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| Name | Class |
|---|---|
| University of Liverpool | OTHER |
| Uppsala University | OTHER |
| University of Lincoln | OTHER |
| University of Tallin |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHROMED monitoring system | Device | Optimization of patient's treatment according to the data collected by the home monitoring devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Calverley, Phd, MD | University of Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Medicine | Tallinn | 12618 | Estonia | |||
| Bolnisnica Sežana Zavod |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20196110 | Background | 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. | |
| 14979497 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational | Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources. They followed their usual care path as provided by their local NHS. |
| FG001 | Interventional | Patients received a system for monitoring their health status. The system is composed by:
Subjects received medical treatment following the activation of alarms by the monitoring devices. Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational | Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources. They followed their usual care path as provided by their local NHS |
| BG001 | Interventional |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Hospitalization | It represents the number of days, since the enrolment into the study, to the first hospitalization | An intention to treat analysis has been applied for the primary outcomes of the trial and all the randomized patients have been retained for the analysis. | Posted | Mean | Inter-Quartile Range | days | From enrolment up to 9 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational | Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources. They followed their usual care path as provided by their local NHS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pasquale Pio Pompilio, R&D manager | RESTECH srl | +39 02 3659 3690 | p.pompilio@restech.it |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| UNKNOWN |
| University of Barcelona | OTHER |
| Hospital of Sezana | UNKNOWN |
| University Hospital of North Norway | OTHER |
| Tesan spa | UNKNOWN |
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| Sežana |
| 6210 |
| Slovenia |
| Hospital clinic | Barcelona | 08036 | Spain |
| Uppsala University Hospital | Uppsala | SE-751 85 | Sweden |
| Lincolnshire Community Health Service | Lincoln | LN6 7TS | United Kingdom |
| Aintree University Hospital | Liverpool | L9 7AL | United Kingdom |
| 19164347 | 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. |
| 21247800 | 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. |
| 14990395 | 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. |
| 19716948 | 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. |
| 20871122 | 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. |
| 2254567 | 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. |
| 18350960 | 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. |
| 20197355 | 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. |
| 16531114 | 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. |
| 16135720 | 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. |
| 15176682 | 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. |
| 19628778 | 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. |
| 17105778 | 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. |
| 28651588 | Derived | 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. |
Patients received a system for monitoring their health status. The system is composed by:
Subjects received additional medical treatment following the activation of alarms by the monitoring devices. Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FEV1 postBD | Spirometrically measured Forced Exhaled Volume in 1 second (FEV1), measured after a maximal dose of a bronchodilator drug | Median | Inter-Quartile Range | L |
|
| FEV1 postBD %pred | Forced Exhaled Volume in 1 second (FEV1) measured after the administration of a maximal dose of bronchodilator expressed as percentage of predicted value. | Median | Inter-Quartile Range | %predicted |
|
| FVC postBD | Forced Vital Capacity (FVC) after brochodilation: maximum volume of air exhaled during a full forced exhalation from the maximum to the minimum lung volume achievable by the subject measured after the administration of a maximal dose of a bronchodilator drug. | Median | Inter-Quartile Range | L |
|
| FVC postBD %pred | Forced Vital Capacity measured after bronchodilation expressed as percentage of its predicted value. | Median | Inter-Quartile Range | %predicted |
|
| FEV1/FVC postBD | Ratio between Forced Exhaled Volume in 1 second (FEV1) and the Forced Vital capacity (FVC) | Median | Inter-Quartile Range | ratio |
|
| Patients with two or more COPD exacerbation in the previous year | Number | participants |
|
| Patients with one or more hospitalization in the previous year | Number | participants |
|
Patients received a system for monitoring their health status.
The system is composed by:
Subjects received additional medical treatment following the activation of alarms by the monitoring devices.
Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources.
|
|
|
| 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. | An intention to treat analysis has been applied for the primary outcomes of the trial. Multiple Imputation (MI) was used to assign values were data were missing. However for a limited number of patient, due to the fact that all data were missing, we couldn't apply any imputation method and therefore they have been excluded. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Post-Hoc | Difference of Hospitalization Rate | Difference between the hospitalization rate during the study and the previous year. For each patient, hospitalization rate was defined as the number of hospital admissions during a period divided by the length (in days) of the period. Number of hospitalizations was collected by the hospital clinical records. | Posted | Median | Inter-Quartile Range | hospitalizations/year/patient | Baseline and 9 months |
|
|
|
|
| 0 |
| 158 |
| 0 |
| 158 |
| EG001 | Interventional | Patients received a system for monitoring their health status. The system is composed by:
Subjects received additional medical treatment following the activation of alarms by the monitoring devices. Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources. | 0 | 154 | 0 | 154 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |