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The Reaches Study: Design of an Innovative Patient Centric Trial in a Novel Setting



Designing a trial for older adults, using sensors and devices and mobile technology, that could be conducted in a non-traditional setting that would have the potential to reduce patient burden.
Aging Research App
Paper version of the
Age-Related Muscle
Loss Questionnaire(2)
has been deemed
suitable for use in both clinical
practice and clinical trial settings to
assess functional impacts of reduced
muscle strength in sarcopenia. An electronic
form of the questionnaire was delivered via the Apple ResearchKit
on iPad. The suitability of both the delivery methodology and
questionnaire will be assessed for this population in a residential
care home setting.
Aging Research Application
Aging Research Application
Authors: Marie Mc Carthy1, Bill Byrom1, Brenda Reginatto2 Susie Donnelly2
Barry Greene3, J. Patrick Bewley4, Willie Muehlhausen1, Oisin Kearns2
The REmote Assessment of older adults in a Care HomE Setting
(REACHES) project is an observational study to determine the
feasibility and acceptability of conducting a clinical trial within a
residential care home setting. The focus of this study is to evaluate
the practicalities and burden on both the site and the individual
care home residents when conducting a variety of longitudinal
assessments using mobile and wearable technologies within the
care home setting. Assessments include instrumented
performance tests using wearable devices (Performance
Outcomes (PerfOs), electronic patient reported outcomes
(ePRO), and daily assessment of activity and sleep and
heartrate using a wearable device.
This feasibility study will evaluate the acceptance of a
multifaceted trial in a research-naïve setting. The burden,
acceptability and practicalities of participation will be assessed
by semi-structured interviews and observation of study participants
and care home sta. It is generally accepted that within the context
of clinical trials, recruitment and retention of patients is challenging.
The traditional clinical trial design with centralized sites is particularly
burdensome in more elderly and frail populations where limited
mobility can impact the ability to participate in clinical trials (1).
Designing a trial that could be conducted in its entirety or in parts
in a non-traditional setting such as residential care home could
greatly reduce the need to travel. A combination of wearable
sensors, ePROs and PerfOs that could be used to generate data
for sensitive and responsive endpoints at the patient´s residence
has the potential to create a trial that is more patient-centric. This
may be particularly important for patients with Sarcopenia and other
diseases of aging and may potentially increase both recruitment and
retention rates.
Care home resident wearing the Garmin
Vivosmart HR device. Wear compliance,
the suitability of the device and the burden
on the individual residents and care team
will be assessed.
A TUG test assesses
mobility, balance,
walking ability, and
fall risk in older adults.
The REACHES study
uses Kinesis QTUG™, a
sensor-based, instrumented
PerfRo that provides gait and
mobility assessment, compared
to reference values, as well as
a statistical estimate of falls risk
and frailty (3).
The REACHES Study: Design of an Innovative
Patient Centric Trial in a Novel Setting
1 ICON PLC, Dublin, Ireland, 2 ARCH, Dublin, Ireland, 3 Kinesis Health Technologies, Dublin, Ireland, 4 Big Cloud Analytics, Atlanta, Georgia, USA
The project has three core objectives;
1. To assess the operational feasibility (i.e. logistics and impact on
sta 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.
2. To understand and measure the impact of “place-shifting” on care
home sta and physiotherapists involved in the trial.
3. To assess the acceptability, burden and practical considerations
associated with conducting trial procedures and using mobile and
wearable technologies for patients in a care home setting
• 25 care home residents will be recruited into the REACHES study
from a nursing home in Ireland.
• Patient Reported Outcomes (PROs) will be collected using an
electronic form of the “Age-Related Muscle Loss Questionnaire”
(2), delivered using ICON’s “Aging Research App” developed with
mProve Health (Arlington, VA) using Apple Research Kit.
• Risk of falls and frailty will be assessed at baseline and study-
completion, using Kinesis QTUG™ wearable sensor technology
for assessment of mobility and fall risk, based on the Timed Up
and Go (TUG) test.
• Daily activity and sleep patterns will be collected using the Garmin
Vivosmart HR device using.
• Use of the PRO instrument as applied to patients in the
non-independent-living setting of this trial will be investigated by
semi-structured interview with the participants.
• The acceptability, practical considerations and patient burden
will be assessed by semi structured interview and observation of
participants and care home sta.
1. Mody L, Miller, DK, McGloin JM, et al. Recruitment and
Retention of Older Adults in Aging Research. J Am Geriatr
Soc. 2008 December; 56(12): 2340–2348. doi:10.1111
2. Evans CJ, Chiou C, Fitzgerald KA. Et al. Development of a New
Patient- Reported Outcome Measure in Sarcopenia. J AM Med Dir
Assoc 2011: 12:226-233
3. Greene, B.R., S.J. Redmond, and B. Cauleld, Fall risk
assessment through automatic combination of clinical fall risk
factors and body-worn sensor data. IEEE Journal of Biomedical
and Health Informatics, 2016. PP(99): p. 1-1
The REmote Assessment of older adults in a Care HomE Setting
(REACHES) is a study to examine the feasibility of running
a clinical trial in a novel setting. A patient centric approach -
permeates all aspects of this novel trial design in the following
1. Place shifting from the traditional site to a novel setting of a
residential care home was included with an aim to reduce patient
burden and increase satisfaction with trial participation.
2. Engaging with a wider stakeholder circle of family, care-
home sta, other care home residents, nursing sta and the
physiotherapist to ensure adequate levels of support for the
duration of the trial is essential to increase retention.
3. The selection of a suitable set of sensors and devices to provide
clinically relevant endpoints that are meaningful for Sarcopenia
and present low burden for the sta and patients is a critical
component of the decision making and will be one of the key
learnings from the study.
Ensuring the generation of good quality data that was collected
and transmitted remotely in a manner that preserved and
maintained the patients privacy was the nal challenge for this
METHODS continued:
Clinical trial participation may be restricted in certain patient
populations due to limitations in mobility and independence. There
is a drive to design more patient-centric clinical trials that make
participation more engaging and convenient for patients. One
approach to consider is how assessments that are traditionally
conducted at a clinic visit can be performed within alternative
settings that are more convenient to the study participant. This
“place-shifting” may result in enabling wider participation and
engagement in clinical trials. Facilitated by technology solutions
that can be easily administered remotely, it may be possible to
deliver objective and clinically relevant health outcomes. For this
new model to succeed, however, it is vital to better understand the
impact of this “place-shifting” on all of the stakeholders involved as
this may greatly aect clinical trial outcomes.
The technical feasibility and implementation cost will also determine
in which scenarios this setting may be applied successfully.
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