Clinical trial NCT02803489: Evaluation of the Performance of an e-Health System
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Diseases
Keywords: chronic heart failure
chronic obstructive pulmonary disease
diabetes
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: Inferential
First posted: 2016-06-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of the tele-notifications
timeFrame: through study completion, an average of 11 months
Secondary outcomes:
measure: Sensitivity and specificity of the STABILITY SYSTEM INDICATORS
timeFrame: through study completion, an average of 11 months
measure: Specific self-administered questionnaires about Ease of Use/Usefulness/Satisfaction for each category of user
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by patients regarding transmission of measured parameters
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by patients: mean number of participation in virtual classroom session
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by patients: mean duration of participation in virtual classroom session
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by patients: mean number of consultations of modules providing medical information
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by patients: cumulative time spent on consultations of modules providing medical information
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by patients: mean duration of phone contacts by type (planned, for notification management, incoming)
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by patients: mean number of phone contacts by type (planned, for notification management, incoming)
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by patients: comparison of real planned phone contacts versus theoretical
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by physicians: mean number of connections
timeFrame: through study completion, an average of 11 months
measure: Acceptability of the system by physicians: mean duration of connections
timeFrame: through study completion, an average of 11 months
measure: Feasibility of the intervention for patients
timeFrame: through study completion, an average of 11 months
measure: Feasibility of the intervention for technicians
timeFrame: through study completion, an average of 11 months
measure: Feasibility of the intervention for nurses
timeFrame: through study completion, an average of 11 months
measure: Technological performance indices of the system: failures in data transmission
timeFrame: through study completion, an average of 11 months
measure: Technological performance indices of the system: inaccessibility
timeFrame: through study completion, an average of 11 months
measure: Technological performance indices of the system: devices deficiencies
timeFrame: through study completion, an average of 11 months
measure: Number of tele-notification per patient
timeFrame: through study completion, an average of 11 months
measure: Frequency of tele-notifications per patient
timeFrame: through study completion, an average of 11 months
measure: Patient care plan: number of changes implemented by investigators.
timeFrame: through study completion, an average of 11 months
measure: Clinical events including medical consultations, hospitalizations and adverse events
timeFrame: through study completion, an average of 11 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Cabinet Privé de Cardiologie - 2, rue jean jaurès
city: Annecy
country: France
facility: Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet
city: PRINGY Cedex
country: France
facility: Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
city: Pringy cedex
country: France
facility: Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
city: Saint Julien en Genevois
country: France
facility: Cabinet privé de pneumologie - 28 avenue de Genève
city: Thones
country: France
facility: cabinet privé de médecine générale - 18, rue Louis Haase
Study officials:
affiliation: Centre hospitalier d'Annecy Genevois
name: Stephane SH Hominal, doctor
role: PRINCIPAL_INVESTIGATOR
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