Evaluation of the Performance of an e-Health System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Performance of an e-Health System Comprising Tele-monitoring / Tele-notification and Tele-coaching in Ambulatory Multi-morbid Adult Patients

Conditions
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Chronic Diseases

Intervention / Treatment
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* Device: medical device intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical device intervention<br> | Device: medical device intervention<br> <br> * Other names: Nomhad Mobile - Nomhad Chronic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the tele-notifications |  | 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 |  | through study completion, an average of 11 months | 
| Specific self-administered questionnaires about Ease of Use/Usefulness/Satisfaction for each category of user |  | 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. | through study completion, an average of 11 months | 
| Acceptability of the system by patients: mean number of participation in virtual classroom session |  | through study completion, an average of 11 months | 
| Acceptability of the system by patients: mean duration of participation in virtual classroom session |  | through study completion, an average of 11 months | 
| Acceptability of the system by patients: mean number of consultations of modules providing medical information |  | through study completion, an average of 11 months | 
| Acceptability of the system by patients: cumulative time spent on consultations of modules providing medical information |  | 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) |  | 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) |  | through study completion, an average of 11 months | 
| Acceptability of the system by patients: comparison of real planned phone contacts versus theoretical |  | through study completion, an average of 11 months | 
| Acceptability of the system by physicians: mean number of connections |  | through study completion, an average of 11 months | 
| Acceptability of the system by physicians: mean duration of connections |  | through study completion, an average of 11 months | 
| Feasibility of the intervention for patients | number of screening failure and prematurely withdrawal | through study completion, an average of 11 months | 
| Feasibility of the intervention for technicians | duration of intervention | through study completion, an average of 11 months | 
| Feasibility of the intervention for nurses | response time following a notification | through study completion, an average of 11 months | 
| Technological performance indices of the system: failures in data transmission |  | through study completion, an average of 11 months | 
| Technological performance indices of the system: inaccessibility |  | 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). | through study completion, an average of 11 months | 
| Number of tele-notification per patient |  | through study completion, an average of 11 months | 
| Frequency of tele-notifications per patient |  | through study completion, an average of 11 months | 
| Patient care plan: number of changes implemented by investigators. |  | 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. | through study completion, an average of 11 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic heart failure, chronic obstructive pulmonary disease, diabetes