Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)
|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.|
|ClinicalTrials.gov Identifier: NCT01960907|
Recruitment Status : Completed
First Posted : October 11, 2013
Results First Posted : September 30, 2016
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD) Congestive Heart Failure (CHF) Sleep Disordered Breathing (SDB)||Device: CHROMED monitoring system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Trials for Elderly Patients With Multiple Disease|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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
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.
Device: CHROMED monitoring system
Optimization of patient's treatment according to the data collected by the home monitoring devices
- 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.
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
|Institute of Clinical Medicine|
|Tallin, Estonia, 12618|
|Bolnisnica Sežana Zavod|
|Sežana, Slovenia, 6210|
|Barcelona, Spain, 08036|
|Uppsala University Hospital|
|Uppsala, Sweden, SE-751 85|
|Lincolnshire Community Health Service|
|Lincoln, United Kingdom, LN6 7TS|
|Aintree University Hospital|
|Liverpool, United Kingdom, L9 7AL|
|Principal Investigator:||Peter Calverley, Phd, MD||University of Liverpool|