.13-1656.
PubMed 24798834Conway A, Inglis SC, Chang AM, Horton-Breshears M, Cleland JG, Clark RA. Not all systematic reviews are systematic: a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure. J Telemed Telecare. 2013 Sep;19(6):326-37. doi: 10.1177/1357633X13503427. Epub 2013 Sep 25.
PubMed 24163297Nakamura N, Koga T, Iseki H. A meta-analysis of remote patient monitoring for chronic heart failure patients. J Telemed Telecare. 2014 Jan;20(1):11-7. doi: 10.1177/1357633X13517352. Epub 2013 Dec 18.
PubMed 24352899Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43.
PubMed 24606887Kitsiou S, Pare G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. J Med Internet Res. 2015 Mar 12;17(3):e63. doi: 10.2196/jmir.4174.
PubMed 25768664Kotb A, Cameron C, Hsieh S, Wells G. Comparative effectiveness of different forms of telemedicine for individuals with heart failure (HF): a systematic review and network meta-analysis. PLoS One. 2015 Feb 25;10(2):e0118681. doi: 10.1371/journal.pone.0118681. eCollection 2015.
PubMed 25714962Pandor A, Gomersall T, Stevens JW, Wang J, Al-Mohammad A, Bakhai A, Cleland JG, Cowie MR, Wong R. Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis. Heart. 2013 Dec;99(23):1717-26. doi: 10.1136/heartjnl-2013-303811. Epub 2013 May 16.
PubMed 23680885Feltner C, Jones CD, Cene CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJ, Arvanitis M, Lohr KN, Middleton JC, Jonas DE. Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med. 2014 Jun 3;160(11):774-84. doi: 10.7326/M14-0083.
PubMed 24862840Kitsiou S, Pare G, Jaana M. Systematic reviews and meta-analyses of home telemonitoring interventions for patients with chronic diseases: a critical assessment of their methodological quality. J Med Internet Res. 2013 Jul 23;15(7):e150. doi: 10.2196/jmir.2770.
PubMed 23880072
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of an e-Health System Comprising Tele-monitoring / Tele-notification and Tele-coaching in Ambulatory Multi-morbid Adult Patients
- ClinicalTrials.gov ID
- NCT02803489
- Acronym / sponsor ID
- ALMED-14-MD-051
- Conditions
- Chronic Diseases
- Keywords
- chronic heart failure, chronic obstructive pulmonary disease, diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion rate too low \& investigators enable to recruit new patients rapidly
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Inferential
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 17 Jun 2016 (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.
Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.
Detailed description
The eHealth system developed in the present study is dedicated to multimorbid patients' follow-up. The medical device consists in Telemonitoring, Telenotification and Telecoaching. It aims to both increase patient autonomy, with regard to management of his/her pathologies, and facilitate coordination between health professionals.
By providing patients with tools enabling early detection of clinical worsening combined with an appropriate management, the medium and long-term objectives are to reduce hospitalizations and improve health status and quality of life of these patients at home.
In the first instance, the only objective of the present study is to evaluate the performance and feasibility of implementation of the device. This evaluation is based on a comparison between the telenotifications generated by the software and those calculated from the raw data captured by the software.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical device intervention | Experimental | Device: medical device intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (>18 yrs), male or female
- Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
- Having been hospitalized in the CHANGE or in any other medical care center (hospital or private clinic) for acute decompensation of CHF or exacerbation of COPD at least once during the 12 months prior to inclusion
- Able to speak and understand French to a satisfactory standard
- Having a phone land line
Key exclusion criteria (9 listed)
- Patients presenting any one of the following characteristics are not eligible for inclusion:
- Pregnant or breast-feeding woman
- Institutionalized
- Having a life expectancy of less than 3 months
- Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
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 |
|---|---|---|
| medical device interventionAlso: Nomhad Mobile - Nomhad Chronic | Device | medical device intervention |
Primary outcome
Sensitivity and specificity of the tele-notifications
Time frame: through study completion, an average of 11 months
22 secondary outcomes
Sensitivity and specificity of the STABILITY SYSTEM INDICATORS
Time frame: through study completion, an average of 11 months
Specific self-administered questionnaires about Ease of Use/Usefulness/Satisfaction for each category of user
Time frame: through study completion, an average of 11 months
Acceptability of the system by patients regarding transmission of measured parameters
Time frame: through study completion, an average of 11 months
Acceptability of the system by patients: mean number of participation in virtual classroom session
Time frame: through study completion, an average of 11 months
Acceptability of the system by patients: mean duration of participation in virtual classroom session
Time frame: through study completion, an average of 11 months
Acceptability of the system by patients: mean number of consultations of modules providing medical information
Time frame: through study completion, an average of 11 months
Acceptability of the system by patients: cumulative time spent on consultations of modules providing medical information
Time frame: through study completion, an average of 11 months
Acceptability of the system by patients: mean duration of phone contacts by type (planned, for notification management, incoming)
Time frame: through study completion, an average of 11 months
Acceptability of the system by patients: mean number of phone contacts by type (planned, for notification management, incoming)
Time frame: through study completion, an average of 11 months
Acceptability of the system by patients: comparison of real planned phone contacts versus theoretical
Time frame: through study completion, an average of 11 months
Acceptability of the system by physicians: mean number of connections
Time frame: through study completion, an average of 11 months
Acceptability of the system by physicians: mean duration of connections
Time frame: through study completion, an average of 11 months
Feasibility of the intervention for patients
Time frame: through study completion, an average of 11 months
Feasibility of the intervention for technicians
Time frame: through study completion, an average of 11 months
Feasibility of the intervention for nurses
Time frame: through study completion, an average of 11 months
Technological performance indices of the system: failures in data transmission
Time frame: through study completion, an average of 11 months
Technological performance indices of the system: inaccessibility
Time frame: through study completion, an average of 11 months
Technological performance indices of the system: devices deficiencies
Time frame: through study completion, an average of 11 months
Number of tele-notification per patient
Time frame: through study completion, an average of 11 months
Frequency of tele-notifications per patient
Time frame: through study completion, an average of 11 months
Patient care plan: number of changes implemented by investigators.
