Back to results

Batch n ° 2 of the Public Market Evaluation "Medico-economic Demonstrator IsereADOM" (CardIC)

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Innovative Supported

About this trial

This is an interventional health services research trial for Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

Patient diagnosed with heart failure confirmed by a cardiologist ;
Patient with functional NYHA II, III, IV staining ;
Patient domiciled in the department of Isère ;
Patient who can be followed regularly for 6 months ;
Patient who can benefit from RESIC-type health education ;
Presence of a caregiver referent of proximity (family or other) according to appreciation of the investigating doctor in case of cognitive disorders ;
Patient affiliated with social security or beneficiary of such a scheme ;
Patient able to read, write and understand French ;
Patient having signed informed consent to participate.

Exclusion Criteria:

Patient with peritoneal dialysis or haemofiltration ;
Patient with severe co-morbidity with poor short-term prognosis: mortality < 6 months ;
Patient with future surgical etiologic treatment: prosthetic valve, revascularization procedure, TAVI or MITRACLIP ;
Patient residing in a nursing home or institution for dependent person ;
Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all persons protected: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject of a legal protection measure).

Sites / Locations

Groupe Hospitalier Mutualiste
CHU Grenoble-Alpes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Innovative supported

conventional supported

Arm Description

In addition to usual care, patients benefit from connected tools (overpoise, sphygmomanometer...), physical activity, a strong accompaniment with a referent person

Patients benefit from usual care

Outcomes

Primary Outcome Measures

the effectiveness of a service package compared to conventional follow-up in people with heart failure.

The outcome measure is the number of hospitalization

Secondary Outcome Measures

Full Information

NCT ID

NCT03457623

First Posted

February 28, 2018

Last Updated

May 25, 2020

Sponsor

University Hospital, Grenoble

1. Study Identification

Unique Protocol Identification Number

NCT03457623

Brief Title

Batch n ° 2 of the Public Market Evaluation "Medico-economic Demonstrator IsereADOM"

Acronym

CardIC

Official Title

Medico-economic Evaluation of a "IsereADOM" Package of Services Versus Conventional Health and Social Monitoring, in the Care of a Population of People With Heart Failure in Isère.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

November 20, 2017 (Actual)

Primary Completion Date

November 15, 2019 (Actual)

Study Completion Date

November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this study is to evaluate the health and social benefit of innovative management - IsereADOM - versus conventional follow-up in patients with heart failure. There is a medico-economic goal too, is to perform a cost-utility analysis of the service bundle (IsereADOM) versus conventional 6-month community-based follow-up in a population with heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Innovative supported

Arm Type

Experimental

Arm Description

In addition to usual care, patients benefit from connected tools (overpoise, sphygmomanometer...), physical activity, a strong accompaniment with a referent person

Arm Title

conventional supported

Arm Type

No Intervention

Arm Description

Patients benefit from usual care

Intervention Type

Other

Intervention Name(s)

Innovative Supported

Intervention Description

addition of connected tools and stronger accompaniment to improve quality of life

Primary Outcome Measure Information:

Title

the effectiveness of a service package compared to conventional follow-up in people with heart failure.

Description

The outcome measure is the number of hospitalization

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient diagnosed with heart failure confirmed by a cardiologist ; Patient with functional NYHA II, III, IV staining ; Patient domiciled in the department of Isère ; Patient who can be followed regularly for 6 months ; Patient who can benefit from RESIC-type health education ; Presence of a caregiver referent of proximity (family or other) according to appreciation of the investigating doctor in case of cognitive disorders ; Patient affiliated with social security or beneficiary of such a scheme ; Patient able to read, write and understand French ; Patient having signed informed consent to participate. Exclusion Criteria: Patient with peritoneal dialysis or haemofiltration ; Patient with severe co-morbidity with poor short-term prognosis: mortality < 6 months ; Patient with future surgical etiologic treatment: prosthetic valve, revascularization procedure, TAVI or MITRACLIP ; Patient residing in a nursing home or institution for dependent person ; Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all persons protected: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject of a legal protection measure).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muriel SALVAT, MD

Organizational Affiliation

CHU Grenoble Alpes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Groupe Hospitalier Mutualiste

City

Grenoble

ZIP/Postal Code

38000

Country

France

Facility Name

CHU Grenoble-Alpes

City

Grenoble

ZIP/Postal Code

38043

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17132052

Citation

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.

Results Reference

background

PubMed Identifier

22825412

Citation

Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. No abstract available.

Results Reference

background

PubMed Identifier

22828712

Citation

McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology; Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. No abstract available. Erratum In: Eur J Heart Fail. 2013 Mar;15(3):361-2.

Results Reference

background

PubMed Identifier

22811548

Citation

Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.

Results Reference

background

PubMed Identifier

22972058

Citation

Takeda A, Taylor SJ, Taylor RS, Khan F, Krum H, Underwood M. Clinical service organisation for heart failure. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD002752. doi: 10.1002/14651858.CD002752.pub3.

Results Reference

background

PubMed Identifier

20031870

Citation

Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.

Results Reference

background

PubMed Identifier

20858878

Citation

Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.

Results Reference

background

PubMed Identifier

15497198

Citation

Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944.

Results Reference

background

Learn more about this trial

Batch n ° 2 of the Public Market Evaluation "Medico-economic Demonstrator IsereADOM"

We'll reach out to this number within 24 hrs