N/A
N=312
Clinical Trials for Elderly Patients With Multiple Disease
Chronic Obstructive Pulmonary Disease (COPD) · Congestive Heart Failure (CHF) · Sleep Disordered Breathing (SDB)
Bottom Line
View on ClinicalTrials.gov: NCT01960907 ↗Enrolled (actual)
312
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Time to First Hospitalization — 255; 224 days — p=0.342
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHROMED monitoring system (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Restech Srl
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Hospitalization |
255; 224 | 0.342 |
| PRIMARY Final Utility Index of EQ-5D Questionnaire |
0.640; 0.637 | 0.915 |
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
Data sourced from ClinicalTrials.gov (NCT01960907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.