Clinical Trials for Elderly Patients With Multiple Disease

NCT01960907 | Completed Results

• 1 other identifier: CHROMEDB
• Study Type: interventional
• Target: 312
• Locations: 4 countries
• Sites: 5

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure (CHF); Sleep Disordered Breathing (SDB)

Keywords

COPD; CHF; SDB

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Observational

NO INTERVENTION

Subjects in the observational arm will receive monthly interviews for collecting informations about their status and level of utilization of healthcare resources. They will follow their usual care path as provided by their local NHS

Interventional

EXPERIMENTAL

Patients will receive a system form monitoring their health status. The system is composed by: * a touch-screen pc for the administration of daily questionnaires * RESMONPRO DIARY for the measurement of lung mechanical impedance and breathing pattern * a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature. Subjects will receive medical treatment following the activation of alarms by the monitoring devices. Monthly phone interviews will be performed to collect data about their level of utilization of the health care system.

Device: CHROMED monitoring system

Interventions

CHROMED monitoring system DEVICE

Optimization of patient's treatment according to the data collected by the home monitoring devices

Interventional

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Restech Srl: lead
• University of Liverpool: collaborator
• Uppsala University: collaborator
• University of Lincoln: collaborator
• University of Tallin: collaborator
• University of Barcelona: collaborator
• Hospital of Sezana: collaborator
• University Hospital of North Norway: collaborator
• Tesan spa: collaborator

Study Sites (6)

Institute of Clinical Medicine

Tallinn, 12618, Estonia

Location

Bolnisnica Sežana Zavod

Sežana, 6210, Slovenia

Location

Hospital clinic

Barcelona, 08036, Spain

Location

Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

Lincolnshire Community Health Service

Lincoln, LN6 7TS, United Kingdom

Location

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

Related Publications (16)

• 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.

  PMID: 20196110 BACKGROUND

• Dellaca 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. doi: 10.1183/09031936.04.00046804.

  PMID: 14979497 BACKGROUND

• Dellaca 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.

  PMID: 19164347 BACKGROUND

• Dellaca R, Montserrat JM, Govoni L, Pedotti A, Navajas D, Farre 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.

  PMID: 21247800 BACKGROUND

• 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.

  PMID: 14990395 BACKGROUND

• 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. No abstract available.

  PMID: 19716948 BACKGROUND

• 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.

  PMID: 20871122 BACKGROUND

• 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. doi: 10.1111/j.1532-5415.1990.tb03450.x.

  PMID: 2254567 BACKGROUND

• 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.

  PMID: 18350960 BACKGROUND

• 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.

  PMID: 20197355 BACKGROUND

• 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. doi: 10.1016/j.ejheart.2006.01.010. Epub 2006 Mar 13.

  PMID: 16531114 BACKGROUND

• Calverley P, Pauwels Dagger R, Lofdahl CG, Svensson K, Higenbottam T, Carlsson LG, Stahl E. Relationship between respiratory symptoms and medical treatment in exacerbations of COPD. Eur Respir J. 2005 Sep;26(3):406-13. doi: 10.1183/09031936.05.00143404.

  PMID: 16135720 BACKGROUND

• 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. doi: 10.1183/09031936.04.00121404.

  PMID: 15176682 BACKGROUND

• 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.

  PMID: 19628778 BACKGROUND

• 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. doi: 10.1136/thx.2006.061044. Epub 2006 Nov 14.

  PMID: 17105778 BACKGROUND

• Middlemass JB, Vos J, Siriwardena AN. Perceptions on use of home telemonitoring in patients with long term conditions - concordance with the Health Information Technology Acceptance Model: a qualitative collective case study. BMC Med Inform Decis Mak. 2017 Jun 26;17(1):89. doi: 10.1186/s12911-017-0486-5.

  PMID: 28651588 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. Pasquale Pio Pompilio, R&D manager
• Organization: RESTECH srl

p.pompilio@restech.it

+39 02 3659 3690

Study Officials

• Peter Calverley, Phd, MD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 30, 2016
• Results First Posted: September 30, 2016

Record last verified: 2016-09

Locations

SE (1); GB (2); SL (1); ES (1)