Clinical Trials for Elderly Patients With Multiple Disease

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— CHROMED  

Official title:

Clinical Trials for Elderly Patients With Multiple Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960907
• Other study ID #: CHROMEDB
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: September 29, 2016
• Start date: October 2013
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Restech Srl
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: Research Ethics CommitteeSlovenia: Ethics CommitteeSweden: Regional Ethical Review BoardSpain: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other typical comorbidities such as congestive heart failure and sleep disordered breathing. A specific ICT platform in combination with a set of innovative devices will be used to collect and process useful clinical data at the patient's home and used to optimize their medical treatment. To evaluate the impact of this solution, an international multi-centric randomized control trial will be implemented in five European regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social and organizational contexts in Europe.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• COPD GOLD grade II or higher with a prior history of exacerbations and/or an hospitalization for COPD in the previous year with one or more documented non-pulmonary chronic conditions such as:

• CHF due to left ventricular systolic dysfunction (LVSD) confirmed on echocardiography

• SDB identified by respiratory sleeping studies or polysomnography

• current or prior smoking history of >= 10 pack/years

• subjects capable of providing signed written informed consent

• subjects capable of perform study procedures and use the RESMONPRO at home

• subjects with reliable mobile phone coverage at home

Exclusion Criteria:

• Any disease that, in the opinion of the investigator, put the subject at risk

• subjects with significant vision disturbance and mental diseases

• subjects with a planned prolonged absence from home

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive Heart Failure (CHF)
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Sleep Disordered Breathing (SDB)

Intervention

Device:
• CHROMED monitoring system
Optimization of patient's treatment according to the data collected by the home monitoring devices

Locations

Country	Name	City	State
Estonia	Institute of Clinical Medicine	Tallin
Slovenia	Bolnisnica Sežana Zavod	Sežana
Spain	Hospital clinic	Barcelona
Sweden	Uppsala University Hospital	Uppsala
United Kingdom	Lincolnshire Community Health Service	Lincoln
United Kingdom	Aintree University Hospital	Liverpool

Sponsors (9)

Lead Sponsor	Collaborator
Restech Srl	Hospital of Sezana, Tesan spa, University Hospital of North Norway, University of Barcelona, University of Lincoln, University of Liverpool, University of Tallin, Uppsala University

Countries where clinical trial is conducted

Estonia,  Slovenia,  Spain,  Sweden,  United Kingdom, 

References & Publications (15)

Brouwer AF, Visser CA, Duiverman EJ, Roorda RJ, Brand PL. Is home spirometry useful in diagnosing asthma in children with nonspecific respiratory symptoms? Pediatr Pulmonol. 2010 Apr;45(4):326-32. doi: 10.1002/ppul.21183. — View Citation

Calverley P, Pauwels Dagger R, Löfdahl CG, Svensson K, Higenbottam T, Carlsson LG, Ståhl E. Relationship between respiratory symptoms and medical treatment in exacerbations of COPD. Eur Respir J. 2005 Sep;26(3):406-13. Erratum in: Eur Respir J. 2006 Feb;27(2):440. — View Citation

Dellacà R, Montserrat JM, Govoni L, Pedotti A, Navajas D, Farré R. Telemetric CPAP titration at home in patients with sleep apnea-hypopnea syndrome. Sleep Med. 2011 Feb;12(2):153-7. doi: 10.1016/j.sleep.2010.07.014. Epub 2011 Jan 17. — View Citation

Dellacà RL, Pompilio PP, Walker PP, Duffy N, Pedotti A, Calverley PM. Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD. Eur Respir J. 2009 Jun;33(6):1329-37. doi: 10.1183/09031936.00139608. Epub 2009 Jan 22. — View Citation

Dellacà RL, Santus P, Aliverti A, Stevenson N, Centanni S, Macklem PT, Pedotti A, Calverley PM. Detection of expiratory flow limitation in COPD using the forced oscillation technique. Eur Respir J. 2004 Feb;23(2):232-40. — View Citation

Feary JR, Rodrigues LC, Smith CJ, Hubbard RB, Gibson JE. Prevalence of major comorbidities in subjects with COPD and incidence of myocardial infarction and stroke: a comprehensive analysis using data from primary care. Thorax. 2010 Nov;65(11):956-62. doi: 10.1136/thx.2009.128082. Epub 2010 Sep 25. — View Citation

Johnson MK, Birch M, Carter R, Kinsella J, Stevenson RD. Measurement of physiological recovery from exacerbation of chronic obstructive pulmonary disease using within-breath forced oscillometry. Thorax. 2007 Apr;62(4):299-306. Epub 2006 Nov 14. — View Citation

MacDonald M, Fang J, Pittman SD, White DP, Malhotra A. The current prevalence of sleep disordered breathing in congestive heart failure patients treated with beta-blockers. J Clin Sleep Med. 2008 Feb 15;4(1):38-42. — View Citation

McKinstry B, Pinnock H, Sheikh A. Telemedicine for management of patients with COPD? Lancet. 2009 Aug 29;374(9691):672-3. doi: 10.1016/S0140-6736(09)61542-7. Review. — View Citation

McNicholas WT. Chronic obstructive pulmonary disease and obstructive sleep apnea: overlaps in pathophysiology, systemic inflammation, and cardiovascular disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):692-700. doi: 10.1164/rccm.200903-0347PP. Epub 2009 Jul 23. — View Citation

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):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2. Review. — View Citation

Rutten FH, Cramer MJ, Lammers JW, Grobbee DE, Hoes AW. Heart failure and chronic obstructive pulmonary disease: An ignored combination? Eur J Heart Fail. 2006 Nov;8(7):706-11. Epub 2006 Mar 13. Review. — View Citation

Spencer S, Calverley PM, Burge PS, Jones PW. Impact of preventing exacerbations on deterioration of health status in COPD. Eur Respir J. 2004 May;23(5):698-702. — View Citation

Vinson JM, Rich MW, Sperry JC, Shah AS, McNamara T. Early readmission of elderly patients with congestive heart failure. J Am Geriatr Soc. 1990 Dec;38(12):1290-5. — 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 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Hospitalization	It represents the number of days, since the enrolment into the study, to the first hospitalization	From enrolment up to 9 months	No
Primary	Final Utility Index of EQ-5D Questionnaire	The quality of life of patients as quantified by the final utility index of the EQ-5D questionnaire. The utility index ranges from -0.074 to 1 with 1 being the highest possible quality of life.	9 months	No

External Links

•   Official website of the CHROMED project