A Study to Examine the Feasibility of Running a Clinical Trial
The REACHES study considered how assessments that are traditionally conducted at a clinic visit
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. The focus of this study is the evaluation of the practicalities and burden on 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. Conducting remote studies frequently involves the co-operation of many partners and the REACHES study is a collaborative connected health project in association with ARCH (Dublin, Ireland), ICON PLC (Dublin, Ireland), Kinesis Health Technologies (Dublin, Ireland) and Big Cloud Analytics (Atlanta, Georgia). 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. The REACHES study considered 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 enable 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 understand the impact of this ‘place-shifting’ on the stakeholders involved as this may greatly affect clinical trial outcomes.
The REACHES Study
Assessing 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.
Designing a patient centric trial is a significant challenge for those involved in drug development and is a key focus area for the pharmaceutical industry. There is increasing attention given to a more patient centric approach and designing trials that make participation more engaging and convenient. It is generally accepted within the context of clinical trials, that recruitment and retention of patients is a significant issue and is a key barrier for drug development and one of the main factors impacting clinical trial costs (1). This is particularly true for trials involving older adults who are often poorly represented in drug development trials where participation may be restricted in due to limitations in mobility and independence and practical issues involved in getting to the trial sites for weekly or month site visits. The traditional approach, employing centralised sites is burdensome for this population, particularly for those older adults who are frail and might have concerns about falls and mobility and subsequently have more difficulties with travel and may need caregiver assistance. Mody et al (2) recommended that, when looking at the general principles of recruitment and retention of older adults in research studies, strategies around remote data collection to reduce the travel burden and promote participation should be developed.
The inclusion of older adults in clinical trials will become increasing problematic as the global population ages. Older adults face unique health challenges and disease burden, a factor likely to impact health care spending in both developed and developing countries. One such disease area is sarcopenia. Sarcopenia is a disease that is seen by many as an accepted part of the aging process. It has been defined by the European Working Group on Sarcopenia in Older People (EWGSOP) as “a syndrome characterised by progressive and generalised loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death” (3). The resulting loss of muscle mass contributes to increased levels of frailty, which in turn affects gait and balance. Frailty is a complex clinical condition closely linked to increased risk of falls, comorbidity and increased hospitalisation (4). Increased risk of falls in turn contributes to fear of falling, impacting daily activities, potentially restricting the older adult from participating in everyday activities, and can lead to loss of independence. As the population ages, the significance and impact of sarcopenia is set to grow. Sarcopenia is thought to affect 30% of individuals over 60 years of age and more than 50% of people over 80 years (5). If we take the US as an example of a developed country with an aging population, we see that the number of Americans aged 65 and older is projected to be over 98 million by 2060 (6). These figures mean that in the US alone, sarcopenia could impact the lives of between 29.4 and 49 million older adults.
The REACHES Study has three core aims:
- To explore how technology solutions can be implemented and leveraged to provide clinical assessments in a care home setting for an elderly patient population.
- To understand and measure the impact of “place-shifting” on care home staff and physiotherapists involved in the trial.
- To assess the burden of wearable sensors and remote monitoring on patients participating in the trial. The technologies used in the study were ones that could be used in a sacropenia study to generate outcomes measures that reflected muscle function. and included:
- Aging Research App (ICON Clinical Research, Dublin, Ireland) – a tablet app providing tests for spatial memory and numeric working memory, and a patient reported outcomes instrument related to sarcopenia.
- QTUG™ (Kinesis Health Technologies, Dublin, Ireland) – an instrumented version of the Timed-Up-And-Go (TUG) test. The QTUG™ product assesses aspects of mobility, balance and fall risk. It has applicability as a clinic-based assessment in a number of disease indications including stroke, fracture, dementia, and sarcopenia, alzheimer’s disease, parkinson’s disease and MS.
- Garmin Vivosmart HR (Olathe, Kanas) and the CovalenceTM (Big Cloud Analytics, Atlanta, Georgia); the platform for analytics and insight, visualisation and engagement messaging for both client and clinician for overall health and wellness monitoring and improvement.
The burden, acceptability and practicalities of participation will be assessed by semi-structured interviews and observation of study participants and care home staff.
The REACHES study is a feasibility study designed to evaluate the acceptance of a multifaceted trial in a research-naive setting. It is generally accepted that within the context of clinical trials, recruitment and retention of patients is challenging. Designing a trial that could be conducted in its entirety or in parts in a non-traditional setting such as residential home care could greatly reduce the need to travel. For this new model to succeed, it is vital to better understand the impact of this “place-shifting” on all of the stakeholders involved as this may greatly affect clinical trial outcomes. The design and testing of an innovative method for assessing patient burden related to the use of wearable technology devices and sensors is a key outcome of this study. It is hoped that the REACHES study, will also provide the following; insights into the clinical trial journey map and identify shortcomings within, obtain initial validation and user-experience data from ICON’s Aging Research App. It is also hoped that data from this study can be used to design and pilot an instrument for the assessment of patient burden related to the use of wearable technology devices and sensors and finally to obtain insight into the typical patient populations encountered in a care home setting.
References:
- Eastern Research Group, Inc. Examination of clinical trial costs and barriers for Drug Development, July 25, 2014. Accessed 29/09/2015
- 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/j.1532-5415.2008.02015.x
- Cruz-Jentoft AJ, Baeyens JP, Bauer JM et al Sarcopenia: European consensus on definition and diagnosis Age and Ageing 2010; 39: 412–423 doi: 10.1093/ageing/afq034
- Fried LP, Tangen CM, Walston J et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001; 56: M146–57.Baumgartner RN, Koehler KM, Gallagher D, et al. Epidemiology of sarcopenia among the elderly in New Mexico. American Journal of Epidemiology 1998; 147:755–763.
- Baumgartner RN, Koehler KM, Gallagher D, et al. Epidemiology of sarcopenia among the elderly in New Mexico. American Journal of Epidemiology 1998; 147:755–763.
- Mather M, Jacobsen LA, Pollard KM, Population Reference Bureau. Population Bulletin.