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Efficacy of PRADO Heart Failure in Occitania (PRADO-IC)

Primary Purpose

Heart Failure

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PRADO-IC
No intervervention Usual Care
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Heart Failure, Care pathway, Transition program, Efficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Hospitalization for heart failure
  • Subject living at home
  • Informed consent

Exclusion criteria:

  • discharge to a rehabilitation clinic or to medical home for elderly people
  • subject without health insurance
  • terminal kidney failure
  • programmed heart surgery
  • waiting for heart transplantation
  • psycho-cognitive impairment
  • patient not autonomous for mobility at home
  • supportive care
  • planned move to medical home for elderly people in the coming 6 months
  • no fluent french
  • not able to provide informed consent
  • participating to other study

Sites / Locations

  • CHU Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PRADO-IC

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Cost-efficacy ratio
Cost to avoid an hospitalization for heart failure

Secondary Outcome Measures

Cost-utility ratio
Cost will be performed from the society perspective. Utility will be derived from the French EQ5D, measured at 0, 6 and 12 months
Number of hospitalization for heart failure
Hospitalizations for heart failure will be defined using claim data.
Number of all causes hospitalization
Rate of death from cardiovascular disease
Number of general practitionner
Claim data
Number of cardiologist visits
Claim data

Full Information

First Posted
December 26, 2017
Last Updated
October 4, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03396081
Brief Title
Efficacy of PRADO Heart Failure in Occitania
Acronym
PRADO-IC
Official Title
Efficacy of PRADO Heart Failure in Occitania
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

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

5. Study Description

Brief Summary
Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by the Health Insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of PRADO began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged. This study was of epidemiological type, comparative before-elsewhere. The difficulty of controlling for confounders in this type of study limits the scope of these conclusions. The efficacy hypothesis of PRADO IC is therefore always posed in the French context

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Care pathway, Transition program, Efficiency

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRADO-IC
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
PRADO-IC
Intervention Description
Help of administrative employees to schedule the first medical visits after an hospitalization for heart failure. Home nurse's visiting program, during 2 to 6 months after the hospitalization for heart failure.
Intervention Type
Behavioral
Intervention Name(s)
No intervervention Usual Care
Intervention Description
Advices about the care pathway, provided by care givers. Prescription of home nurse's visits if needed.
Primary Outcome Measure Information:
Title
Cost-efficacy ratio
Description
Cost to avoid an hospitalization for heart failure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cost-utility ratio
Description
Cost will be performed from the society perspective. Utility will be derived from the French EQ5D, measured at 0, 6 and 12 months
Time Frame
12 months
Title
Number of hospitalization for heart failure
Description
Hospitalizations for heart failure will be defined using claim data.
Time Frame
12 months
Title
Number of all causes hospitalization
Time Frame
12 months
Title
Rate of death from cardiovascular disease
Time Frame
12 months
Title
Number of general practitionner
Description
Claim data
Time Frame
12 months
Title
Number of cardiologist visits
Description
Claim data
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Hospitalization for heart failure Subject living at home Informed consent Exclusion criteria: discharge to a rehabilitation clinic or to medical home for elderly people subject without health insurance terminal kidney failure programmed heart surgery waiting for heart transplantation psycho-cognitive impairment patient not autonomous for mobility at home supportive care planned move to medical home for elderly people in the coming 6 months no fluent french not able to provide informed consent participating to other study
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Efficacy of PRADO Heart Failure in Occitania

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