Study to assess feasibility of collecting clinical trial data in a care home environment

Dublin, Ireland, 8 February 2017, ARCH, the Centre for Applied Research for Connected Health (www.arch.ie), today announced the launch of a collaborative study to assess the feasibility of collecting clinical trial data remotely within a care home environment.

The findings from this connected health study could enhance the design of future clinical trials to make them more patient-centric, more engaging and more convenient for those who participate in them. Researchers will also assess if the remote trial places additional burden on care home staff and patients.

ARCH is undertaking this research study, called REACHES (REmote Assessment of older people in a Care HomE Setting), in collaboration with industry partners; ICON Clinical Research, Kinesis Health Technologies, a University College Dublin (UCD) spin-out company, and Big Cloud Analytics and supported by Dublin-based Physiotherapy Clinic, Fit for Life.

Clinical trials traditionally take place in a hospital setting, which often restricts participation from patients with limited mobility and independence due to problematic logistics and limited travel ability.

An alternative approach is to move the clinical trial beyond the confines of the hospital. Enabling this ‘place-shifting’ may result in wider participation and engagement in clinical trials.

Led by a team of ARCH researchers, this study will assess the feasibility of collecting clinical trial data remotely in a care home, Mount Hybla Private, in Castleknock, Dublin, using a selection of mobile and wearable solutions provided by the collaborating companies.

REACHES study launch

Pictured (l-r) at the Mount Hybla Private care home are; Michael O’Shea, ARCH Centre Director; Marie McCarthy, Director of Product Innovation, ICON; Ciara Sheridan, Assistant Director of Nursing, Mount Hybla Private; Mark Sweeney, MD, Fit For Life; Anastasia Kitova, Charted Physiotherapist at Fit For Life; Brenda Reginatto, Research Lead, ARCH; Dr Barry Greene, Chief Technology Officer, Kinesis Health Technologies; Dr Susan Donnelly, Post-Doctoral Research Fellow, ARCH.

The QTUG™ device provided by Kinesis Health Technologies, will assess aspects of mobility, balance and fall risk of participants. The Aging Research App developed by ICON with mProve Health (based in Arlington, Virginia) using Apple Research Kit, will be used to deliver an electronic version of the Age-Related Muscle Loss Questionnaire. The Covalence™ analytics platform from Big Cloud Analytics (headquartered in Atlanta, Georgia) will allow visualisation and engagement messaging for trial participants and clinicians for overall health and wellness monitoring and improvement.

Deployment, monitoring and evaluation of these technologies in Mount Hybla Private will be co-ordinated and driven by ARCH.

Pictured (l-r) at the Mount Hybla Private care home are; Kitty Doyle (care home resident) and Anastasia Kitova, Charted Physiotherapist at Fit For Life

Pictured (l-r) at the Mount Hybla Private care home are; Kitty Doyle (care home resident) and Anastasia Kitova, Charted Physiotherapist at Fit For Life

Announcing the study, Michael O’Shea, ARCH Centre Director, said,

“I’m delighted to see this academic-industry-clinical multi-disciplinary collaboration taking place. Traditional clinical trial research is becoming financially unfeasible. Sponsors and clinical research organisations (CROs) are looking to decrease costs and improve efficiency. An important strategy is the use of technology in the design and execution of clinical trials. The promise and potential benefits of the “Patient Centric” clinical trial design needs to be traded off against what is referred to as the “patient burden”.

He added, “The importance of understanding the optimal level of interaction with technology and devices for patients is key to successful trial design and execution and projects like this are a fundamental step in answering this question.”

Dr Barry Greene, Chief Technology Officer, Kinesis Health Technologies said,

“We are delighted to partner with ARCH and with leading companies ICON and Big Cloud, to work to see how our evidence-based mobility and fall risk assessment technology can improve clinical trials of the future.”

ARCH, the Irish national centre for applied connected health research, is headquartered at NexusUCD, the Industry Partnership Centre at UCD. As an industry-led technology centre, funded by Enterprise Ireland and the IDA, ARCH provides access to world-class healthcare professionals, academics, patient cohorts and industry networks to explore and evaluate connected health solutions for the global market.

ARCH focuses on the adoption, deployment and sustainability of connected health solutions which will benefit the Irish and international economy and society.

Over 30 industry partners, from start-ups to multinationals, are currently steering ARCH’s research programme.

These industry partners; S3 Group, Vu2Vu, Hermitage Medical Clinic, Novartis, ADA Security Systems, Relate Care, Two Ten Health, Philips Healthcare, ResMed, ICON, SwiftQueue, HealthBridge Technology, Dolmen, PatientMpower, Nurse Buddy, Hewlett Packard Enterprise, Salaso Healthcare, McGreal Group, Caragon, Evolve Technologies, nSilico Lifescience, Neuromod Devices, Odyssey Validation Consultants, Kinesis Health Technologies, Medaval, Insulcheck, Foundry Innovation & Research 1 (FIRE 1), 3rd Pillar Clinical, Big Cloud Analytics and IBM; are all actively involved in the connected health sector.

ENDS

8 February 2017

For further information contact Micéal Whelan, University College Dublin, Communications Manager (Innovation), t: + 353 1 716 3712, e: miceal.whelan@ucd.ie, or Michael O’Shea, Centre Director, ARCH, t: +353 1 716 5404, e: moshea@arch.ie.

Editors Notes

ARCH is a government funded (Enterprise Ireland/IDA) technology centre hosted by UCD with University of Limerick as a partner and a panel of collaborating technology institutes and universities. The Centre carries out state funded applied research in connected health that has an industry focus.

ARCH has clinical/patient access via its host institution, UCD, which is the academic partner to the Ireland East Hospital Group (11 hospitals, 1 million+ patients) as well as through a network of General Practices and Primary Care teams all over Ireland.  www.arch.ie

Kinesis Health Technologies, founded in 2013, has developed a new proprietary technology that uses wearable sensor-based devices to improve the accuracy of falls-risk assessments. The company recently raised €590,000 in funding from a consortium of private investors alongside a high-potential start-up (HPSU) investment from Enterprise Ireland as it seeks to boost international sales of its intelligent diagnostic devices. It is currently headquartered at NexusUCD, the industry partnership centre at UCD. www.kinesishealthtech.com

Big Cloud Analytics is a global data science company and a leader in delivering analytics software solutions associated with wearable devices. Supporting insurance, healthcare and companies, BCA’s end-to-end solution includes wearable and other devices, algorithms for real-time predictive analytics, wellness scoring, bio-identification and end-user and administrative dashboards. www.bigcloudanalytics.com

ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 88 locations in 37 countries and has approximately 12,600 employees. www.iconplc.com