Dataset Information

Monitoring Patients Reported Outcomes after Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results.

ABSTRACT: Wearable devices (WDs) can objectively assess patient-reported outcomes (PROMs) in clinical trials. In this study, the feasibility and acceptability of using commercial WDs in elderly patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) will be explored. This is a prospective observational study. Participants were trained to use a WD and a smartphone to collect data on their physical activity, rest heart rate and number of hours of sleep. Validated questionnaires were also used to evaluate these outcomes. A technology acceptance questionnaire was used at the end of the follow up. In our participants an overall good compliance in wearing the device (75.1% vs. 79.8%, SAVR vs. TAVR) was assessed. Half of the patients were willing to continue using the device. Perceived ease of use is one of the domains that scored higher in the technology acceptance questionnaire. In this study we observed that the use of a WD is accepted in our frail population for an extended period. Even though commercial WDs are not tailored for clinical research, they can produce useful information on patient behavior, especially when coordinated with intervention tailored to the single patient.

SUBMITTER: Ocagli H

PROVIDER: S-EPMC8297062 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Monitoring Patients Reported Outcomes after Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results.

Ocagli Honoria H Lorenzoni Giulia G Lanera Corrado C Schiavo Alessandro A D'Angelo Livio L Liberti Alessandro Di AD Besola Laura L Cibin Giorgia G Martinato Matteo M Azzolina Danila D D'Onofrio Augusto A Tarantini Giuseppe G Gerosa Gino G Cabianca Ester E Gregori Dario D

International journal of environmental research and public health 20210704 13

Wearable devices (WDs) can objectively assess patient-reported outcomes (PROMs) in clinical trials. In this study, the feasibility and acceptability of using commercial WDs in elderly patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) will be explored. This is a prospective observational study. Participants were trained to use a WD and a smartphone to collect data on their physical activity, rest heart rate and number of hours of sleep. ...[more]

PMID: 34281108

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Project description:BackgroundRecent innovations have the potential to disrupt the current paradigm for kidney failure treatment. The US Food and Drug Administration is committed to incorporating valid scientific evidence about how patients weigh the benefits and risks of new devices into their decision making, but to date, premarket submission of patient preference information (PPI) has been limited for kidney devices. With input from stakeholders, we developed a survey intended to yield valid PPI, capturing how patients trade off the potential benefits and risks of wearable dialysis devices and in-center hemodialysis.MethodsWe conducted concept elicitation interviews with individuals receiving dialysis to inform instrument content. After instrument drafting, we conducted two rounds of pretest interviews to evaluate survey face validity, comprehensibility, and perceived relevance. We pilot tested the survey with in-center hemodialysis patients to assess comprehensibility and usability further. Throughout, we used participant input to guide survey refinements.ResultsThirty-six individuals receiving in-center or home dialysis participated in concept elicitation (N=20) and pretest (N=16) interviews. Participants identified reduced fatigue, lower treatment burden, and enhanced freedom as important benefits of a wearable device, and many expressed concerns about risks related to device disconnection-specifically bleeding and infection. We drafted a survey that included descriptions of the risks of serious bleeding and serious infection and an assessment of respondent willingness to wait for a safer device. Input from pretest interviewees led to various instrument modifications, including treatment descriptions, item wording, and risk-level explanations. Pilot testing of the updated survey among 24 in-center hemodialysis patients demonstrated acceptable survey comprehensibility and usability, although 50% of patients required some assistance.ConclusionsThe final survey is a 54-item web-based instrument that will yield estimates of the maximal acceptable risk for the described wearable device and willingness to wait for wearable devices with lower risk.

Dataset Information

Monitoring Patients Reported Outcomes after Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results.

Publications

Monitoring Patients Reported Outcomes after Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results.

Similar Datasets

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