Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
23 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-08
Study Completion Date
2017-05-09
Brief Summary
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Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.
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Detailed Description
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The eHealth system developed in the present study is dedicated to multimorbid patients' follow-up. The medical device consists in Telemonitoring, Telenotification and Telecoaching. It aims to both increase patient autonomy, with regard to management of his/her pathologies, and facilitate coordination between health professionals.
By providing patients with tools enabling early detection of clinical worsening combined with an appropriate management, the medium and long-term objectives are to reduce hospitalizations and improve health status and quality of life of these patients at home.
In the first instance, the only objective of the present study is to evaluate the performance and feasibility of implementation of the device. This evaluation is based on a comparison between the telenotifications generated by the software and those calculated from the raw data captured by the software.
By providing patients with tools enabling early detection of clinical worsening combined with an appropriate management, the medium and long-term objectives are to reduce hospitalizations and improve health status and quality of life of these patients at home.
In the first instance, the only objective of the present study is to evaluate the performance and feasibility of implementation of the device. This evaluation is based on a comparison between the telenotifications generated by the software and those calculated from the raw data captured by the software.
Conditions
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Chronic Diseases
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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medical device intervention
Group Type
EXPERIMENTAL
medical device intervention
Intervention Type
DEVICE
Interventions
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medical device intervention
Intervention Type
DEVICE
Other Intervention Names
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Nomhad Mobile - Nomhad Chronic
Eligibility Criteria
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Inclusion Criteria
Patients presenting all the following characteristics are eligible for inclusion:
1. Adult (\>18 yrs), male or female
2. Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
3. Having been hospitalized in the CHANGE or in any other medical care center (hospital or private clinic) for acute decompensation of CHF or exacerbation of COPD at least once during the 12 months prior to inclusion
4. Able to speak and understand French to a satisfactory standard
5. Having a phone land line
6. Capable of understanding and accepting the study constraints
7. Having signed a written informed consent after a full explanation of the study by the investigator prior to inclusion
1. Adult (\>18 yrs), male or female
2. Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
3. Having been hospitalized in the CHANGE or in any other medical care center (hospital or private clinic) for acute decompensation of CHF or exacerbation of COPD at least once during the 12 months prior to inclusion
4. Able to speak and understand French to a satisfactory standard
5. Having a phone land line
6. Capable of understanding and accepting the study constraints
7. Having signed a written informed consent after a full explanation of the study by the investigator prior to inclusion
Exclusion Criteria
Patients presenting any one of the following characteristics are not eligible for inclusion:
1. Pregnant or breast-feeding woman
2. Institutionalized
3. Having a life expectancy of less than 3 months
4. Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
5. Undergoing dialysis for chronic renal insufficiency
6. Presenting a condition likely to hamper accomplishment of the study procedures, such as chronic alcoholism, drug or solvent addiction, uncontrolled psychiatric disease or severe cognitive deficiency
7. Not covered by French Social Security
8. Participating or having participated in another interventional trial within the past 30 days
1. Pregnant or breast-feeding woman
2. Institutionalized
3. Having a life expectancy of less than 3 months
4. Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
5. Undergoing dialysis for chronic renal insufficiency
6. Presenting a condition likely to hamper accomplishment of the study procedures, such as chronic alcoholism, drug or solvent addiction, uncontrolled psychiatric disease or severe cognitive deficiency
7. Not covered by French Social Security
8. Participating or having participated in another interventional trial within the past 30 days
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Inferential
INDUSTRY
Sponsor Role
collaborator
Air Liquide Santé International
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Stephane SH Hominal, doctor
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier d'Annecy Genevois
Locations
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Cabinet Privé de Cardiologie - 2, rue jean jaurès
Annecy, , France
Site Status
Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet
Annecy, , France
Site Status
Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
Pringy, , France
Site Status
Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy
Pringy, , France
Site Status
Cabinet privé de pneumologie - 28 avenue de Genève
Saint-Julien-en-Genevois, , France
Site Status
cabinet privé de médecine générale - 18, rue Louis Haase
Thônes, , France
Site Status
Countries
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France
References
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Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. doi: 10.1164/rccm.200310-1443OC. Epub 2004 Feb 27.
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Conway G. Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006 Mar;5(1):25-8. doi: 10.1097/01.hpc.0000202240.99184.81.
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Elbert NJ, van Os-Medendorp H, van Renselaar W, Ekeland AG, Hakkaart-van Roijen L, Raat H, Nijsten TE, Pasmans SG. Effectiveness and cost-effectiveness of ehealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. J Med Internet Res. 2014 Apr 16;16(4):e110. doi: 10.2196/jmir.2790.
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Marcolino MS, Maia JX, Alkmim MB, Boersma E, Ribeiro AL. Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS One. 2013 Nov 8;8(11):e79246. doi: 10.1371/journal.pone.0079246. eCollection 2013.
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BACKGROUND
Lundell S, Holmner A, Rehn B, Nyberg A, Wadell K. Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Respir Med. 2015 Jan;109(1):11-26. doi: 10.1016/j.rmed.2014.10.008. Epub 2014 Oct 27.
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Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014 Mar;68(3):369-78. doi: 10.1111/ijcp.12345. Epub 2014 Jan 28.
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BACKGROUND
Goldstein RS, O'Hoski S. Telemedicine in COPD: time to pause. Chest. 2014 May;145(5):945-949. doi: 10.1378/chest.13-1656.
