Trial Outcomes & Findings for Clinical Trials for Elderly Patients With Multiple Disease (NCT NCT01960907)
NCT ID: NCT01960907
Last Updated: 2016-09-30
Results Overview
It represents the number of days, since the enrolment into the study, to the first hospitalization
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
312 participants
Primary outcome timeframe
From enrolment up to 9 months
Results posted on
2016-09-30
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
154
|
|
Overall Study
COMPLETED
|
122
|
109
|
|
Overall Study
NOT COMPLETED
|
36
|
45
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
32
|
42
|
Baseline Characteristics
Clinical Trials for Elderly Patients With Multiple Disease
Baseline characteristics by cohort
| Measure |
Interventional
n=154 Participants
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
n=312 Participants
Total of all reporting groups
|
Observational
n=158 Participants
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
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=107 Participants
|
71 years
n=206 Participants
|
71 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
53 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
105 Participants
n=99 Participants
|
|
Region of Enrollment
Sweden
|
31 participants
n=107 Participants
|
63 participants
n=206 Participants
|
32 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
34 participants
n=107 Participants
|
75 participants
n=206 Participants
|
41 participants
n=99 Participants
|
|
Region of Enrollment
Slovenia
|
17 participants
n=107 Participants
|
33 participants
n=206 Participants
|
16 participants
n=99 Participants
|
|
Region of Enrollment
Estonia
|
41 participants
n=107 Participants
|
80 participants
n=206 Participants
|
39 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
31 participants
n=107 Participants
|
61 participants
n=206 Participants
|
30 participants
n=99 Participants
|
|
FEV1 postBD
|
1.3 L
n=107 Participants
|
1.3 L
n=206 Participants
|
1.3 L
n=99 Participants
|
|
FEV1 postBD %pred
|
49.4 %predicted
n=107 Participants
|
49.8 %predicted
n=206 Participants
|
50.4 %predicted
n=99 Participants
|
|
FVC postBD
|
2.6 L
n=107 Participants
|
2.5 L
n=206 Participants
|
2.5 L
n=99 Participants
|
|
FVC postBD %pred
|
73.8 %predicted
n=107 Participants
|
75.0 %predicted
n=206 Participants
|
75.8 %predicted
n=99 Participants
|
|
FEV1/FVC postBD
|
0.5 ratio
n=107 Participants
|
0.5 ratio
n=206 Participants
|
0.5 ratio
n=99 Participants
|
|
Patients with two or more COPD exacerbation in the previous year
|
91 participants
n=107 Participants
|
190 participants
n=206 Participants
|
99 participants
n=99 Participants
|
|
Patients with one or more hospitalization in the previous year
|
64 participants
n=107 Participants
|
129 participants
n=206 Participants
|
65 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From enrolment up to 9 monthsPopulation: 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.
It represents the number of days, since the enrolment into the study, to the first hospitalization
Outcome measures
| Measure |
Observational
n=158 Participants
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
n=154 Participants
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.
|
|---|---|---|
|
Time to First Hospitalization
|
255 days
Interval 240.0 to 270.0
|
224 days
Interval 209.0 to 240.0
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Observational
n=153 Participants
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
n=150 Participants
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.
|
|---|---|---|
|
Final Utility Index of EQ-5D Questionnaire
|
0.640 units on a scale
Standard Deviation 0.248
|
0.637 units on a scale
Standard Deviation 0.225
|
POST_HOC outcome
Timeframe: Baseline and 9 monthsDifference 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.
Outcome measures
| Measure |
Observational
n=64 Participants
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
n=65 Participants
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.
|
|---|---|---|
|
Difference of Hospitalization Rate
|
-1 hospitalizations/year/patient
Interval -1.0 to -0.15
|
-1 hospitalizations/year/patient
Interval -1.0 to 1.04
|
Adverse Events
Observational
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interventional
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place