Chronic Diseases
Conditions
Keywords
chronic heart failure, chronic obstructive pulmonary disease, diabetes
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.
Interventions
DEVICEmedical device intervention
Sponsors
Inferential
Air Liquide Santé International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the tele-notifications | through study completion, an average of 11 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | through study completion, an average of 11 months | Mean number of transmission of measured parameters: real versus theoretical. |
| 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 | — |
| Sensitivity and specificity of the STABILITY SYSTEM INDICATORS | through study completion, an average of 11 months | — |
| Feasibility of the intervention for patients | through study completion, an average of 11 months | number of screening failure and prematurely withdrawal |
| Feasibility of the intervention for technicians | through study completion, an average of 11 months | duration of intervention |
| Feasibility of the intervention for nurses | through study completion, an average of 11 months | response time following a notification |
| 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 | through study completion, an average of 11 months | technical problems with any medical devices (leading or not to replacement). |
| 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 | 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. |
| Acceptability of the system by physicians: mean duration of connections | through study completion, an average of 11 months | — |
Countries
France
Outcome results
None listed