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Conway A, Inglis SC, Chang AM, Horton-Breshears M, Cleland JG, Clark RA. Not all systematic reviews are systematic: a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure. J Telemed Telecare. 2013 Sep;19(6):326-37. doi: 10.1177/1357633X13503427. Epub 2013 Sep 25.
Reference Type
BACKGROUND
Nakamura N, Koga T, Iseki H. A meta-analysis of remote patient monitoring for chronic heart failure patients. J Telemed Telecare. 2014 Jan;20(1):11-7. doi: 10.1177/1357633X13517352. Epub 2013 Dec 18.
Reference Type
BACKGROUND
Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43.
Reference Type
BACKGROUND
Kitsiou S, Pare G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. J Med Internet Res. 2015 Mar 12;17(3):e63. doi: 10.2196/jmir.4174.
Reference Type
BACKGROUND
Kotb A, Cameron C, Hsieh S, Wells G. Comparative effectiveness of different forms of telemedicine for individuals with heart failure (HF): a systematic review and network meta-analysis. PLoS One. 2015 Feb 25;10(2):e0118681. doi: 10.1371/journal.pone.0118681. eCollection 2015.
Reference Type
BACKGROUND
Pandor A, Gomersall T, Stevens JW, Wang J, Al-Mohammad A, Bakhai A, Cleland JG, Cowie MR, Wong R. Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis. Heart. 2013 Dec;99(23):1717-26. doi: 10.1136/heartjnl-2013-303811. Epub 2013 May 16.
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BACKGROUND
Feltner C, Jones CD, Cene CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJ, Arvanitis M, Lohr KN, Middleton JC, Jonas DE. Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med. 2014 Jun 3;160(11):774-84. doi: 10.7326/M14-0083.
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BACKGROUND
Kitsiou S, Pare G, Jaana M. Systematic reviews and meta-analyses of home telemonitoring interventions for patients with chronic diseases: a critical assessment of their methodological quality. J Med Internet Res. 2013 Jul 23;15(7):e150. doi: 10.2196/jmir.2770.
Reference Type
BACKGROUND
Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736-71. doi: 10.1016/j.ijmedinf.2010.08.006.
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Ekeland AG, Bowes A, Flottorp S. Methodologies for assessing telemedicine: a systematic review of reviews. Int J Med Inform. 2012 Jan;81(1):1-11. doi: 10.1016/j.ijmedinf.2011.10.009. Epub 2011 Nov 21.
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Conway A, Inglis SC, Clark RA. Effective technologies for noninvasive remote monitoring in heart failure. Telemed J E Health. 2014 Jun;20(6):531-8. doi: 10.1089/tmj.2013.0267. Epub 2014 Apr 14.
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Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012 Jul 7;380(9836):37-43. doi: 10.1016/S0140-6736(12)60240-2. Epub 2012 May 10.
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Lefevre T, d'Ivernois JF, De Andrade V, Crozet C, Lombrail P, Gagnayre R. What do we mean by multimorbidity? An analysis of the literature on multimorbidity measures, associated factors, and impact on health services organization. Rev Epidemiol Sante Publique. 2014 Oct;62(5):305-14. doi: 10.1016/j.respe.2014.09.002. Epub 2014 Oct 25.
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Smith SM, Soubhi H, Fortin M, Hudon C, O'Dowd T. Managing patients with multimorbidity: systematic review of interventions in primary care and community settings. BMJ. 2012 Sep 3;345:e5205. doi: 10.1136/bmj.e5205.
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Fabbri LM, Boyd C, Boschetto P, Rabe KF, Buist AS, Yawn B, Leff B, Kent DM, Schunemann HJ; ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development. How to integrate multiple comorbidities in guideline development: article 10 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report. Proc Am Thorac Soc. 2012 Dec;9(5):274-81. doi: 10.1513/pats.201208-063ST.
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Onder G, Palmer K, Navickas R, Jureviciene E, Mammarella F, Strandzheva M, Mannucci P, Pecorelli S, Marengoni A; Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS). Time to face the challenge of multimorbidity. A European perspective from the joint action on chronic diseases and promoting healthy ageing across the life cycle (JA-CHRODIS). Eur J Intern Med. 2015 Apr;26(3):157-9. doi: 10.1016/j.ejim.2015.02.020. Epub 2015 Mar 18.
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Martin-Lesende I, Orruno E, Bilbao A, Vergara I, Cairo MC, Bayon JC, Reviriego E, Romo MI, Larranaga J, Asua J, Abad R, Recalde E. Impact of telemonitoring home care patients with heart failure or chronic lung disease from primary care on healthcare resource use (the TELBIL study randomised controlled trial). BMC Health Serv Res. 2013 Mar 28;13:118. doi: 10.1186/1472-6963-13-118.
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Chow SK, Wong FK. A randomized controlled trial of a nurse-led case management programme for hospital-discharged older adults with co-morbidities. J Adv Nurs. 2014 Oct;70(10):2257-71. doi: 10.1111/jan.12375. Epub 2014 Mar 12.
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Prochaska JO, DiClemente CC. Transtheorical therapy toward a more integrative model of change. Psychotherapy: Theory, Research and Practice, 1982;19(3):276-287
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Chacornac M, Faoro A, Texereau J, Billoet C, Hominal S. Performance of an eHealth (NOMHAD) System Comprising Telemonitoring, Telenotification, and Telecoaching for Patients With Multimorbidity: Proof-of-Concept Study. JMIR Form Res. 2022 Mar 11;6(3):e32205. doi: 10.2196/32205.
Reference Type
RESULT
Other Identifiers
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ALMED-14-MD-051
Identifier Type: -
Identifier Source: org_study_id
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