Time frame: through study completion, an average of 11 months
Clinical events including medical consultations, hospitalizations and adverse events
Time frame: through study completion, an average of 11 months
Results and safety
The study was stopped early (reason given: inclusion rate too low \& investigators enable to recruit new patients rapidly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 14990395Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. doi: 10.1164/rccm.200310-1443OC. Epub 2004 Feb 27.
- Background: PubMed 18340214Conway G. Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006 Mar;5(1):25-8. doi: 10.1097/01.hpc.0000202240.99184.81.
- Background: PubMed 24739471Elbert NJ, van Os-Medendorp H, van Renselaar W, Ekeland AG, Hakkaart-van Roijen L, Raat H, Nijsten TE, Pasmans SG. Effectiveness and cost-effectiveness of ehealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. J Med Internet Res. 2014 Apr 16;16(4):e110. doi: 10.2196/jmir.2790.
- Background: PubMed 24250826Marcolino MS, Maia JX, Alkmim MB, Boersma E, Ribeiro AL. Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS One. 2013 Nov 8;8(11):e79246. doi: 10.1371/journal.pone.0079246. eCollection 2013.
- Background: PubMed 25464906Lundell S, Holmner A, Rehn B, Nyberg A, Wadell K. Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Respir Med. 2015 Jan;109(1):11-26. doi: 10.1016/j.rmed.2014.10.008. Epub 2014 Oct 27.
- Background: PubMed 24472009Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014 Mar;68(3):369-78. doi: 10.1111/ijcp.12345. Epub 2014 Jan 28.
- Background: PubMed 24798834Goldstein RS, O'Hoski S. Telemedicine in COPD: time to pause. Chest. 2014 May;145(5):945-949. doi: 10.1378/chest.13-1656.
- Background: PubMed 24163297Conway A, Inglis SC, Chang AM, Horton-Breshears M, Cleland JG, Clark RA. Not all systematic reviews are systematic: a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure. J Telemed Telecare. 2013 Sep;19(6):326-37. doi: 10.1177/1357633X13503427. Epub 2013 Sep 25.
- Background: PubMed 24352899Nakamura N, Koga T, Iseki H. A meta-analysis of remote patient monitoring for chronic heart failure patients. J Telemed Telecare. 2014 Jan;20(1):11-7. doi: 10.1177/1357633X13517352. Epub 2013 Dec 18.
- Background: PubMed 24606887Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43.
- Background: PubMed 25768664Kitsiou S, Pare G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. J Med Internet Res. 2015 Mar 12;17(3):e63. doi: 10.2196/jmir.4174.
- Background: PubMed 25714962Kotb A, Cameron C, Hsieh S, Wells G. Comparative effectiveness of different forms of telemedicine for individuals with heart failure (HF): a systematic review and network meta-analysis. PLoS One. 2015 Feb 25;10(2):e0118681. doi: 10.1371/journal.pone.0118681. eCollection 2015.
- Individual participant dataSharing planned: No
Related trials for Chronic Diseases
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Stephane SH Hominal, doctor principal investigator
Centre hospitalier d'Annecy Genevois
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical device intervention in people with Chronic Diseases, run by Air Liquide Santé International at 6 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study was stopped early (reason given: inclusion rate too low \& investigators enable to recruit new patients rapidly). 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?
Sensitivity and specificity of the tele-notifications (time frame: through study completion, an average of 11 months). 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 NCT02803489, which also lists 28 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 Sep 2025.