Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Conseil general de l'Isere | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The main objective of the project is to compare the effectiveness and efficiency of innovative care through the IsereADOM home-care service package versus standard care in the prevention of unplanned hospitalizations in patients with cancer treatment. In accordance with the recommendations of the French High Authority of Health (HAS), a cost-utility analysis (ACU) will be implemented
Specific management of cancer patients involves carrying out often heavy treatments (surgery, chemotherapy, radiotherapy, interventional radiology, etc.) during which close coaching is necessary. In spite of this adapted follow-up, the natural evolution of the disease and the management of treatment tolerance make these patients a frail population, sometimes isolated, for which admission to emergency services and admission to full hospitalization can be required.
This trial will use a service package at home named IsereADOM, currently in the development phase in the management of 4 types of populations:
This service package is based on the identification of a person of proximity, called "sentinel referent". This person, in charge of monitoring the patient at his / her home, has access to various connected tools installed at the patient's home (scales, tensiometer ...) as well as computer solutions enabling the sharing of information with the different actors in the management of the patient.
In addition, the patient benefits from motivational coaching based on investigator's recommendation and telephone and internet information platforms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients with oncological follow up and home-care service package IsereADOM: Objects connected to patients' home (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer) with graduated protocol for medical platform support. Digital linkbook (different from the medical file) accessible to the patient and the standard care actors. Referent sentinel: a field actor to coordinate the care. Preferred contact of the patient outside the center Motivational coaching: 1 to 2 axes to be defined by the investigator among the following axes (physical activity, nutrition and hydration, drug compliance, medical follow-up, chronic and moral pain, acceptance of the disease and treatments). |
|
| Control | No Intervention | Patients with oncological follow up only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IsereADOM service package | Other | Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the effectiveness and efficiency of innovative care with the IsereADOM home-care service package versus standard support | Comparison of the mean number of unplanned hospitalizations observed within 6 months of randomization. | 6 months |
| Incremental Cost-Utility Ratio comparison | Evaluation of the costs of the home-care service package; Assessment of health care consumption from a community perspective; Calculation of the years of life gained in good health (QALY) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Budget impact analysis | Calculation of incremental costs and saved costs with the experimental strategy | 6 months |
| Patient's condition evaluation | Evaluation in both arms of loss of autonomy with questionnaires "Activities of Daily Living" |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | Auvergne-Rhône-Alpes | 69008 | France | ||
| CHU Grenoble Alpes |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| Patient's condition evaluation | Evaluation in both arms of loss of autonomy with questionnaires "Instrumental Activities of Daily Living" | 6 months |
| Patient's condition evaluation | Evaluation in both arms of anxiety with questionnaire "Hospital Anxiety and Depression scale" | 6 months |
| Patient's condition evaluation | Evaluation in both arms of depression with questionnaire "Hospital Anxiety and Depression scale" | 6 months |
| Patient's condition evaluation | Evaluation in both arms of nutritional status by measuring albumin rate | 6 months |
| Patient's condition evaluation | Evaluation in both arms of nutritional status by measuring prealbumin rate | 6 months |
| Patient's condition evaluation | Evaluation in both arms of nutritional status by measuring weight | 6 months |
| Patient's condition evaluation | Evaluation in both arms of the quality of life with questionnaire "EuroQoL 5 Dimensions 5 Levels" | 6 months |
| Patient's condition evaluation | Description in both arms of home care with questionnaire "RUD" for the natural caregivers | 6 months |
| Patient's condition evaluation | Evaluation in both arms of consumption of unprogrammed care with patient's booklet | 6 months |
| Patient's condition evaluation | Evaluation in both arms of overall survival | 6 months |
| Patient's condition evaluation | Characterizing unjustified hospitalizations, to determine predictive factors for the efficiency of experimental management, progression-Free Survival | 6 months |
| Evaluation of IsereADOM home-care service package impact | Evaluation of the duration of setting up the experimental procedure by measuring the delay between the randomisation and the complete installation of the home-care service package at the patient's home | 6 months |
| Evaluation of IsereADOM home-care service package impact | Evaluation of the proportion of sentinel nurses asked to participate in the study | 6 months |
| Evaluation of IsereADOM home-care service package impact | Evaluation of the number of calls and the number of connections to the telephone and Internet platforms | 6 months |
| Evaluation of IsereADOM home-care service package impact | Evaluation of the number of refusal to participate. | 6 months |
| Evaluation of IsereADOM home-care service package impact | Evaluation of the causes of refusal to participate. | 6 months |
| Analysis of the geographical factors predicting the effectiveness of the package | 6 months |
| Grenoble |
| France |
| Institut Daniel Hollard | Grenoble | France |