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Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

CHROMED monitoring system

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, CHF, SDB

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of Clinical Medicine
Bolnisnica Sežana Zavod
Hospital clinic
Uppsala University Hospital
Lincolnshire Community Health Service
Aintree University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observational

Interventional

Arm Description

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: a touch-screen pc for the administration of daily questionnaires RESMONPRO 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 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.

Outcomes

Primary Outcome Measures

Time to First Hospitalization

It represents the number of days, since the enrolment into the study, to the first hospitalization

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01960907

First Posted

October 9, 2013

Last Updated

September 29, 2016

Sponsor

Restech Srl

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

1. Study Identification

Unique Protocol Identification Number

NCT01960907

Brief Title

Clinical Trials for Elderly Patients With Multiple Disease

Acronym

CHROMED

Official Title

Clinical Trials for Elderly Patients With Multiple Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Restech Srl

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)

Keywords

COPD, CHF, SDB

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Observational

Arm Type

No Intervention

Arm Description

Arm Title

Interventional

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

CHROMED monitoring system

Intervention Description

Optimization of patient's treatment according to the data collected by the home monitoring devices

Primary Outcome Measure Information:

Title

Time to First Hospitalization

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

Title

Final Utility Index of EQ-5D Questionnaire

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Calverley, Phd, MD

Organizational Affiliation

University of Liverpool

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Clinical Medicine

City

Tallin

ZIP/Postal Code

12618

Country

Estonia

Facility Name

Bolnisnica Sežana Zavod

City

Sežana

ZIP/Postal Code

6210

Country

Slovenia

Facility Name

Hospital clinic

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Uppsala University Hospital

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Lincolnshire Community Health Service

City

Lincoln

ZIP/Postal Code

LN6 7TS

Country

United Kingdom

Facility Name

Aintree University Hospital

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

12. IPD Sharing Statement

Citations:

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20196110

Citation

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Results Reference

derived

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Clinical Trials for Elderly Patients With Multiple Disease

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