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Published in: BMC Health Services Research 1/2011

Open Access 01-12-2011 | Study protocol

Assessment of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease. The TELBIL study

Authors: Iñaki Martín-Lesende, Estibalitz Orruño, Carmen Cairo, Amaia Bilbao, José Asua, María I Romo, Itziar Vergara, Juan C Bayón, Roberto Abad, Eva Reviriego, Jesús Larrañaga

Published in: BMC Health Services Research | Issue 1/2011

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Abstract

Background

Telemonitoring technology offers one of the most promising alternatives for the provision of health care services at the patient's home. The primary aim of this study is to evaluate the impact of a primary care-based telemonitoring intervention on the frequency of hospital admissions.

Methods/design

A primary care-based randomised controlled trial will be carried out to assess the impact of a telemonitoring intervention aimed at home care patients with heart failure (HF) and/or chronic lung disease (CLD). The results will be compared with those obtained with standard health care practice. The duration of the study will be of one year. Sixty patients will be recruited for the study. In-home patients, diagnosed with HF and/or CLD, aged 14 or above and with two or more hospital admissions in the previous year will be eligible.
For the intervention group, telemonitoring will consist of daily patient self-measurements of respiratory-rate, heart-rate, blood pressure, oxygen saturation, weight and body temperature. Additionally, the patients will complete a qualitative symptom questionnaire daily using the telemonitoring system. Routine telephone contacts will be conducted every fortnight and additional telephone contacts will be carried out if the data received at the primary care centre are out of the established limits. The control group will receive usual care. The primary outcome measure is the number of hospital admissions due to any cause that occurred in a period of 12 months post-randomisation. The secondary outcome measures are: duration of hospital stay, hospital admissions due to HF or CLD, mortality rate, use of health care resources, quality of life, cost-effectiveness, compliance and patient and health care professional satisfaction with the new technology.

Discussion

The results of this study will shed some light on the effects of telemonitoring for the follow-up and management of chronic patients from a primary care setting. The study may contribute to enhance the understanding of alternative modes of health care provision for medically unstable elderly patients, who bear a high degree of physical and functional deterioration.

