CompletedNCT03457623CardICUpdated May 27, 2020

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

An interventional study of Innovative Supported in Heart Failure, sponsored by University Hospital, Grenoble. Completed at 2 sites in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Health services research

Phase: Not applicable
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 60 Years and older
Sex: All

Study 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.

Conditions studied

Heart Failure

Browse trials for

Heart Failure 5,681

Who can participate

Ages eligible: 60 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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).

Study design

Phase: Not applicable
Primary purpose: Health services research
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 66 participants (actual)

Study arms

Experimental
Innovative supported
In addition to usual care, patients benefit from connected tools (overpoise, sphygmomanometer...), physical activity, a strong accompaniment with a referent person
Other: Innovative Supported
No intervention
conventional supported
Patients benefit from usual care

Interventions

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

What researchers measure

Primary outcomes

the effectiveness of a service package compared to conventional follow-up in people with heart failure.
The outcome measure is the number of hospitalization
Time frame: 6 months

Study locations

2 sites

Groupe Hospitalier Mutualiste
Grenoble, 38000, France
CHU Grenoble-Alpes
Grenoble, 38043, France

References and documents

Publications

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. PubMed 17132052 ↗
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. PubMed 22825412 ↗
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. PubMed 22828712 ↗
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. PubMed 22811548 ↗
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. PubMed 22972058 ↗
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. PubMed 20031870 ↗
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. PubMed 20858878 ↗
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. PubMed 15497198 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03457623
Lead sponsor: University Hospital, Grenoble
Responsible party: Sponsor
First posted: Mar 7, 2018
Start date: Nov 20, 2017
Primary completion: Nov 15, 2019
Completion: Nov 15, 2019
Last update: May 27, 2020

Study contacts

Muriel SALVAT, MD

principal investigator · CHU Grenoble Alpes

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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