Back to resultsEvaluation of the Performance of an e-Health System
Primary Purpose
Chronic Diseases
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
medical device intervention
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Diseases focused on measuring chronic heart failure, chronic obstructive pulmonary disease, diabetes
Eligibility Criteria
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
Sites / Locations
- Cabinet Privé de Cardiologie - 2, rue jean jaurès
- Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet
- Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
- Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
- Cabinet privé de pneumologie - 28 avenue de Genève
- cabinet privé de médecine générale - 18, rue Louis Haase
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
medical device intervention
Arm Description
Outcomes
Primary Outcome Measures
Sensitivity and specificity of the tele-notifications
Secondary Outcome Measures
Sensitivity and specificity of the STABILITY SYSTEM INDICATORS
Specific self-administered questionnaires about Ease of Use/Usefulness/Satisfaction for each category of user
Acceptability of the system by patients regarding transmission of measured parameters
Mean number of transmission of measured parameters: real versus theoretical.
Acceptability of the system by patients: mean number of participation in virtual classroom session
Acceptability of the system by patients: mean duration of participation in virtual classroom session
Acceptability of the system by patients: mean number of consultations of modules providing medical information
Acceptability of the system by patients: cumulative time spent on consultations of modules providing medical information
Acceptability of the system by patients: mean duration of phone contacts by type (planned, for notification management, incoming)
Acceptability of the system by patients: mean number of phone contacts by type (planned, for notification management, incoming)
Acceptability of the system by patients: comparison of real planned phone contacts versus theoretical
Acceptability of the system by physicians: mean number of connections
Acceptability of the system by physicians: mean duration of connections
Feasibility of the intervention for patients
number of screening failure and prematurely withdrawal
Feasibility of the intervention for technicians
duration of intervention
Feasibility of the intervention for nurses
response time following a notification
Technological performance indices of the system: failures in data transmission
Technological performance indices of the system: inaccessibility
Technological performance indices of the system: devices deficiencies
technical problems with any medical devices (leading or not to replacement).
Number of tele-notification per patient
Frequency of tele-notifications per patient
Patient care plan: number of changes implemented by investigators.
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.
Full Information
NCT ID
NCT02803489
First Posted
May 23, 2016
Last Updated
May 11, 2017
Sponsor
Air Liquide Santé International
Collaborators
Inferential
1. Study Identification
Unique Protocol Identification Number
NCT02803489
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
inclusion rate too low & investigators enable to recruit new patients rapidly
Study Start Date
April 8, 2016 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
May 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International
Collaborators
Inferential
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases
Keywords
chronic heart failure, chronic obstructive pulmonary disease, diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
medical device intervention
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
medical device intervention
Other Intervention Name(s)
Nomhad Mobile - Nomhad Chronic
Primary Outcome Measure Information:
Title
Sensitivity and specificity of the tele-notifications
Time Frame
through study completion, an average of 11 months
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of the STABILITY SYSTEM INDICATORS
Time Frame
through study completion, an average of 11 months
Title
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
Title
Acceptability of the system by patients regarding transmission of measured parameters
Description
Mean number of transmission of measured parameters: real versus theoretical.
Time Frame
through study completion, an average of 11 months
Title
Acceptability of the system by patients: mean number of participation in virtual classroom session
Time Frame
through study completion, an average of 11 months
Title
Acceptability of the system by patients: mean duration of participation in virtual classroom session
Time Frame
through study completion, an average of 11 months
Title
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
Title
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
Title
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
Title
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
Title
Acceptability of the system by patients: comparison of real planned phone contacts versus theoretical
Time Frame
through study completion, an average of 11 months
Title
Acceptability of the system by physicians: mean number of connections
Time Frame
through study completion, an average of 11 months
Title
Acceptability of the system by physicians: mean duration of connections
Time Frame
through study completion, an average of 11 months
Title
Feasibility of the intervention for patients
Description
number of screening failure and prematurely withdrawal
Time Frame
through study completion, an average of 11 months
Title
Feasibility of the intervention for technicians
Description
duration of intervention
Time Frame
through study completion, an average of 11 months
Title
Feasibility of the intervention for nurses
Description
response time following a notification
Time Frame
through study completion, an average of 11 months
Title
Technological performance indices of the system: failures in data transmission
Time Frame
through study completion, an average of 11 months
Title
Technological performance indices of the system: inaccessibility
Time Frame
through study completion, an average of 11 months
Title
Technological performance indices of the system: devices deficiencies
Description
technical problems with any medical devices (leading or not to replacement).
Time Frame
through study completion, an average of 11 months
Title
Number of tele-notification per patient
Time Frame
through study completion, an average of 11 months
Title
Frequency of tele-notifications per patient
Time Frame
through study completion, an average of 11 months
Title
Patient care plan: number of changes implemented by investigators.
Time Frame
through study completion, an average of 11 months
Title
Clinical events including medical consultations, hospitalizations and adverse events
Description
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.
Time Frame
through study completion, an average of 11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane SH Hominal, doctor
Organizational Affiliation
Centre hospitalier d'Annecy Genevois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet Privé de Cardiologie - 2, rue jean jaurès
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
City
PRINGY Cedex
ZIP/Postal Code
74374
Country
France
Facility Name
Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
City
Pringy cedex
ZIP/Postal Code
74374
Country
France
Facility Name
Cabinet privé de pneumologie - 28 avenue de Genève
City
Saint Julien en Genevois
ZIP/Postal Code
74160
Country
France
Facility Name
cabinet privé de médecine générale - 18, rue Louis Haase
City
Thones
ZIP/Postal Code
74230
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Performance of an e-Health System
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