Trial Registration

Appendix
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Literature
3.
go back to reference Spanish Ministry of Health and Social Policy. IMSERSO: Las personas mayores en España. Regional and National Data. 2008 Report. 2009, ARTEGRAF S.A. Madrid, II. Spanish Ministry of Health and Social Policy. IMSERSO: Las personas mayores en España. Regional and National Data. 2008 Report. 2009, ARTEGRAF S.A. Madrid, II.
5.
go back to reference Conway G: Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006, 5 (1): 25-28.CrossRefPubMed Conway G: Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006, 5 (1): 25-28.CrossRefPubMed
6.
go back to reference Wilkinson T, Donaldson GC, Hurst JR, Seemungal TAR, Wedzicha JA: Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004, 169: 1298-1303. 10.1164/rccm.200310-1443OC.CrossRefPubMed Wilkinson T, Donaldson GC, Hurst JR, Seemungal TAR, Wedzicha JA: Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004, 169: 1298-1303. 10.1164/rccm.200310-1443OC.CrossRefPubMed
7.
go back to reference Pare G, Jaana M, Sicotte C: Systematic review of home telemonitoring for chronic diseases: the evidence base. J Am Med Inform Assoc. 2007, 14 (3): 269-277. 10.1197/jamia.M2270.CrossRefPubMedPubMedCentral Pare G, Jaana M, Sicotte C: Systematic review of home telemonitoring for chronic diseases: the evidence base. J Am Med Inform Assoc. 2007, 14 (3): 269-277. 10.1197/jamia.M2270.CrossRefPubMedPubMedCentral
8.
go back to reference Cleland JGF, Louis AA, Rugby AS, Janssens U, Balk AHMM: Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death. The Trans-European Network-Home-Care Management System (TEN-HMS) Study. J Am Coll Cardiol. 2005, 45 (10): 1654-1664. 10.1016/j.jacc.2005.01.050.CrossRefPubMed Cleland JGF, Louis AA, Rugby AS, Janssens U, Balk AHMM: Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death. The Trans-European Network-Home-Care Management System (TEN-HMS) Study. J Am Coll Cardiol. 2005, 45 (10): 1654-1664. 10.1016/j.jacc.2005.01.050.CrossRefPubMed
9.
go back to reference Sisk JE, Hebert PL, Horowitz CR, McLaughlin MA, Wang JJ, Chassin MR: Effects of nurse management on the quality of heart failure care in minority communities: a randomised trial. Ann Int Med. 2006, 145 (4): 273-83.CrossRefPubMedPubMedCentral Sisk JE, Hebert PL, Horowitz CR, McLaughlin MA, Wang JJ, Chassin MR: Effects of nurse management on the quality of heart failure care in minority communities: a randomised trial. Ann Int Med. 2006, 145 (4): 273-83.CrossRefPubMedPubMedCentral
10.
go back to reference Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupré A, Bégin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP: Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease specific self-management intervention. Arch Intern Med. 2003, 163: 585-91. 10.1001/archinte.163.5.585.CrossRefPubMed Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupré A, Bégin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP: Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease specific self-management intervention. Arch Intern Med. 2003, 163: 585-91. 10.1001/archinte.163.5.585.CrossRefPubMed
11.
go back to reference Kielblock B, Frye Ch, Kottmair S, Hudler T, Siegmund-Schultze E, Middeke M: Impact of telemetric management on overall treatment costs and mortality rate among patients with chronic heart failure. Deutsche Medizinische Wochenschrift. 2007, 132 (9): 417-22. 10.1055/s-2007-970350.CrossRefPubMed Kielblock B, Frye Ch, Kottmair S, Hudler T, Siegmund-Schultze E, Middeke M: Impact of telemetric management on overall treatment costs and mortality rate among patients with chronic heart failure. Deutsche Medizinische Wochenschrift. 2007, 132 (9): 417-22. 10.1055/s-2007-970350.CrossRefPubMed
12.
go back to reference Giordano A, Scalvini S, Zanelli E, Corrà U, Longobardi GL, Ricci VA, et al: Multicentre randomised trial on home-based telemanagement to prevent hospital readmission of patients with chronic heart failure. Int J Cardiol. 2009, 131 (2): 192-9. 10.1016/j.ijcard.2007.10.027.CrossRefPubMed Giordano A, Scalvini S, Zanelli E, Corrà U, Longobardi GL, Ricci VA, et al: Multicentre randomised trial on home-based telemanagement to prevent hospital readmission of patients with chronic heart failure. Int J Cardiol. 2009, 131 (2): 192-9. 10.1016/j.ijcard.2007.10.027.CrossRefPubMed
13.
go back to reference Farrero E, Escarrabill J, Prats E, Maderal M, Manresa F: Impact of a hospital-based home-care program on the management of COPD patients receiving long-term oxygen therapy. Chest. 2001, 119 (2): 364-369. 10.1378/chest.119.2.364.CrossRefPubMed Farrero E, Escarrabill J, Prats E, Maderal M, Manresa F: Impact of a hospital-based home-care program on the management of COPD patients receiving long-term oxygen therapy. Chest. 2001, 119 (2): 364-369. 10.1378/chest.119.2.364.CrossRefPubMed
14.
