| Literature DB >> 35774115 |
Hari G Dandapani1, Natalie M Davoodi1,2, Lucie C Joerg1, Melinda M Li1, Daniel H Strauss1,2, Kelly Fan1, Talie Massachi1, Elizabeth M Goldberg1,2.
Abstract
Clinical researchers are using mobile-based sensors to obtain detailed and objective measures of the activity and health of research participants, but many investigators lack expertise in integrating wearables and sensor technologies effectively into their studies. Here, we describe the steps taken to design a study using sensors for disease monitoring in older adults and explore the benefits and drawbacks of our approach. In this study, the Geriatric Acute and Post-acute Fall Prevention Intervention (GAPcare), we created an iOS app to collect data from the Apple Watch's gyroscope, accelerometer, and other sensors; results of cognitive and fitness tests; and participant-entered survey data. We created the study app using ResearchKit, an open-source framework developed by Apple for medical research that includes neuropsychological tests (e.g., of executive function and memory), gait speed, balance, and other health assessments. Data is transmitted via an Application Programming Interface (API) from the app to REDCap for researchers to monitor and analyze in real-time. Employing the lessons learned from GAPcare could help researchers create study-tailored research apps and access timely information about their research participants from wearables and smartphone devices for disease prevention, monitoring, and treatment.Entities:
Keywords: Apple Watch; Research Electronic Data Capture (REDCap); Researchkit; falls; mobile applications; smartphones
Year: 2022 PMID: 35774115 PMCID: PMC9237242 DOI: 10.3389/fdgth.2022.893070
Source DB: PubMed Journal: Front Digit Health ISSN: 2673-253X
Figure 1High-level study workflow for the GAPcare II study. We began by creating the surveys for the relevant fields in REDCap. Then, we programmed the app to send the relevant measurements from HealthKit, which measures health data in the iPhone and Apple Watch. We then determined which Active Tasks to include in our study based on our study goals. Then we enabled the REDCap API, allowing members of the research team to perform tests to verify that data collected from the app was sent to REDCap. Once we verified that the app worked as intended, we began field testing the app with older adult patients from the ED.
Figure 2Screenshots from the ResearchKit active task: Gait and balance.
Figure 3Screenshots from the ResearchKit active task: trail making test.
Figure 4REDCap dashboard: illustrates the home screen of a given research study in REDCap. Researchers may click into specific participants or metrics for further detail.
Figure 5REDCap active tasks: results from active tasks in REDCap. In this example, researchers may download the results from the trail making test for analysis. Also included are the start and end times for the active task.
Figure 6REDCap survey data: results from a survey in REDCap. Surveys were included in earlier versions of the GAPcare II protocol. Included is the participant's answer to the survey and the interval during which they completed the survey.
Observed benefits of using the Apple Watch-ResearchKit-REDCap tech stack.
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| Consumer experience | Participants with a wide level of prior technical experience can still learn to use the app with proper training, instruction, and guidance. The Apple Watch's simple aesthetic makes it more palatable to a broader variety of participant populations |
| Data management | Data files are easily accessible and manageable by research staff on REDCap. Files can be downloaded for use in all major statistical languages including SAS, Stata, and R |
| Data management | ResearchKit allows for the collection of a broad variety of data types, including physiological data, survey data, and Active Task results |
| Data transfer | Data is transferred to REDCap via the API as soon as it is finalized, rather than relying on traditional, more time-consuming methods of data collection, like diaries, calendars, and paper surveys |
| Design and development | ResearchKit and REDCap are ready for use off the shelf for non-experts in technical development, serving to democratize access to research app development |
| Instrument development | Streamlined creation of forms in REDCap, coupled with the ability to edit the study app, allows for shifts in information being collected if the study needs to adapt |
| Portability | Participants are able to complete some study tasks from any location, instead of having to complete them in a controlled study environment |
| Privacy and cost | REDCap is HIPAA-compliant and free for researchers at most health systems |
| Remote consent | ResearchKit includes a module for electronic consent for study participants, reducing the participant burden of completing extensive paperwork |
| User access | Simple permissions management for members of the research team allows for new staff to be added easily to the project and for the Principal Investigator to specify limits on access, including who can download identifiable data and who can create and delete new study subjects |
Challenges of using the Apple Watch-ResearchKit-REDCap tech stack and recommended mitigations.
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| Data analysis | ResearchKit's data from Active Tasks and sensor data is often presented without sufficient context and, therefore, is hard to analyze and interpret without adequate understanding or experience | Create tools for converting the data to a more visualizable format, such as code to present all data on one Excel sheet. Additionally, hire a dedicated medical statistician on the team |
| Device access and connectivity | Participants need to have a stable internet connection in order to collect and transmit information | Screen participants for stable internet access before enrollment. Provide participants with a hotspot for the duration of the study |
| Digital divide based on participant demographics | Older adults with low previous technology exposure had difficulty using the app and completing Active Tasks, leading to poor data collection. | Screen older adults for technical capability before enrollment to gauge the training support needed for your project. Provide technical training as needed to eligible participants |
| Environmental barriers | Some Active Tasks can require mobility or access to open spaces, which are not universally availabl. | Have participants perform those Active Tasks in a research setting |
| Missing data | Some participants may not complete Active Tasks, surveys, or other assessments, which can lead to lapses in data collection. This can also occur if the participant is not able to charge their device | Regularly check in with study participants to ensure their continued participation in the study. Use completion metrics from REDCap to direct which participants you contact |
| Tech support | Less technically capable participants might need support from the research team to complete study tasks | Providing a simple, printed user manual for the app and allowing participants to contact the research team can mitigate this issue. If budgeting allows, hire a part time staff member who solely addresses study technology concerns |
| Technology inventory | Using multiple platforms can result in participants being identified by various IDs, (i.e., study ID, status/post username, REDCap ID) which can be overwhelming or lead to data errors | Accurate data management in REDCap forms and other software can help identify participants by differing IDs. Diligent tracking of all participant IDs from all platforms, such as on an Excel spreadsheet, can be helpful for ensuring data quality |
Figure 7Sample analysis of data and REDCap and generated report card for study participant.
Suggested study team composition for studies involving wearables.
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| Clinical researcher/scientist | Oversee human subjects protection, provide study oversight, conduct team meetings, design study to meet research aims, communicate with sponsors, obtain funding |
| Research assistant | Communicate with participants, perform research tasks with participants, teach participants how to use the technology, troubleshoot technology concerns with participants |
| Computer scientist / biomedical engineer | Develop software, create websites, program instruments, troubleshoot technology problems, provide suggestions on improving usability of wearables |
| Data scientist | Data processing and quality control, create, and vet workflow for efficient data process and more accurate analyses |
| Data manager | Monitor for lapses in wearable use or connectivity, perform quality checks, ensure safe data storage |
| Developer | Program research app, make modifications depending on study findings |