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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

23

Phase

  • 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

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
Intervention / Treatment
Experimental: medical device intervention
Device: medical device intervention
Other Names:
  • Nomhad Mobile - Nomhad Chronic

What is the study measuring?

Primary Outcome Measures

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

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

Air Liquide Santé International

Collaborators

Inferential

Investigators

  • 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)

April 8, 2016

Primary Completion (Actual)

March 23, 2017

Study Completion (Actual)

May 9, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimated)

June 17, 2016

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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