go back to reference Pare G, Sicotte C, St-Jules D, Gauthier R: Cost-minimization analysis of a telehomecare program for patients with chronic obstructive pulmonary disease. Telemed J E-Health. 2006, 12 (2): 114-121. 10.1089/tmj.2006.12.114.CrossRefPubMed Pare G, Sicotte C, St-Jules D, Gauthier R: Cost-minimization analysis of a telehomecare program for patients with chronic obstructive pulmonary disease. Telemed J E-Health. 2006, 12 (2): 114-121. 10.1089/tmj.2006.12.114.CrossRefPubMed
15.
go back to reference Tran K, Polisena J, Coyle D, Coyle K, Kluge E-HW, Cimon K, McGill S, Noorani H, Palmer K, Scott R: Home telehealth for chronic disease management [Technology report number 113]. 2008, Ottawa: Canadian Agency for Drugs and Technologies in Health Tran K, Polisena J, Coyle D, Coyle K, Kluge E-HW, Cimon K, McGill S, Noorani H, Palmer K, Scott R: Home telehealth for chronic disease management [Technology report number 113]. 2008, Ottawa: Canadian Agency for Drugs and Technologies in Health
16.
go back to reference Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE: Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010, 16 (3): 120-127. 10.1258/jtt.2009.090812.CrossRefPubMed Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE: Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010, 16 (3): 120-127. 10.1258/jtt.2009.090812.CrossRefPubMed
17.
go back to reference Clark RA, Inglis SC, McAlister FA, Cleland JGF, Stewart S: Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta analysis. BMJ. 2007, 334 (7600): 942-10.1136/bmj.39156.536968.55.CrossRefPubMedPubMedCentral Clark RA, Inglis SC, McAlister FA, Cleland JGF, Stewart S: Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta analysis. BMJ. 2007, 334 (7600): 942-10.1136/bmj.39156.536968.55.CrossRefPubMedPubMedCentral
18.
go back to reference Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JGF: Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database of Systematic Reviews. 2010, CD007228-8 Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JGF: Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database of Systematic Reviews. 2010, CD007228-8
19.
go back to reference Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE: Home telemonitoring for congestive heart failure: a systematic review and meta-analysis. J Telemed Telecare. 2010, 16 (2): 68-76. 10.1258/jtt.2009.090406.CrossRefPubMed Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE: Home telemonitoring for congestive heart failure: a systematic review and meta-analysis. J Telemed Telecare. 2010, 16 (2): 68-76. 10.1258/jtt.2009.090406.CrossRefPubMed
20.
go back to reference Bagües MI, Rodríguez J: Servicio de telemetria orientado a enfermos crónicos: una plataforma software especializada en multipatologias. XII National Congress on Health Informatics. InforSalud: 16-18. 2009, March . Madrid Bagües MI, Rodríguez J: Servicio de telemetria orientado a enfermos crónicos: una plataforma software especializada en multipatologias. XII National Congress on Health Informatics. InforSalud: 16-18. 2009, March . Madrid
21.
go back to reference Morisky DE, Green LW, Levine DM: Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986, 24: 67-74. 10.1097/00005650-198601000-00007.CrossRefPubMed Morisky DE, Green LW, Levine DM: Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986, 24: 67-74. 10.1097/00005650-198601000-00007.CrossRefPubMed
22.
go back to reference Mahoney FI, Barthel DW: Functional evaluation: the Barthel Index. Md Med J. 1965, 14: 61-65. Mahoney FI, Barthel DW: Functional evaluation: the Barthel Index. Md Med J. 1965, 14: 61-65.
23.
go back to reference Badía X, Roset M, Montserrat S, Herdman M, Segura A: La versión española del EuroQol: descripción y aplicaciones. Med Clín. 1999, 112 (Suppl 1): 79-85. Badía X, Roset M, Montserrat S, Herdman M, Segura A: La versión española del EuroQol: descripción y aplicaciones. Med Clín. 1999, 112 (Suppl 1): 79-85.
24.
go back to reference Herdman M, Badia X, Berra S: El EuroQol-5D: una alternativa sencilla para la medición de la calidad de vida relacionada con la salud en atención primaria. Aten Primaria. 2001, 28 (6): 425-429.CrossRefPubMed Herdman M, Badia X, Berra S: El EuroQol-5D: una alternativa sencilla para la medición de la calidad de vida relacionada con la salud en atención primaria. Aten Primaria. 2001, 28 (6): 425-429.CrossRefPubMed
25.
go back to reference Oppe M, Rabin R, de Charro F: EQ-5D User Guide. EuroQol Group. Version 1.0. 2007 Oppe M, Rabin R, de Charro F: EQ-5D User Guide. EuroQol Group. Version 1.0. 2007
26.
go back to reference Zarit S, Orr N, Zarit J: The hidden victims of Alzheimer's disease: families under stress. 1985, New York: University Press Zarit S, Orr N, Zarit J: The hidden victims of Alzheimer's disease: families under stress. 1985, New York: University Press
27.
