Clinical trial for elderly patients with Multiple Diseases (CHROMED)V1
Research type
Research Study
Full title
Randomised clinical control trial of a new home monitoring system for patients with multimorbidities; Chronic obstructive pulmonary disease (COPD) with Chronic heart failure (CHF) or Ischaemic Heart Disease.
IRAS ID
125764
Contact name
Paul Walker
Contact email
Sponsor organisation
Aintree Univeristy Hospital NHS Foundation Trust
Research summary
There is some evidence that home monitoring of symptoms improves quality of life and reduces health care costs for ongoing illnesses such as COPD. The European Commission has funded a large clinical trial (CHROMED) in seven countries to test whether daily home recording of clinical data helps patients better manage their condition, improves well-being and mitigates health crises.
All patients will have a baseline assessment that includes medical history, symptom and health status questionnaires and lung function measurements. These measurements will be performed at the study site.
Patients will be randomised to home monitoring or control and monitored over a nine month period. Patients in the intervention arm will have the CHROMED home monitoring system installed at home and will carry out daily measurement of their lung function, blood pressure and oxygen saturation levels and complete short symptom questionnaires. This data will be uploaded daily and monitored and any change in the patient’s condition will result in contact and often intervention by the study team.
Patients in the control group will continue to receive usual medical follow-up but will be asked to complete daily short symptoms questionnaires.
There will be a series of follow-up phone contacts for all patients in the study. There will be quarterly completion of health status questionnaires and details of health and social care usage and costs will be recorded and noted. The practicalities of using the system will be examined as will the ability of home monitoring to identify disease flare ups.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0748
Date of REC Opinion
22 Oct 2013
REC opinion
Favourable Opinion