Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)
Conditions
Keywords
COPD, CHF, SDB
Brief summary
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.
Interventions
DEVICECHROMED monitoring system
Optimization of patient's treatment according to the data collected by the home monitoring devices
Sponsors
University of Liverpool
Uppsala University
University of Lincoln
University of Tallin
University of Barcelona
Hospital of Sezana
University Hospital of North Norway
Tesan spa
Restech Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD GOLD grade II or higher with a prior history of exacerbations and/or an hospitalization for COPD in the previous year with one or more documented non-pulmonary chronic conditions such as: * CHF due to left ventricular systolic dysfunction (LVSD) confirmed on echocardiography * SDB identified by respiratory sleeping studies or polysomnography * current or prior smoking history of \>= 10 pack/years * subjects capable of providing signed written informed consent * subjects capable of perform study procedures and use the RESMONPRO at home * subjects with reliable mobile phone coverage at home
Exclusion criteria
* Any disease that, in the opinion of the investigator, put the subject at risk * subjects with significant vision disturbance and mental diseases * subjects with a planned prolonged absence from home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Hospitalization | 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 | 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. |
Countries
Estonia, Slovenia, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 158 |
| 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. | 154 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 3 |
| Overall Study | Withdrawal by Subject | 32 | 42 |
Baseline characteristics
| Characteristic | Interventional | Total | Observational |
|---|---|---|---|
| Age, Continuous | 71 years | 71 years | 71 years |
| FEV1/FVC postBD | 0.5 ratio | 0.5 ratio | 0.5 ratio |
| FEV1 postBD | 1.3 L | 1.3 L | 1.3 L |
| FEV1 postBD %pred | 49.4 %predicted | 49.8 %predicted | 50.4 %predicted |
| FVC postBD | 2.6 L | 2.5 L | 2.5 L |
| FVC postBD %pred | 73.8 %predicted | 75.0 %predicted | 75.8 %predicted |
| Patients with one or more hospitalization in the previous year | 64 participants | 129 participants | 65 participants |
| Patients with two or more COPD exacerbation in the previous year | 91 participants | 190 participants | 99 participants |
| Region of Enrollment Estonia | 41 participants | 80 participants | 39 participants |
| Region of Enrollment Slovenia | 17 participants | 33 participants | 16 participants |
| Region of Enrollment Spain | 31 participants | 61 participants | 30 participants |
| Region of Enrollment Sweden | 31 participants | 63 participants | 32 participants |
| Region of Enrollment United Kingdom | 34 participants | 75 participants | 41 participants |
| Sex: Female, Male Female | 53 Participants | 106 Participants | 53 Participants |
| Sex: Female, Male Male | 101 Participants | 206 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 158 | 0 / 154 |
| serious Total, serious adverse events | 0 / 158 | 0 / 154 |
Outcome results
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.
Time frame: 9 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational | Final Utility Index of EQ-5D Questionnaire | 0.640 units on a scale | Standard Deviation 0.248 |
| Interventional | Final Utility Index of EQ-5D Questionnaire | 0.637 units on a scale | Standard Deviation 0.225 |
p-value: 0.915t-test, 2 sided
Primary
Time to First Hospitalization
It represents the number of days, since the enrolment into the study, to the first hospitalization
Time frame: From enrolment up to 9 months
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Observational | Time to First Hospitalization | 255 days |
| Interventional | Time to First Hospitalization | 224 days |
p-value: 0.342Log Rank
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.
Time frame: Baseline and 9 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Observational | Difference of Hospitalization Rate | -1 hospitalizations/year/patient |
| Interventional | Difference of Hospitalization Rate | -1 hospitalizations/year/patient |
p-value: 0.038Wilcoxon (Mann-Whitney)