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Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

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ClinicalTrials.gov Identifier: NCT01960907
Recruitment Status : Completed
First Posted : October 11, 2013
Results First Posted : September 30, 2016
Last Update Posted : September 30, 2016
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

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
Enrollment 312
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Observational Interventional
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 158 154
Completed 122 109
Not Completed 36 45
Reason Not Completed
Death             4             3
Withdrawal by Subject             32             42
Arm/Group Title Observational Interventional Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 158 154 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 158 participants 154 participants 312 participants
71
(65.3 to 76)
71
(66 to 75.8)
71
(66 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 154 participants 312 participants
Female
53
  33.5%
53
  34.4%
106
  34.0%
Male
105
  66.5%
101
  65.6%
206
  66.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 158 participants 154 participants 312 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] 
Median (Inter-Quartile Range)
Unit of measure:  L
Number Analyzed 158 participants 154 participants 312 participants
1.3
(0.9 to 1.8)
1.3
(1.0 to 1.6)
1.3
(1.0 to 1.7)
[1]
Measure Description: Spirometrically measured Forced Exhaled Volume in 1 second (FEV1), measured after a maximal dose of a bronchodilator drug
FEV1 postBD %pred   [1] 
Median (Inter-Quartile Range)
Unit of measure:  %predicted
Number Analyzed 158 participants 154 participants 312 participants
50.4
(38 to 63.9)
49.4
(37.1 to 59.2)
49.8
(37.2 to 62.1)
[1]
Measure Description: 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] 
Median (Inter-Quartile Range)
Unit of measure:  L
Number Analyzed 158 participants 154 participants 312 participants
2.5
(2.1 to 3.1)
2.6
(2.0 to 3.1)
2.5
(2.0 to 3.1)
[1]
Measure Description: 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] 
Median (Inter-Quartile Range)
Unit of measure:  %predicted
Number Analyzed 158 participants 154 participants 312 participants
75.8
(63.0 to 89.7)
73.8
(61.8 to 88.0)
75.0
(62.2 to 89.0)
[1]
Measure Description: Forced Vital Capacity measured after bronchodilation expressed as percentage of its predicted value.
FEV1/FVC postBD   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ratio
Number Analyzed 158 participants 154 participants 312 participants
0.5
(0.4 to 0.6)
0.5
(0.4 to 0.6)
0.5
(0.4 to 0.6)
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 158 participants 154 participants 312 participants
99 91 190
Patients with one or more hospitalization in the previous year  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 158 participants 154 participants 312 participants
65 64 129
1.Primary Outcome
Title Time to First Hospitalization
Hide Description It represents the number of days, since the enrolment into the study, to the first hospitalization
Time Frame From enrolment up to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Observational Interventional
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 158 154
Mean (Inter-Quartile Range)
Unit of Measure: days
255
(240 to 270)
224
(209 to 240)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observational, Interventional
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.342
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title Final Utility Index of EQ-5D Questionnaire
Hide Description 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.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Observational Interventional
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 153 150
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.640  (0.248) 0.637  (0.225)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observational, Interventional
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.915
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Post-Hoc Outcome
Title Difference of Hospitalization Rate
Hide Description 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.
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Monitored, Previously Hopitalized for COPD Exacerbation Observational, Previously Hopitalized for COPD Exacerb.
Hide Arm/Group Description:
Patients in the monitored group that were hospitalized the year before the study for a COPD exacerbation
Patients in the observational group that were hospitalized the year before the study for a COPD exacerbation
Overall Number of Participants Analyzed 64 65
Median (Inter-Quartile Range)
Unit of Measure: hospitalizations/year/patient
-1
(-1 to -0.15)
-1
(-1 to 1.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monitored, Previously Hopitalized for COPD Exacerbation, Observational, Previously Hopitalized for COPD Exacerb.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Observational Interventional
Hide Arm/Group Description

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

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.

All-Cause Mortality
Observational Interventional
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Observational Interventional
Affected / at Risk (%) Affected / at Risk (%)
Total   0/158 (0.00%)   0/154 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Observational Interventional
Affected / at Risk (%) Affected / at Risk (%)
Total   0/158 (0.00%)   0/154 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Pasquale Pio Pompilio, R&D manager
Organization: RESTECH srl
Phone: +39 02 3659 3690
EMail: p.pompilio@restech.it
Publications:
Layout table for additonal information
Responsible Party: Pasquale Pio Pompilio, 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