go back to reference Martín M, Salvadó I, Nadal S, Miji LC, Rico JM, Lanz P, et al: Adaptación para nuestro medio de la Escala de sobrecarga del Cuidador (Caregiver Burden Interview) de Zarit. Rev Gerontol. 1996, 6: 338-346. Martín M, Salvadó I, Nadal S, Miji LC, Rico JM, Lanz P, et al: Adaptación para nuestro medio de la Escala de sobrecarga del Cuidador (Caregiver Burden Interview) de Zarit. Rev Gerontol. 1996, 6: 338-346.
28.
go back to reference Izal M, Montorio I: Evaluación del medio y del cuidador del demente. Evaluación neuropsicológica y funcional de la demencia. Edited by: Del Ser T, Peña Casanova J. 1994, Barcelona: Prous Science, 201-202. Izal M, Montorio I: Evaluación del medio y del cuidador del demente. Evaluación neuropsicológica y funcional de la demencia. Edited by: Del Ser T, Peña Casanova J. 1994, Barcelona: Prous Science, 201-202.
29.
go back to reference Bakken S, Grullon-Figueroa L, Izquierdo R, Lee NJ, Morin P, Palmas W, et al: Development, validation, and use of English and Spanish versions of the telemedicine satisfaction and usefulness questionnaire. J Am Med Inform Assoc. 2006, 13: 660-667. 10.1197/jamia.M2146.CrossRefPubMedPubMedCentral Bakken S, Grullon-Figueroa L, Izquierdo R, Lee NJ, Morin P, Palmas W, et al: Development, validation, and use of English and Spanish versions of the telemedicine satisfaction and usefulness questionnaire. J Am Med Inform Assoc. 2006, 13: 660-667. 10.1197/jamia.M2146.CrossRefPubMedPubMedCentral
30.
go back to reference Demiris G, Speedie S, Finkelstein S: A questionnaire for the assessment of patients' impressions of the risks and benefits of home telecare. J Telemed Telecare. 2001, 6: 278-284. 10.1258/1357633001935914.CrossRef Demiris G, Speedie S, Finkelstein S: A questionnaire for the assessment of patients' impressions of the risks and benefits of home telecare. J Telemed Telecare. 2001, 6: 278-284. 10.1258/1357633001935914.CrossRef
31.
go back to reference Yip MP, Chang AM, Chan J, Mackenzie AE: Development of the telemedicine satisfaction questionnaire to evaluate patient satisfaction with telemedicine: a preliminary study. J Telemed Telecare. 2003, 9: 46-50. 10.1258/135763303321159693.CrossRefPubMed Yip MP, Chang AM, Chan J, Mackenzie AE: Development of the telemedicine satisfaction questionnaire to evaluate patient satisfaction with telemedicine: a preliminary study. J Telemed Telecare. 2003, 9: 46-50. 10.1258/135763303321159693.CrossRefPubMed
32.
go back to reference Chaudhry SI, Phillips CO, Stewart SS, Riegel BJ, Mattera JA, Jerano AF: Telemonitoring for patients with Chronic Herat Failure: a systematic review. J Card Fail. 2007, 13 (1): 56-62. 10.1016/j.cardfail.2006.09.001.CrossRefPubMedPubMedCentral Chaudhry SI, Phillips CO, Stewart SS, Riegel BJ, Mattera JA, Jerano AF: Telemonitoring for patients with Chronic Herat Failure: a systematic review. J Card Fail. 2007, 13 (1): 56-62. 10.1016/j.cardfail.2006.09.001.CrossRefPubMedPubMedCentral
33.
go back to reference Benatar D, Bondmass M, Ghitelman J, Avitall B: Outcomes of chronic heart failure. Arch Intern Med. 2003, 163 (3): 347-352. 10.1001/archinte.163.3.347.CrossRefPubMed Benatar D, Bondmass M, Ghitelman J, Avitall B: Outcomes of chronic heart failure. Arch Intern Med. 2003, 163 (3): 347-352. 10.1001/archinte.163.3.347.CrossRefPubMed
34.
go back to reference Bondmass M, Benatar JD, Castro G, Avitall B: A prospective randomised study comparing outcomes and outpatient care delivery methods for chronic heart failure. J Am Coll Cardiol. 2001, 37: 1A-648A. 10.1016/S0735-1097(01)80001-2.CrossRef Bondmass M, Benatar JD, Castro G, Avitall B: A prospective randomised study comparing outcomes and outpatient care delivery methods for chronic heart failure. J Am Coll Cardiol. 2001, 37: 1A-648A. 10.1016/S0735-1097(01)80001-2.CrossRef
35.
go back to reference Manca A, Hawkins N, Sculpher MJ: Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Economics. 2005, 14: 487-496. 10.1002/hec.944.CrossRefPubMed Manca A, Hawkins N, Sculpher MJ: Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Economics. 2005, 14: 487-496. 10.1002/hec.944.CrossRefPubMed
36.
go back to reference Briggs AH, Wonderling DE, Mooney CZ: Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Economics. 1997, 6: 327-340. 10.1002/(SICI)1099-1050(199707)6:4<327::AID-HEC282>3.0.CO;2-W.CrossRefPubMed Briggs AH, Wonderling DE, Mooney CZ: Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Economics. 1997, 6: 327-340. 10.1002/(SICI)1099-1050(199707)6:4<327::AID-HEC282>3.0.CO;2-W.CrossRefPubMed
Metadata
Title
Assessment of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease. The TELBIL study
Authors
Iñaki Martín-Lesende
Estibalitz Orruño
Carmen Cairo
Amaia Bilbao
José Asua
María I Romo
Itziar Vergara
Juan C Bayón
Roberto Abad
Eva Reviriego
Jesús Larrañaga
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2011
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-11-56

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