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The Burden of a Remote Trial in a Nursing Home Setting: Qualitative Study

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Author(s)
Donnelly, Susie 
Reginatto, Brenda 
Kearns, Oisin 
Caulfield, Brian 
et al. 
Uri
http://hdl.handle.net/10197/9737
Date Issued
19 June 2018
Date Available
28T12:02:55Z March 2019
Abstract
Background: Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. Objective: The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. Methods: Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities co-ordinator, and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. Results: Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. Conclusions: A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.
Sponsorship
Enterprise Ireland
Science Foundation Ireland
Other Sponsorship
Applied Research for Connected Health
IDA
Type of Material
Journal Article
Publisher
JMIR
Journal
Journal of Medical Internet Research
Volume
20
Issue
6
Start Page
e220
Copyright (Published Version)
2018 the Authors
Keywords
  • mHealth

  • Patient burden

  • Remote trial

  • Clinical trial method...

  • Wearable technology

  • Activity monitors

DOI
10.2196/jmir.9638
Language
English
Status of Item
Peer reviewed
This item is made available under a Creative Commons License
https://creativecommons.org/licenses/by-nc-nd/3.0/ie/
Owning collection
Insight Research Collection
Scopus© citations
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Feb 5, 2023
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