Skip to main content
OpenTrials
Completed

NCT Number: NCT03330730

Evaluation of 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard, Lyon, Auvergne-Rhône-Alpes, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. Budget impact analysis

    Time frame: 6 months

    Calculation of incremental costs and saved costs with the experimental strategy

  2. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of loss of autonomy with questionnaires "Activities of Daily Living"

  3. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of loss of autonomy with questionnaires "Instrumental Activities of Daily Living"

  4. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of anxiety with questionnaire "Hospital Anxiety and Depression scale"

  5. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of depression with questionnaire "Hospital Anxiety and Depression scale"

  6. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of nutritional status by measuring albumin rate

  7. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of nutritional status by measuring prealbumin rate

  8. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of nutritional status by measuring weight

  9. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of the quality of life with questionnaire "EuroQoL 5 Dimensions 5 Levels"

  10. Patient's condition evaluation

    Time frame: 6 months

    Description in both arms of home care with questionnaire "RUD" for the natural caregivers

  11. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of consumption of unprogrammed care with patient's booklet

  12. Patient's condition evaluation

    Time frame: 6 months

    Evaluation in both arms of overall survival

  13. Patient's condition evaluation

    Time frame: 6 months

    Characterizing unjustified hospitalizations, to determine predictive factors for the efficiency of experimental management, progression-Free Survival

  14. 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

  15. 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

  16. 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

  17. Evaluation of IsereADOM home-care service package impact

    Time frame: 6 months

    Evaluation of the number of refusal to participate.

  18. Evaluation of IsereADOM home-care service package impact

    Time frame: 6 months

    Evaluation of the causes of refusal to participate.

  19. Analysis of the geographical factors predicting the effectiveness of the package

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Conseil general de l'Isere

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Dec 13, 2019

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.