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Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01960907
First Posted: October 11, 2013
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Liverpool
Uppsala University
University of Lincoln
University of Tallin
University of Barcelona
Hospital of Sezana
University Hospital of North Norway
Tesan spa
Information provided by (Responsible Party):
Pasquale Pio Pompilio, Restech Srl
  Purpose
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.

Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Congestive Heart Failure (CHF) Sleep Disordered Breathing (SDB) Device: CHROMED monitoring system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Trials for Elderly Patients With Multiple Disease

Further study details as provided by Pasquale Pio Pompilio, Restech Srl:

Primary Outcome Measures:
  • Time to First Hospitalization [ Time Frame: From enrolment up to 9 months ]
    It represents the number of days, since the enrolment into the study, to the first hospitalization

  • Final Utility Index of EQ-5D Questionnaire [ Time Frame: 9 months ]
    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.


Enrollment: 312
Study Start Date: October 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observational

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

Experimental: Interventional

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960907


Locations
Estonia
Institute of Clinical Medicine
Tallin, Estonia, 12618
Slovenia
Bolnisnica Sežana Zavod
Sežana, Slovenia, 6210
Spain
Hospital clinic
Barcelona, Spain, 08036
Sweden
Uppsala University Hospital
Uppsala, Sweden, SE-751 85
United Kingdom
Lincolnshire Community Health Service
Lincoln, United Kingdom, LN6 7TS
Aintree University Hospital
Liverpool, United Kingdom, L9 7AL
Sponsors and Collaborators
Restech Srl
University of Liverpool
Uppsala University
University of Lincoln
University of Tallin
University of Barcelona
Hospital of Sezana
University Hospital of North Norway
Tesan spa
Investigators
Principal Investigator: Peter Calverley, Phd, MD University of Liverpool
  More Information

Additional Information:
Publications:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Responsible Party: Pasquale Pio Pompilio, PhD, Restech Srl
ClinicalTrials.gov Identifier: NCT01960907     History of Changes
Other Study ID Numbers: CHROMEDB
First Submitted: October 9, 2013
First Posted: October 11, 2013
Results First Submitted: July 26, 2016
Results First Posted: September 30, 2016
Last Update Posted: September 30, 2016
Last Verified: September 2016

Keywords provided by Pasquale Pio Pompilio, Restech Srl:
COPD
CHF
SDB

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases


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