Clinical trial NCT01960907: Clinical Trials for Elderly Patients With Multiple Disease
Official title: Clinical Trials for Elderly Patients With Multiple Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Congestive Heart Failure (CHF)
Sleep Disordered Breathing (SDB)
Keywords: COPD
CHF
SDB
Lead sponsor: Restech Srl
Sponsor class: INDUSTRY
Collaborators: name: University of Liverpool
name: Uppsala University
name: University of Lincoln
name: University of Tallin
name: University of Barcelona
name: Hospital of Sezana
name: University Hospital of North Norway
name: Tesan spa
First posted: 2013-10-11
Enrollment: 312
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Time to First Hospitalization
timeFrame: From enrolment up to 9 months
measure: Final Utility Index of EQ-5D Questionnaire
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tallin
country: Estonia
facility: Institute of Clinical Medicine
city: Sežana
country: Slovenia
facility: Bolnisnica Sežana Zavod
city: Barcelona
country: Spain
facility: Hospital clinic
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Lincoln
country: United Kingdom
facility: Lincolnshire Community Health Service
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
Study officials:
affiliation: University of Liverpool
name: Peter Calverley, Phd, MD
role: PRINCIPAL_INVESTIGATOR
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