Evaluation of the Performance of an e-Health System

September 10, 2025 updated by: Air Liquide Santé International

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France, 74000
        • Cabinet Privé de Cardiologie - 2, rue jean jaurès
      • Annecy, France, 74000
        • Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet
      • Pringy, France, 74374
        • Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
      • Pringy, France, 74374
        • Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
      • Saint-Julien-en-Genevois, France, 74160
        • Cabinet privé de pneumologie - 28 avenue de Genève
      • Thônes, France, 74230
        • cabinet privé de médecine générale - 18, rue Louis Haase

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients presenting all the following characteristics are eligible for inclusion:

  1. Adult (>18 yrs), male or female
  2. Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
  3. 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
  4. Able to speak and understand French to a satisfactory standard
  5. Having a phone land line
  6. Capable of understanding and accepting the study constraints
  7. Having signed a written informed consent after a full explanation of the study by the investigator prior to inclusion

Exclusion Criteria:

Patients presenting any one of the following characteristics are not eligible for inclusion:

  1. Pregnant or breast-feeding woman
  2. Institutionalized
  3. Having a life expectancy of less than 3 months
  4. Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
  5. Undergoing dialysis for chronic renal insufficiency
  6. 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
  7. Not covered by French Social Security
  8. Participating or having participated in another interventional trial within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: medical device intervention
Device: medical device intervention
Other Names:
  • Nomhad Mobile - Nomhad Chronic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sensitivity and specificity of the tele-notifications
Time Frame: through study completion, an average of 11 months
through study completion, an average of 11 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the STABILITY SYSTEM INDICATORS
Time Frame: through study completion, an average of 11 months
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
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
Mean number of transmission of measured parameters: real versus theoretical.
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
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
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
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
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
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
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
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
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
through study completion, an average of 11 months
Feasibility of the intervention for patients
Time Frame: through study completion, an average of 11 months
number of screening failure and prematurely withdrawal
through study completion, an average of 11 months
Feasibility of the intervention for technicians
Time Frame: through study completion, an average of 11 months
duration of intervention
through study completion, an average of 11 months
Feasibility of the intervention for nurses
Time Frame: through study completion, an average of 11 months
response time following a notification
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
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
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
technical problems with any medical devices (leading or not to replacement).
through study completion, an average of 11 months
Number of tele-notification per patient
Time Frame: through study completion, an average of 11 months
through study completion, an average of 11 months
Frequency of tele-notifications per patient
Time Frame: through study completion, an average of 11 months
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
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
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.
through study completion, an average of 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Liquide Santé International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Inferential

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephane SH Hominal, doctor, Centre Hospitalier D'Annecy Genevois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALMED-14-MD-051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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