Evaluation of the Performance of an e-Health System

Chronic Diseases Clinical Trial

Official title:

Evaluation of the Performance of an e-Health System Comprising Tele-monitoring / Tele-notification and Tele-coaching in Ambulatory Multi-morbid Adult Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02803489
• Other study ID #: ALMED-14-MD-051
• Status: Terminated
• Phase: N/A
• First received: May 23, 2016
• Last updated: May 11, 2017
• Start date: April 8, 2016
• Est. completion date: May 9, 2017

Study information

• Verified date: April 2017
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 9, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

Device:
• medical device intervention

Locations

Country	Name	City	State
France	Cabinet Privé de Cardiologie - 2, rue jean jaurès	Annecy
France	Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet	Annecy
France	Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy	PRINGY Cedex
France	Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy	Pringy cedex
France	Cabinet privé de pneumologie - 28 avenue de Genève	Saint Julien en Genevois
France	cabinet privé de médecine générale - 18, rue Louis Haase	Thones

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Santé International	INFERENTIAL

Country where clinical trial is conducted

France, 

References & Publications (27)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Fabbri LM, Boyd C, Boschetto P, Rabe KF, Buist AS, Yawn B, Leff B, Kent DM, Schünemann 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. Review. — View Citation

Feltner C, Jones CD, Cené 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. Review. — View Citation

Goldstein RS, O'Hoski S. Telemedicine in COPD: time to pause. Chest. 2014 May;145(5):945-9. doi: 10.1378/chest.13-1656. Review. — View Citation

Kitsiou S, Paré 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. Review. — View Citation

Kitsiou S, Paré 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. Review. Erratum in: J Med Internet Res. 2013;15(11):e253. — View Citation

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. Review. — View Citation

Lefèvre 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. Review. — View Citation

Lundell S, Holmner Å, 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. Review. — View Citation

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. — View Citation

Martín-Lesende I, Orruño E, Bilbao A, Vergara I, Cairo MC, Bayón JC, Reviriego E, Romo MI, Larrañaga 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Prochaska JO, DiClemente CC. Transtheorical therapy toward a more integrative model of change. Psychotherapy: Theory, Research and Practice, 1982;19(3):276-287

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. Review. — View Citation

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. Review. — View Citation

Sutherland D, Hayter M. Structured review: evaluating the effectiveness of nurse case managers in improving health outcomes in three major chronic diseases. J Clin Nurs. 2009 Nov;18(21):2978-92. doi: 10.1111/j.1365-2702.2009.02900.x. Epub 2009 Sep 11. Review. — View Citation

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. Epub 2004 Feb 27. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the tele-notifications		through study completion, an average of 11 months
Secondary	Sensitivity and specificity of the STABILITY SYSTEM INDICATORS		through study completion, an average of 11 months
Secondary	Specific self-administered questionnaires about Ease of Use/Usefulness/Satisfaction for each category of user		through study completion, an average of 11 months
Secondary	Acceptability of the system by patients regarding transmission of measured parameters	Mean number of transmission of measured parameters: real versus theoretical.	through study completion, an average of 11 months
Secondary	Acceptability of the system by patients: mean number of participation in virtual classroom session		through study completion, an average of 11 months
Secondary	Acceptability of the system by patients: mean duration of participation in virtual classroom session		through study completion, an average of 11 months
Secondary	Acceptability of the system by patients: mean number of consultations of modules providing medical information		through study completion, an average of 11 months
Secondary	Acceptability of the system by patients: cumulative time spent on consultations of modules providing medical information		through study completion, an average of 11 months
Secondary	Acceptability of the system by patients: mean duration of phone contacts by type (planned, for notification management, incoming)		through study completion, an average of 11 months
Secondary	Acceptability of the system by patients: mean number of phone contacts by type (planned, for notification management, incoming)		through study completion, an average of 11 months
Secondary	Acceptability of the system by patients: comparison of real planned phone contacts versus theoretical		through study completion, an average of 11 months
Secondary	Acceptability of the system by physicians: mean number of connections		through study completion, an average of 11 months
Secondary	Acceptability of the system by physicians: mean duration of connections		through study completion, an average of 11 months
Secondary	Feasibility of the intervention for patients	number of screening failure and prematurely withdrawal	through study completion, an average of 11 months
Secondary	Feasibility of the intervention for technicians	duration of intervention	through study completion, an average of 11 months
Secondary	Feasibility of the intervention for nurses	response time following a notification	through study completion, an average of 11 months
Secondary	Technological performance indices of the system: failures in data transmission		through study completion, an average of 11 months
Secondary	Technological performance indices of the system: inaccessibility		through study completion, an average of 11 months
Secondary	Technological performance indices of the system: devices deficiencies	technical problems with any medical devices (leading or not to replacement).	through study completion, an average of 11 months
Secondary	Number of tele-notification per patient		through study completion, an average of 11 months
Secondary	Frequency of tele-notifications per patient		through study completion, an average of 11 months
Secondary	Patient care plan: number of changes implemented by investigators.		through study completion, an average of 11 months
Secondary	Clinical events including medical consultations, hospitalizations and adverse events	Overall description of medical consultations, hospitalizations and adverse events. For adverse events, in addition, evaluation of seriousness and causal relationship with the medical device of the study.	through study completion, an average of 11 months

External Links

•   Agence national d'appui à la performance des établissements de santé et médico-sociaux. La télémédecine en action: 25 projets passés à la loupe. Un éclairage pour le déploiement national. Tome 2: monographies. Paris: ANAP, 2012
•   agence nationale d'appui à la performance des établissements de santé et médico-sociaux. La télémédecine en action: 25 projets passés à la loupe. Un éclairage pour le déploiement national. Tome 1: les grands enseignements. Paris: ANAP; 2012.
•   Caisse Nationale d'Assurance Maladie, Communiqué de Presse, 4 mai 2015. L'Assurance Maladie lance l'expérimentation du programme d'accompagnement du retour à domicile (Prado) pour les patients hospitalisés pour bronchopneumopathie chronique obstructive.
•   Caisse Nationale d'Assurance Maladie. Programme d'Accompagnement du Retour à Domicile (PRADO), mars 2014.
•   Caisse Nationale d'Assurance Maladie. Programme d'Accompagnement du Retour à Domicile (PRADO). Bilan et perspectives pour les Soins de Suite et de Réadaptation. Prise en charge ambulatoire, 12 mars 2015.
•   Haute Autorité de Santé. Comment prévenir les ré-hospitalisations après une exacerbation de bronchopneumopathie chronique obstructive? Mai 2014.
•   Haute autorité de santé. Evaluation et amélioration des pratiques. Grille de pilotage et de sécurité d'un projet de télémédecine, juin 2013.
•   Haute Autorité de Santé. Guide - Affections de longue durée. Diabète de type 1 de l'adulte, juillet 2007.
•   Haute Autorité de Santé. Guide de parcours de soins. Insuffisance cardiaque, juin 2014.
•   Haute Autorité de Santé. Guide du parcours de soins. Diabète de type 2 de l'adulte, mars 2014.
•   Haute Autorité de Santé. Rapport d'évaluation efficience de la télémédecine. Élaboration de matrices d'impacts des effets attendus de la télémédecine: applications aux chantiers prioritaires, juillet 2013.
•   Haute autorité de santé. Rapport d'évaluation médico-économique. Efficience de la télémédecine: état des lieux de la littérature internationale et cadre d'évaluation, juillet 2013