Tag Archives: clinical trial

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Patients and health professionals join research team to hear about early CHROMED study findings

chromedevent1Research participants along with their spouse or carer, and health professionals who took part in the CHROMED trial were invited to a feedback session on Wednesday 23rd March at the Petwood Hotel in Woodhall Spa to mark the end of the study and to hear about initial results from the trial.

 

chromedteamCHROMED (Clinical Trials for Elderly Patients with Multiple Diseases) is a European Commission (Framework 7) funded randomised control trial (RCT) which was conducted over three years in seven European countries. The study looked at the impact of telemonitoring equipment in the homes of older people (aged 60 years or over) with a chronic condition commonly known as COPD (Chronic Obstructive Pulmonary Disease) and an associated heart condition. The University of Lincoln and Lincolnshire Community Health Services NHS Trust (LCHS) collaborated closely on this study with partners in Liverpool, Italy, Spain, Sweden, Norway, Estonia, and Slovenia.

chromedevent2Dr Jo Middlemass, study research nurse, gave a presentation detailing the early results. In the feasibility (testing) phase a new breathing device (Resmon Pro) was shown to have identified a chest infection five days before it was treated. It was too early to present the results from the main study but Jo described the findings from interviews carried out with those participants who had the equipment in their homes. David Madeley (technician from Electronic Assistive Technology Service at LCHS) set up the equipment at the event to give everyone who wished to do so, and particularly those who were in the observation arm, an opportunity to try the equipment.

The event was positively received and culminated in a delicious afternoon tea!

By Dr Jo Middlemass

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CaHRU team attends CHROMED European trial meeting in Uppsala, Sweden

Dr Jo Middlemass, trial nurse, and Prof Niro Siriwardena who are members of the Clinical Trials for Elderly Patients with Multiple Diseases (CHROMED) (Funding by the European Commission’s 7th Framework Programme) attended the final investigator team meeting in Uppsala earlier this month (March 2016).

IMG_4175The study includes a consortium of seven European countries led by TESAN (Italy), Restech and including Del Politcnico Di Milano (Italy), University of Liverpool (UK), Tallina Tehnikaulikool (Estonia), Universitat De Barcelona (Spain), Uppsala Universitet (Sweden), Universitetssykehuset Nord-Norge (Norway), Bolnisnica Sezana Zavod (Slovenia), University of Lincoln, Lincolnshire Community Health Services NHS Trust.

The CHROMED study has been investigating the effectiveness and cost-effectiveness of a telemonitoring system for people with multiple chronic disease, specifically Chronic Obstructive Pulmonary Disease (COPD) and heart disease. The trial in Lincoln involved a feasibility study of five patients and a randomisation cohort of 32 patients aged 65 years and above in Lincolnshire. The monitoring equipment included a novel device for measuring lung function (using a technique called forced oscillation) and a wrist clinic measuring pulse, blood pressure, oxygen saturation, and temperature.

chromedThe study has already shown evidence that monitoring can detect patients’ worsening condition, even before symptoms are apparent. The study data have now been collected and are being analysed to see whether the monitoring system has improved patients’ outcomes, quality of life and healthcare costs.

 

 

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Study on service user involvement in a prehospital clinical trial of falls published in Trials

EMAS - PTS 2_750One of the few studies of service user involvement in a clinical trials was published this month in the journal Trials: ‘Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model‘. The study was part of the SAFER2 (Support and Assessment for Fall Emergency Referrals) trial led by the University of Swansea with Ambulance Services in the East Midlands, London and Wales and involving CaHRU at the University of Lincoln. The study was led by Bridie Evans and the trial lead was Prof Helen Snooks, both from Swansea University.

EMAS - A&E 5The study describes how it was planned for service users to be involved in the trial and how involvement actually occurred. The study team planned for service users to be involved at strategic level, at each study site and locally and this did take place. For example at strategic level, service users were involved in the trial management, EMAS - PTS 7trial steering, and data monitoring and ethics committees In addition, service users were also involved in study writing days and task and finish groups. Service users were also involved at study sites. Finally, service user reference groups were consulted at various points during the study.

Overall, the study showed how service users could be integrated into the activities of a clinical trial, the processes involved and facilitators and barriers to involvement at various levels.