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Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01960907
First received: October 9, 2013
Last updated: September 29, 2016
Last verified: September 2016
Results First Received: July 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Congestive Heart Failure (CHF)
Sleep Disordered Breathing (SDB)
Intervention: Device: CHROMED monitoring system

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Interventional

Patients received a system for monitoring their health status.

The system is composed by:

  • a touch-screen pc for the administration of daily questionnaires
  • RESMON PRO 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 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.


Participant Flow:   Overall Study
    Observational   Interventional
STARTED   158   154 
COMPLETED   122   109 
NOT COMPLETED   36   45 
Death                4                3 
Withdrawal by Subject                32                42 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Interventional

Patients received a system for monitoring their health status.

The system is composed by:

  • a touch-screen pc for the administration of daily questionnaires
  • RESMON PRO 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 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.

Total Total of all reporting groups

Baseline Measures
   Observational   Interventional   Total 
Overall Participants Analyzed 
[Units: Participants]
 158   154   312 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 71 
 (65.3 to 76) 
 71 
 (66 to 75.8) 
 71 
 (66 to 76) 
Gender 
[Units: Participants]
     
Female   53   53   106 
Male   105   101   206 
Region of Enrollment 
[Units: Participants]
     
Sweden   32   31   63 
United Kingdom   41   34   75 
Slovenia   16   17   33 
Estonia   39   41   80 
Spain   30   31   61 
FEV1 postBD [1] 
[Units: L]
Median (Inter-Quartile Range)
 1.3 
 (0.9 to 1.8) 
 1.3 
 (1.0 to 1.6) 
 1.3 
 (1.0 to 1.7) 
[1] Spirometrically measured Forced Exhaled Volume in 1 second (FEV1), measured after a maximal dose of a bronchodilator drug
FEV1 postBD %pred [1] 
[Units: %predicted]
Median (Inter-Quartile Range)
 50.4 
 (38 to 63.9) 
 49.4 
 (37.1 to 59.2) 
 49.8 
 (37.2 to 62.1) 
[1] Forced Exhaled Volume in 1 second (FEV1) measured after the administration of a maximal dose of bronchodilator expressed as percentage of predicted value.
FVC postBD [1] 
[Units: L]
Median (Inter-Quartile Range)
 2.5 
 (2.1 to 3.1) 
 2.6 
 (2.0 to 3.1) 
 2.5 
 (2.0 to 3.1) 
[1] 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.
FVC postBD %pred [1] 
[Units: %predicted]
Median (Inter-Quartile Range)
 75.8 
 (63.0 to 89.7) 
 73.8 
 (61.8 to 88.0) 
 75.0 
 (62.2 to 89.0) 
[1] Forced Vital Capacity measured after bronchodilation expressed as percentage of its predicted value.
FEV1/FVC postBD [1] 
[Units: Ratio]
Median (Inter-Quartile Range)
 0.5 
 (0.4 to 0.6) 
 0.5 
 (0.4 to 0.6) 
 0.5 
 (0.4 to 0.6) 
[1] Ratio between Forced Exhaled Volume in 1 second (FEV1) and the Forced Vital capacity (FVC)
Patients with two or more COPD exacerbation in the previous year 
[Units: Participants]
 99   91   190 
Patients with one or more hospitalization in the previous year 
[Units: Participants]
 65   64   129 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to First Hospitalization   [ Time Frame: From enrolment up to 9 months ]

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

3.  Post-Hoc:   Difference of Hospitalization Rate   [ Time Frame: Baseline and 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Pasquale Pio Pompilio, R&D manager
Organization: RESTECH srl
phone: +39 02 3659 3690
e-mail: p.pompilio@restech.it


Publications:


Responsible Party: Pasquale Pio Pompilio, Restech Srl
ClinicalTrials.gov Identifier: NCT01960907     History of Changes
Other Study ID Numbers: CHROMEDB
Study First Received: October 9, 2013
Results First Received: July 26, 2016
Last Updated: September 29, 2016