Evaluation of the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer

NCT ID: NCT03330730

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2019-06-17

Brief Summary

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

Detailed Description

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:

• Retired persons with no proven loss of autonomy;
• Users with loss of autonomy at risk of falling;
• Cardiac insufficiency;
• Patients with cancer.

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.

Conditions

Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

IsereADOM service package

Intervention Type: OTHER

Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching

Control

Patients with oncological follow up only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IsereADOM service package

Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age > or = 18 years old at the time of signature of informed consent form
• patient with solid or hematologic tumor under treatment for cancer at the time of inclusion
• Patient managed in a medical emergency context in the 2 weeks prior to inclusion
• Patient living in Isère department (area of coverage of experiment)
• ECOG Performance index < or = 3
• patient with a life expectancy of 6 months or more
• patient with social security system
• patient able to read, write and understand French
• patient with signed informed consent

Exclusion Criteria

• Patient included in clinical trial evaluating early stage therapeutic innovation with pharmacokinetic sampling
• Patients with follow-up in Hospitalization at Home at the end of the hospitalization for inclusion
• Patient without help "referent" in the entourage (spouse, family, friend ...)
• Patient residing in Elderly Accommodation (EHPAD) or in any other institution for dependent persons
• Patient who is homeless or living in a home that does not allow the installation of the necessary equipment
• Patient with severe cognitive impairment, defined by score at Mini Mental State Examination (MMSE)< 23/30
• Patient unable to comply (or unwilling to comply) with follow-up of the study for the duration of participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conseil general de l'Isere

UNKNOWN

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, France

CHU Grenoble Alpes

Grenoble, , France

Institut Daniel Hollard

Grenoble, , France

Countries

France

Other Identifiers

IsereADOM

Identifier Type: -

Identifier Source: org_study_id