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inclusion rate too low & investigators enable to recruit new patients rapidly
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| Name | Class |
|---|---|
| Inferential | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medical device intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical device intervention | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the tele-notifications | through study completion, an average of 11 months |
| 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 |
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Inclusion Criteria:
Patients presenting all the following characteristics are eligible for inclusion:
Exclusion Criteria:
Patients presenting any one of the following characteristics are not eligible for inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Stephane SH Hominal, doctor | Centre hospitalier d'Annecy Genevois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Privé de Cardiologie - 2, rue jean jaurès | Annecy | 74000 | France | |||
| Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14990395 | Background | Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. doi: 10.1164/rccm.200310-1443OC. Epub 2004 Feb 27. | |
| 18340214 | Background | Conway G. Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006 Mar;5(1):25-8. doi: 10.1097/01.hpc.0000202240.99184.81. |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
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| 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 |
| Annecy |
| 74000 |
| France |
| Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy | Pringy | 74374 | France |
| Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy | Pringy | 74374 | France |
| Cabinet privé de pneumologie - 28 avenue de Genève | Saint-Julien-en-Genevois | 74160 | France |
| cabinet privé de médecine générale - 18, rue Louis Haase | Thônes | 74230 | France |
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| 35275068 | Result | Chacornac M, Faoro A, Texereau J, Billoet C, Hominal S. Performance of an eHealth (NOMHAD) System Comprising Telemonitoring, Telenotification, and Telecoaching for Patients With Multimorbidity: Proof-of-Concept Study. JMIR Form Res. 2022 Mar 11;6(3):e32205. doi: 10.2196/32205. |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |