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

NCT03330730 | Completed DMC

• 1 other identifier: IsereADOM
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Comparison of the effectiveness and efficiency of innovative care with the IsereADOM home-care service package versus standard support

  Comparison of the mean number of unplanned hospitalizations observed within 6 months of randomization.

  6 months

• Incremental Cost-Utility Ratio comparison

  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 Outcomes (19)

• Budget impact analysis

  6 months

• Patient's condition evaluation

  6 months

• Patient's condition evaluation

  6 months

• Patient's condition evaluation

  6 months

• Patient's condition evaluation

  6 months

Study Arms (2)

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

Control

NO INTERVENTION

Patients with oncological follow up only

Interventions

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> or = 18 years old at the time of signature of informed consent form
• 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

You may not qualify if:

• Patient included in clinical trial evaluating early stage therapeutic innovation with pharmacokinetic sampling
• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• Conseil general de l'Isere: collaborator

Study Sites (3)

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, 69008, France

Location

CHU Grenoble Alpes

Grenoble, France

Location

Institut Daniel Hollard

Grenoble, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 6, 2017
• Study Start: January 11, 2018
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

FR (3)