Evaluation of the Performance of an e-Health System

NCT02803489 | Terminated DMC

• 1 other identifier: ALMED-14-MD-051
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Chronic Diseases

Keywords

chronic heart failure; chronic obstructive pulmonary disease; diabetes

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the tele-notifications

  through study completion, an average of 11 months

Secondary Outcomes (22)

• Sensitivity and specificity of the STABILITY SYSTEM INDICATORS

  through study completion, an average of 11 months

• Specific self-administered questionnaires about Ease of Use/Usefulness/Satisfaction for each category of user

  through study completion, an average of 11 months

• Acceptability of the system by patients regarding transmission of measured parameters

  through study completion, an average of 11 months

• Acceptability of the system by patients: mean number of participation in virtual classroom session

  through study completion, an average of 11 months

• Acceptability of the system by patients: mean duration of participation in virtual classroom session

  through study completion, an average of 11 months

Study Arms (1)

medical device intervention

EXPERIMENTAL

Device: medical device intervention

Interventions

medical device intervention DEVICE

Also known as: Nomhad Mobile - Nomhad Chronic

medical device intervention

Eligibility Criteria

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

You may qualify if:

• Adult (\>18 yrs), male or female
• Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
• Able to speak and understand French to a satisfactory standard
• Having a phone land line
• Capable of understanding and accepting the study constraints

You may not qualify if:

• Pregnant or breast-feeding woman
• Institutionalized
• Having a life expectancy of less than 3 months
• Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
• Undergoing dialysis for chronic renal insufficiency
• 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
• Not covered by French Social Security
• Participating or having participated in another interventional trial within the past 30 days

Sponsors & Collaborators

• Air Liquide Santé International: lead
• Inferential: collaborator

Study Sites (6)

Cabinet Privé de Cardiologie - 2, rue jean jaurès

Annecy, 74000, France

Location

Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet

Annecy, 74000, France

Location

Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy

Pringy, 74374, France

Location

Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy

Pringy, 74374, France

Location

Cabinet privé de pneumologie - 28 avenue de Genève

Saint-Julien-en-Genevois, 74160, France

Location

cabinet privé de médecine générale - 18, rue Louis Haase

Thônes, 74230, France

Location

Related Publications (28)

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• 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.

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  PMID: 24352899 BACKGROUND

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• 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.

  PMID: 25768664 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.

  PMID: 25714962 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.

  PMID: 23680885 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.

  PMID: 24862840 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.

  PMID: 23880072 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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• 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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  BACKGROUND

• 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.

  PMID: 35275068 RESULT

MeSH Terms

Conditions

Chronic Disease; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephane SH Hominal, doctor

  Centre hospitalier d'Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 17, 2016
• Study Start: April 8, 2016
• Primary Completion: March 23, 2017
• Study Completion: May 9, 2017
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)