IsereADOM service package
OtherObjects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching
NCT Number: NCT03330730
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Centre Léon Bérard, Lyon, Auvergne-Rhône-Alpes, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching
Time frame: 6 months
Comparison of the mean number of unplanned hospitalizations observed within 6 months of randomization.
Time frame: 6 months
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)
Time frame: 6 months
Calculation of incremental costs and saved costs with the experimental strategy
Time frame: 6 months
Evaluation in both arms of loss of autonomy with questionnaires "Activities of Daily Living"
Time frame: 6 months
Evaluation in both arms of loss of autonomy with questionnaires "Instrumental Activities of Daily Living"
Time frame: 6 months
Evaluation in both arms of anxiety with questionnaire "Hospital Anxiety and Depression scale"
Time frame: 6 months
Evaluation in both arms of depression with questionnaire "Hospital Anxiety and Depression scale"
Time frame: 6 months
Evaluation in both arms of nutritional status by measuring albumin rate
Time frame: 6 months
Evaluation in both arms of nutritional status by measuring prealbumin rate
Time frame: 6 months
Evaluation in both arms of nutritional status by measuring weight
Time frame: 6 months
Evaluation in both arms of the quality of life with questionnaire "EuroQoL 5 Dimensions 5 Levels"
Time frame: 6 months
Description in both arms of home care with questionnaire "RUD" for the natural caregivers
Time frame: 6 months
Evaluation in both arms of consumption of unprogrammed care with patient's booklet
Time frame: 6 months
Evaluation in both arms of overall survival
Time frame: 6 months
Characterizing unjustified hospitalizations, to determine predictive factors for the efficiency of experimental management, progression-Free Survival
Time frame: 6 months
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
Time frame: 6 months
Evaluation of the proportion of sentinel nurses asked to participate in the study
Time frame: 6 months
Evaluation of the number of calls and the number of connections to the telephone and Internet platforms
Time frame: 6 months
Evaluation of the number of refusal to participate.
Time frame: 6 months
Evaluation of the causes of refusal to participate.
Time frame: 6 months
Centre Leon Berard
Other
A Randomized, Controlled, Multicenter, Prospective, Open Study Evaluating the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer
Acronym: IsereADOM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02423057
Neoplasms, Solid Tumors
Bethesda, Maryland, United States
View Trial DetailsNCT03872778
Neoplasms
Duarte, California, United States
View Trial DetailsNCT04618913
Cardiovascular Diseases, Embolism
London, United Kingdom
View Trial DetailsNCT05256888
Behavior, Diet Therapy
Baltimore, Maryland, United States
View Trial Details