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

December 12, 2019 updated by: Centre Leon Berard

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • Chu Grenoble Alpes
      • Grenoble, France
        • Institut Daniel Hollard
    • Rhône-Alpes
      • Lyon, Rhône-Alpes, France, 69008
        • Centre Léon Bérard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: IsereADOM service package
Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching
No Intervention: Control
Patients with oncological follow up only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of the effectiveness and efficiency of innovative care with the IsereADOM home-care service package versus standard support
Time Frame: 6 months
Comparison of the mean number of unplanned hospitalizations observed within 6 months of randomization.
6 months
Incremental Cost-Utility Ratio comparison
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)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Budget impact analysis
Time Frame: 6 months
Calculation of incremental costs and saved costs with the experimental strategy
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of loss of autonomy with questionnaires "Activities of Daily Living"
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of loss of autonomy with questionnaires "Instrumental Activities of Daily Living"
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of anxiety with questionnaire "Hospital Anxiety and Depression scale"
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of depression with questionnaire "Hospital Anxiety and Depression scale"
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of nutritional status by measuring albumin rate
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of nutritional status by measuring prealbumin rate
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of nutritional status by measuring weight
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of the quality of life with questionnaire "EuroQoL 5 Dimensions 5 Levels"
6 months
Patient's condition evaluation
Time Frame: 6 months
Description in both arms of home care with questionnaire "RUD" for the natural caregivers
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of consumption of unprogrammed care with patient's booklet
6 months
Patient's condition evaluation
Time Frame: 6 months
Evaluation in both arms of overall survival
6 months
Patient's condition evaluation
Time Frame: 6 months
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
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
6 months
Evaluation of IsereADOM home-care service package impact
Time Frame: 6 months
Evaluation of the proportion of sentinel nurses asked to participate in the study
6 months
Evaluation of IsereADOM home-care service package impact
Time Frame: 6 months
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
Time Frame: 6 months
Evaluation of the number of refusal to participate.
6 months
Evaluation of IsereADOM home-care service package impact
Time Frame: 6 months
Evaluation of the causes of refusal to participate.
6 months
Analysis of the geographical factors predicting the effectiveness of the package
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Leon Berard

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Conseil general de l'Isere

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IsereADOM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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