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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330730
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
Conseil general de l'Isere
Information provided by (Responsible Party):
Centre Leon Berard

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

Condition or disease Intervention/treatment Phase
Neoplasms Other: IsereADOM service package Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : January 11, 2018
Actual Primary Completion Date : June 17, 2019
Actual Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330730


Locations
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France
Centre Léon Bérard
Lyon, Rhône-Alpes, France, 69008
CHU Grenoble Alpes
Grenoble, France
Institut Daniel Hollard
Grenoble, France
Sponsors and Collaborators
Centre Leon Berard
Conseil general de l'Isere
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT03330730    
Other Study ID Numbers: IsereADOM
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No