November 2016 | End Date:
Project Lead: Brenda Reginatto, Research Lead, Care Team, ARCH
Collaborators: ICON, Kinesis Health Technologies, Big Cloud Analytics, Inc.
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.
The aim of this exploratory study is to assess the feasibility of collecting clinical outcomes remotely in a care home setting (Mount Hybla Private, in Castleknock, Dublin), using a selection of mobile and wearable solutions provided by the collaborating companies, and understand how this might direct the approach used if trials are place-shifted to residential care settings.
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.
To assess the operational feasibility (i.e. logistics and impact on staff and patients) and technical feasibility (i.e. data capture and data transfer) of collecting clinical outcomes data remotely using the above mentioned mobile and wearable technologies in a care home setting.
1. To identify the different elements of burden that a remote trial places on care home staff and patients during the trial journey.
2. To assess the perceived value of using mobile and wearable solutions to collect data to patients and care home staff.
3. To investigate QTUG (Kinesis Health Technologies, Ireland) use as part of a clinical trial in a residential care setting.
4. To obtain user-experience data from ICON’s Aging Research App.
5. Evaluate and select a suitable activity tracker for the purpose of this study using ARCH Device Evaluation Framework.
6. To obtain insights into the typical patient populations encountered in a care home setting.
Potential Impact for Industry
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.
For more information
Please contact the Project Lead, Brenda Reginatto on 01 716 5403 or email firstname.lastname@example.org.